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A summary of a study, which may be published alone or as an introduction to a full scientific paper.

Academic Health and Science Networks (AHSN)

An organisation which helps align education, clinical research, informatics, innovation, training and education and healthcare delivery. The AHSN’s goal is to improve patient and population health outcomes by translating research into practice, and developing and implementing integrated health care services.

Academic In Confidence

See ‘In Confidence Material’.

Accelerated Access Collaborative (AAC)

The Accelerated Access Collaborative (AAC) is the decision-making body for the Accelerated Access Pathway (AAP) which arose from the Accelerated Access Review (AAR).

See the AAC page on MAP here.

Accelerated Access Review (AAR)

The Accelerated Access Review (AAR) was an independently-chaired review commissioned by the UK Government in November 2014. The final report makes recommendations to make it easier for NHS patients to access innovative medicines, medical technologies, diagnostics and digital products, improving efficiency and patient outcomes.


The extent to which people are able to receive the information, services or care they need.

Active Implantable Medical Device

Any active medical device which is intended to be totally or partially introduced, surgically or medically, into the human body or by medical intervention into a natural orifice, and which is intended to remain after the procedure.

Active Medical Device

Any medical device relying for its functioning on a source of electrical energy or any source of power other than that directly generated by the human body or gravity.

Acute Trust (AT)

Some hospitals in England are managed by acute trusts, some of which have also gained foundation trust status. Acute trusts ensure that hospitals provide high-quality healthcare and check they spend their money efficiently. They also decide how a hospital will develop to improve services. Acute trusts can also provide services in the community.

Most hospitals in England are now managed by NHS foundation trusts. Foundation Trusts are independent legal entities and have unique governance arrangements. They have financial freedoms and can raise capital from both the public and private sectors within borrowing limit.

Adaptive Pathway

The adaptive pathway seeks to balance timely access for patients who are likely to benefit most from the medicine with the need to provide adequate evolving information on the benefits and risks of the medicine itself, bringing the drug to market through iterative phases of evidence gathering and licensing, with further approval of adjustments based on post-market trials and real-world evidence.

Advanced Therapy Medicinal Products (ATMP)

The term Advanced Therapy Medicinal Products (ATMP) is applied to products involving cells, genes or tissues. For example, many regenerative medicines, personalised treatments and nanomedicines can be considered ATMPs.

See the ATMP page on MAP here.

Adverse Drug Reaction (ADR)

A reaction to a medicine which is harmful, or potentially harmful, to a patient. If a reaction happens while a patient is taking a medicine, it may have been caused by the medicine, but it may have another cause, such as the disease being treated. For this reason they are sometimes called ‘adverse events’. ADR is used for those reactions which are likely to have been caused by the medicine.


Academic Health Science Centre

All Wales Medicines Strategy Group (AWMSG)

The AWMSG is the Welsh health technology appraisal (HTA) body,  a statutory advisory Welsh Assembly-sponsored public body which aims to provide advice on medicines management and prescribing to the Welsh Government’s Minister for Health and Social Services in an effective, efficient and transparent manner.

All Wales Prescribing Advisory Group (AWPAG)

AWPAG is a subgroup of AWMSG. AWPAG advises the All Wales Medicines Strategy Group (AWMSG) on strategic developments in prescribing and medicines management to promote the safe and effective use of medicines in Wales.

The main functions of the group:

  • Develop and implement strategies that promote safe, rational, cost-effective prescribing
  • Monitor prescribing patterns and develop appropriate indicators
  • Advise on appropriate training, education and professional development for those persons employed in providing prescribing advice
  • Advise on the impact of developments that involve the use of medicines
  • Working in collaboration with other groups and organisations to promote the best use of medicines for patients

All Wales Therapeutics & Toxicology Centre (AWTTC)

The AWTTC provides secretariat, pharmaceutical, clinical and health economics support to AWMSG and its subgroups.


Arzneimittelmarkt-Neuordnungsgesetz – AMNOG is the Act on the Reform of the Market for Medicinal Products. AMNOG aims to limit the cost of pharmaceuticals by the statutory health insurance funds.


Advanced Manufacturing Supply Chain Initiative

Annual Financial Return (AFR)

AFR documents provide governmental bodies information regarding your financial returns in the previous year.

The AFR should cover, on a consolidated basis, the company and its subsidiaries, and should include business done through branches or divisions.


Agence Nationale de Sécurité du Médicament et des Produits de Santé – the ANSM is a public administrative body which acts on behalf of the French Government to ensure patient safety by conducting assessments and acting as a decision-making body in the field of the regulation of health products.


See ‘Technology appraisal (single and multiple)’.

Appraisal Committee

An independent committee that develops NICE’s guidance on using drugs or treatments in the NHS (called technology appraisal guidance). It is made up of healthcare professionals and NHS managers, researchers, lay representatives, and people who work for drug companies and medical equipment manufacturers.

Appraisal Consultation Document (ACD)

The ACD sets out the Appraisal Committee’s provisional recommendations to NICE on how the technology should be used in the NHS in England.

It is the Appraisal Committee’s draft guidance on using a drug (or group of drugs) or treatment in the NHS (called technology appraisal guidance). The manufacturer and organisations who have been invited as consultees and commentators can comment on this draft guidance.

The ACD will include any restrictions in the event that a restrictive recommendation has been made by NICE.

Appraisal of Evidence

Formal assessment of the quality of research evidence and its relevance to the topic being considered. It is assessed according to predetermined criteria.

Area Drugs and Therapeutics Committee (ADTC)

Committees responsible for providing advice to the regional NHS boards in Scotland on the use of medicines to meet the needs of the patients in that health board area. There are 14 regional health boards in Scotland.

Area Prescribing Committee (APC)

A local formulary decision-making group that is based in primary care.


A diagnostic test to measure the concentration or level of a particular analytic.

Assessment Group

An independent assessment group commissioned by the NHS Research and Development Health Technology Assessment (HTA) programme to produce an independent review of the evidence for technologies being appraised within the multiple technology appraisal (MTA) process.

Assessment Protocol

The assessment protocol is derived from the scope of the appraisal, taking into account consultation responses to the draft scope and comments from organisations attending the scoping workshop. It forms the basis of the assessment report during an appraisal following the MTA process.

Assessment Report

A critical review of the clinical and cost effectiveness of a health technology or technologies being appraised within the multiple technology appraisal (MTA) process. It is prepared by the Assessment Group. To prepare the report, the Assessment Group carries out a review of the published literature and the submissions from manufacturers and sponsors.

Association of British HealthTech Industries (ABHI)

The ABHI is an industry association for the medical technology sector in the UK.

Association of the British Pharmaceutical Industry (ABPI)

The ABPI is the trade association for more than 90 companies in the UK producing prescription medicines for human use.


ASTUTE (Advanced Sustainable Manufacturing Technologies) was a five-year (2010-2015) EU Funded Project part-funded by the European Regional Development Fund (ERDF) through the Welsh Government. The project provided resources, facilities, advice and guidance to the Welsh manufacturing sector and has now been superseded by ASTUTE 2020.

Average Selling Price (ASP)

The average net price – usually in a country.


British Bankers’ Association


The Business Growth Fund (BGF) is an investment company, providing patient capital for small and medium-sized enterprises in the United Kingdom and Ireland.

BioIndustry Association (BIA)

The UK BioIndustry Association (BIA) is the trade association for innovative enterprises involved in UK bioscience. The BIA works to further the interests of members and the industry – nationally and internationally.


A biosimilar is a biological pharmaceutical product that is highly similar to and has no clinically meaningful differences from an existing licensed reference product.


Blueteq is a web-based clinical decision support system that was implemented in 2015/16 as NHS England’s standard electronic contractual prior approval system, covering a range of high-cost drugs excluded from the drug tariff.


Biomedical Research Centre

British In Vitro Diagnostics Association (BIVDA)

The national industry association for companies with major involvement and interest in the in vitro diagnostics (IVD) industry.

British National Formulary (BNF)

Publications which evaluate clinical evidence from diverse sources with information validated by a network of clinical experts. BNF Publications reflect current best practice as well as legal and professional guidelines relating to the uses of medicines.


Biomedical Research Unit

Budget Impact Model (BIM)

A budget impact model measures the net cumulative cost of treatment with a particular therapy for a given number of patients in a specific population.

Budget Impact Test (BIT)

A Budget Impact Test is used by NICE to assess the financial impact a technology over the first 3 years of its use in the NHS.

Business, Innovation & Skills (BIS)

The Department for Business, Innovation & Skills (BIS) is the department for economic growth. The department invests in skills and education to promote trade, boost innovation and help people to start and grow a business. BIS also protects consumers and reduces the impact of regulation.

Cancer Drugs Fund (CDF)

The CDF is a centralised process that offers a route to funding in England for cancer medicines.

Care Pathway

Care pathways are sometimes described as ‘integrated care pathways’ (ICP) and are a tool and a concept, that embed guidelines, protocols and locally agreed, evidence-based, patient-centred, best practice, into everyday use for the individual patient. An ICP aims to have:

  • The right people,
  • Doing the right things,
  • In the right order,
  • At the right time,
  • In the right place,
  • With the right outcome,
  • All with attention to the patient experience

Care Programme Approach (CPA)

The care programme approach is a systematic assessment of a patient’s health and social care needs, a care plan, a key worker and a regular review of progress.


In this guide the term ‘carer’ refers to a person who provides unpaid care by looking after a relative, friend or partner who needs support because of ill health, frailty or disability.

CE mark

A CE mark is the manufacturer’s declaration that the product meets the health, safety and environmental protection requirements of the applicable European Standards. The actual words signified by “CE” have been disputed. It is often taken to be an abbreviation of Conformité Européenne, meaning “European Conformity”.


Cell and Gene Therapy (C&GT)

Please see Advanced Therapy Medicinal Products (ATMP).

Centre Director

The Director of the Centre for Health Technology Evaluation is responsible for the delivery of the technology appraisal programme. The Director is also responsible for ensuring that appraisals are conducted in accordance with the published appraisal process and methodology.

Centre for Guidelines (CfG)

The centre at NICE that is responsible for producing guidelines on public health topics. These are recommendations, based on the best available evidence, about preventing ill health and promoting good health. The guidelines are developed by independent Public Health Advisory Committees.

Centre for Health Technology Evaluation (CHTE)

The centre at NICE that is responsible for producing technology appraisals, and interventional procedure, medical technology and diagnostics guidance. The guidance is developed by independent committees.

Technology appraisal guidance makes recommendations on the use of new and existing technologies in the NHS. Interventional procedure guidance evaluates the safety and efficacy of procedures used for diagnosis or treatment. The Medical Technologies Programme evaluates innovative medical technologies. The Diagnostics Assessment Programme evaluates diagnostic technologies.

Citizens Council

A group of 30 people drawn from all walks of life who bring the public’s views to NICE decision-making. The Citizens Council tackles challenging questions about values, such as fairness and need.

Clinical Commissioning Group (CCG)

Clinically-led statutory NHS bodies responsible for the planning and commissioning of health care services for their local area. CCGs were created in 2012 by the Health and Social Care Act (H&SC) and replaced the Primary Care Trusts in 2013.

Clinical Effectiveness

The extent to which an intervention produces an overall health benefit, taking into account beneficial and adverse effects, in routine clinical practice. It is not the same as efficacy.

Clinical Effectiveness Team (CET)

A small national team which procures high quality information that supports the development of commissioning policies.

Clinical Governance

A system through which NHS organisations are accountable for continuously improving the quality of their services and safeguarding high standards of care, by creating an environment in which clinical excellence will flourish.

Clinical Investigation

Any systematic investigation or study in human subjects, undertaken to verify the safety and performance of a device under normal conditions of use.

Clinical Investigation Plan

A document that includes detailed information on the rationale, aims and objectives, design and proposed analyses, methodology, and conduct of the clinical investigation.

Clinical Investigator

The person responsible for the conduct of a clinical investigation and who takes the responsibility for the health and safety of the subjects involved.

Clinical Priorities Advisory Group (CPAG)

Advisory group that make recommendations on NHS England’s approach to commissioning services, treatments and technologies.

Clinical Reference Group (CRG)

CRGs are bring together groups of clinicians, commissioners, public health experts, patients and carers. There are tasked with the overall responsibility of ensuring that service specifications and clinical commissioning policies are delivered on time and to a high-quality standard. They use their specific knowledge and expertise to advise NHS England on the best ways that specialised services should be provided. CRGs will provide advice on the development of service specifications, commissioning policies, identifying innovation and improving quality.

CRGs are based around the six National Programmes of Care (NPoC), establishing to cover the full range of specialised services defined within NHS England’s mandate.

Clinical Specialist

In technology appraisals, clinical specialists act as expert witnesses to the Appraisal Committee. They are selected on the basis of specialist expertise and personal knowledge of the technology and/or other treatments for the condition. They provide a view of the technology within current clinical practice, and insights not typically available in the published literature.

Clinically Critically Urgent (CCU)

Clinically critically urgent (CCU) procedures are used to consider funding requests for specialised services (drugs, devices and other clinical interventions) that are not routinely funded by the NHS, made on behalf of individuals who do not meet the criteria for an Individual Funding Request (IFR) and who present with critically clinically urgent circumstances.

Clinician and Patient Involvement Group (CAPIG)

CAPIG is part of the All Wales Medicines Strategy Group (AWMSG) health technology appraisal (HTA) process for new orphan/ultra-orphan medicines and medicines used to treat a rare disease. The aim of CAPIG is to identify and discuss in more detail any additional benefits of the medicine from both a clinician and patient perspective. The additional information gathered for CAPIG (the CAPIG report) will be presented to AWMSG and this will help AWMSG make a decision that takes greater account of the patient and clinician perspective.


An organisation that engages in the appraisal process but is not asked to prepare a submission dossier. Commentators are invited to comment on the draft scope document, the assessment report and the appraisal consultation document (ACD). They receive the final appraisal determination (FAD) for information only. These organisations are manufacturers of comparator technologies, Healthcare Improvement Scotland (HIS), the relevant National Collaborating Centre, related research groups, and other groups when appropriate.

Commercial In Confidence

See ‘In Confidence Material’.

Commercial Medicines Unit (CMU)

The CMU team work in partnership with the people who buy pharmaceuticals for hospitals across the NHS in England. In particular, it works with NHS pharmacists and suppliers to gather and analyse the money spent on secondary care (hospital) medicines. CMU works on behalf of both the Department of Health and Social Care (DHSC)  and the NHS.


The process used by health services and local authorities to: identify the need for local services; assess this need against the services and resources available from public, private and voluntary organisations; decide priorities; and set up contracts and service agreements to buy services. As part of the commissioning process, services are regularly evaluated.

Commissioning Support Programme (CSP)

Commissioning Support Programme (CSP) assists in the development of NHS England’s specialised clinical commissioning policies for licensed or soon-to-be licensed medicines. CSP reviews the published clinical evidence for the topic, summarises the evidence and assesses the impact of commissioning the product in the NHS.


Committee for Advanced Therapies (CAT)

The Committee for Advanced Therapies is part of the European Medicines Agency (EMA). It is the committee responsible for assessing the quality, safety and efficacy of Advanced Therapy Medicinal Products (ATMPs), such as gene and cell therapies.

Committee for Economic and Public Health Assessment (CEESP)

A specialist committee within HAS for the economical assessment of drugs, medical devices and care strategies. They issue public health recommendations and technology appraisals based on clinical and economic evidence as well as on other domains (e.g. ethics, organisation).

Committee for Medicinal Products for Human Use (CHMP)

The committee responsible for preparing the Agency’s opinions on all questions concerning medicines for human use, in accordance with Regulation (EC) No 726/2004. The CHMP plays a vital role in the marketing procedures for medicines in the EU and publishes a European public assessment report (EPAR) for every centrally authorised medicine that is granted market authorisation.

Committee for Medicinal Products for Veterinary Use (CVMP)

The committee that is responsible for preparing the Agency’s opinions on all questions concerning veterinary medicines. The CVMP plays a vital role in the marketing procedures for medicines in the European Union.


Committee Papers

The committee papers that are issued and published with an appraisal consultation document (ACD) or a final appraisal document (FAD) include all of the evidence seen by the Appraisal Committee. It is made up of the ERG report, written submissions, and the personal statements of patient experts and clinical specialists, as well as comments received on the ERG report. For second and subsequent committee meetings they will also include consultation comments and responses.


More than one medical/psychiatric condition present.


Similarity of groups in terms of characteristics likely to affect study results (such as health status or age).


The standard intervention against which the intervention under appraisal is compared. The comparator can be no intervention, for example best supportive care.

Confidentiality Disclosure Agreement (CDA/NDA)

A Confidentiality Disclosure Agreement (CDA, also known as non-disclosure agreement; NDA) is a legal contract between at least two parties that outlines confidential material, knowledge, or information that the parties wish to share with one another for certain purposes, but wish to restrict access to or by third parties.

CONSORT Statement (Consolidated Standards of Reporting Trials)

The CONSORT Statement is a set of evidence-based recommendations for improving the reporting of randomised controlled trials. A flow diagram and checklist allow readers to understand how to conduct a study and assess the validity of the results.

Consortia for Improving Medicine with Innovation & Technology (CIMIT)

CIMIT is a network of academic and medical institutions partnering with industry and government in the USA. The aim is to promote collaboration among clinicians, technologists, and entrepreneurs to accelerate innovation.


The period during guidance development when stakeholders or interested members of the public can comment on draft guidance. For guidelines and technology appraisals, there is also a consultation on the draft scope.


An organisation that participates in a technology appraisal. Consultees can comment on the draft scope, the Assessment Report and the appraisal consultation document (ACD) during the consultation process. Consultee organisations can nominate clinical specialists, commissioning experts and patient experts to present their personal views to the Appraisal Committee. All consultees are given the opportunity to appeal against the final appraisal determination (FAD).

Corporate Pharmaceutical Unit (CPU)

The HSE Corporate Pharmaceutical Unit (CPU) is the interface between the HSE and the Pharmaceutical Industry in relation to medicine pricing and reimbursement applications and the operation of the national pricing framework agreements.

Cost Effectiveness

How well a technology works in relation to how much it costs.

Cost-Benefit Analysis

One of the tools used to carry out an economic evaluation. The costs and benefits are measured using the same monetary units (for example, pounds sterling) to see whether the benefits exceed the costs.

Cost-Consequence Analysis

One of the tools used to carry out an economic evaluation. This compares the costs (such as treatment and hospital care) and the consequences (such as health outcomes) of a test or treatment with a suitable alternative. Unlike cost-benefit analysis or cost-effectiveness analysis, it does not attempt to summarise outcomes in a single measure (such as the quality-adjusted life year) or in financial terms. Instead, outcomes are shown in their natural units (some of which may be monetary) and it is left to decision-makers to determine whether, overall, the treatment is worth carrying out.

Cost-Effectiveness Analysis

Cost-effectiveness analysis assesses the cost of achieving a benefit by different means. The benefits are expressed in non-monetary terms related to health, such as symptom-free days, heart attacks avoided, deaths avoided or life years gained (that is, the number of years by which life is extended as a result of the intervention).

Cost-Minimisation Analysis

One of the tools used to carry out an economic evaluation. Cost-minimisation analysis compares the costs of different interventions that provide the same benefits. If they are equally effective, only the costs are compared and the cheapest intervention will provide the best value for money. In practice, there are relatively few cost-minimisation analyses because it is rare for 2 healthcare interventions to provide exactly the same benefits.

Cost-Utility Analysis

One of the tools used to carry out an economic evaluation. The benefits are assessed in terms of both quality and duration of life, and expressed as quality-adjusted life years (QALYs).


Clinical Practice Research Datalink


Clinical Research Centre


Commissioning Support Documents.


Devolved Administration


Delivering Assisted Living Lifestyle at Scale


Diagnostics Assessment Programme

Decision Problem

The decision problem describes the proposed approach to be taken in the sponsor’s submission of evidence to answer the question in the scope. This includes the population, intervention, comparator(s), outcomes, cost analysis, subgroup analysis and any special considerations.

Decision Support Unit (DSU)

The Decision Support Unit helps the technical team at NICE to meet the information needs of the Appraisal Committee. This is achieved by providing support, as required, to the technical team and the Evidence Review Group. The objective of the Decision Support Unit is to enhance the delivery of robust information to support Appraisal Committee decision-making. The Decision Support Unit is a multidisciplinary team, expert in methods of health technology appraisal and capable of providing advice and high-quality analyses to decision-makers within very tight deadlines.

Decision-Analytic Model

A model of how decisions are or should be made. This could be one of several models or techniques used to help people to make better decisions (for example, when considering the trade-off between costs, benefits and harms of diagnostic tests or interventions).

Department for International Trade (DIT)

The department for international trade (DIT) is a UK Government department working with businesses based in the United Kingdom to assist their success in international markets, and with overseas investors looking to the UK as an investment destination.

Formerly known as UKTI.

Department of Health (DoH), Northern Ireland

A devolved Northern Irish government department in the Northern Ireland Executive, with the aim to improve the health and social well-being of the people of Northern Ireland.

Department of Health and Social Care (DHSC)

The Department of Health and Social Care (DHSC) is responsible for standards of healthcare in the UK, including the NHS. The Department sets the strategic framework for adult social care and influences local authority spending on social care. The Department is also responsible for promoting and protecting the public’s health, taking the lead on issues like environmental hazards to health, infectious diseases, health promotion and education, the safety of medicines, and ethical issues.

Detailed Advice Document (DAD)

A detailed advice document is the document produced by the HTA body (e.g. NICE, SMC) providing final advice on whether a medicine is accepted for routine use, not recommended for use or accepted for restricted use.

Directorate of Social Security (DSS)

One of the main areas within the French Ministry of Health which elaborates the Social Security policy (Sickness Fund, pension, family). It is also attached to the Ministry of Finance.


Costs and perhaps benefits incurred today have a higher value than costs and benefits occurring in the future. Discounting health benefits reflects individual preference for benefits to be experienced in the present rather than the future. Discounting costs reflects individual preference for costs to be experienced in the future rather than the present.


The Directorate for Research, Analysis, Evaluation and Statistics within the Ministry of Health in France.

Drugs and Therapeutics Committee (D&TC)

A local formulary decision-making groups that is hospital (secondary care) based.

Early Access to Medicines Scheme (EAMS)

EAMS is a system which aims to provide patients that have seriously debilitating or life-threatening conditions, access to medicines which do not yet possess marketing authorisation when there is a clear unmet medical need.

Economic Committee for Health Products (CEPS)

The Comité Economique des Produits de Santé (CEPS) fixes the medicine price after negotiation with the medicine company. It is an inter-ministerial body under the joint authority of the ministries for Health, Social Security and Economy.

Economic Evaluation

An economic evaluation is used to assess the cost effectiveness of healthcare interventions (that is, to compare the costs and benefits of a healthcare intervention to assess whether it is worth doing). The aim of an economic evaluation is to maximise the level of benefits – health effects – relative to the resources available. It should be used to inform and support the decision-making process; it is not supposed to replace the judgement of healthcare professionals.

There are several types of economic evaluation: cost-benefit analysis, cost-consequence analysis, cost-effectiveness analysis, cost-minimisation analysis and cost-utility analysis. They use similar methods to define and evaluate costs but differ in the way they estimate the benefits of a particular drug, programme or intervention.

Economic Model

An explicit mathematical framework that is used to represent clinical decision problems. It incorporates evidence from a variety of sources so that the costs and health outcomes can be estimated.

Economic Modelling

A way to estimate the costs and effects of an intervention over periods of time on patient groups not covered in a clinical trial or other research.


Enterprise Investment Scheme

Electronic Health Record (EHR)

The term EHR is used to describe the record of patient’s overall health and healthcare. It combines information about patient contacts with primary health care and information associated with the elements of care held in EPRs.

Electronic Patient Record (EPR)

A record of a patient’s personal details (name, date of birth, etc.) their diagnosis or condition and details about the treatment/assessments undertaken by a clinician. Typically, it covers the care provided, mainly by one organisation.

Eligible Patients

Those patients who fit the criteria within the label/Summary of Product Characteristics (SmPC) and also the criteria and restrictions of the national or regional HTAs and other access authorities.

Enterprise Ireland

Enterprise Ireland is the government organisation responsible for the development of Irish-owned businesses and securing new export sales in global markets.


The Engineering and Physical Sciences Research Council (EPSRC) is the UK’s main agency for funding research in engineering and the physical sciences.

Ethical Medicines Industry Group (EMIG)

EMIG is a UK research-based trade association that represents the interests of small to medium-sized Pharmaceutical, Biotech and Medtech companies (SMEs).

EUDAMED: European Database on Medical Devices

EUDAMED will be an information system for exchanging legal information related to the application of European Union Directives on medical devices between the European Commission’s Enterprise and Industry Directorate General and the Competent Authorities in the European Union Member States. Its legal basis is laid down in Directives 90/385/EEC, 93/42/EEC, 98/79/EC and 2000/70/EC.

European Commission (EC)

The European Commission is the EU’s executive body. It represents the interests of the European Union as a whole and not individual countries.

The Commission’s main roles are to:

  • propose legislation which is then adopted by the co-legislators, the European Parliament and the Council of Ministers
  • enforce European law (where necessary with the help of the Court of Justice of the EU)
  • set a objectives and priorities for action, outlined yearly in the Commission Work Programme and work towards delivering them
  • manage and implement EU policies and the budget
  • represent the Union outside Europe (e.g. negotiating trade agreements between the EU and other countries)

European Economic Area (EEA)

Established on the 1st January 1994, the EEA includes the countries of the EU (European Union) plus Iceland, Liechtenstein and Norway.

European Medicines Agency (EMA)

The EMA is a decentralised agency of the European Union responsible for the scientific evaluation of medicines developed by pharmaceutical companies for use in the European Union.

European Public Assessment Report (EPAR)

A published report by the European Medicines Agency (EMA) with detailed information on medicines assessed by the Committee for Medicinal Products for Human Use (CHMP) and Committee for Medicinal Products for Veterinary Use (CVMP) for every human or veterinary medicine application that has been granted or refused a marketing authorisation.


An assessment of an intervention (for example, a treatment, service, project, or programme) to see whether it achieves its aims.


Information on which a decision or guidance is based. Evidence is obtained from a range of sources, including randomised controlled trials, observational studies and expert opinion (of healthcare and other professionals and/or patients).

Evidence Review Group (ERG)

An independent assessment group commissioned by the NHS Research and Development Health Technology Assessment (HTA) programme to produce an independent assessment of the evidence submitted by the manufacturer or sponsor of a technology being appraised within the single technology appraisal (STA) process.

Evidence Review Group Report

A critical assessment of the evidence submitted by the manufacturer of a technology being appraised within the single technology appraisal (STA) process. It is prepared by the Evidence Review Group.

Evidence Statement

A brief summary of the key findings from a review of evidence that has been used as the basis for a recommendation in a guideline.

External Launch

The event/activities to mark the launch of the product to customers.

External Reference Pricing

External reference pricing is a method used by some countries to set drug prices based on the prices of medicines in other countries. For example, Ireland has a basket of 9 external reference states that it uses to influence the prices set for its pharmaceutical industry.

Final Appraisal Determination (FAD)

The FAD sets out the Appraisal Committee’s final recommendations to NICE on how the technology should be used in the NHS in England.

First Commercial Availability

Date at which the first commercial stock is available to patients for prescription and dispensing, regardless of price and reimbursement status (can also be available via (paid) named patient programs using commercial pack (e.g. Can be made available in Switzerland before Swissmedic approves at time of launch in Germany).

French National Authority for Health (HAS)

Haute Autorité de Santé (HAS) is an independent public scientific authority with financial autonomy. Its key purpose is to improve the quality of patient care and to guarantee equity within the healthcare system. It does this through the:

  • assessment of drugs and medical devices
  • certification of healthcare organisations and accreditations of doctors
  • publication of guidelines (good practices, public health)

Gemeinsamer Bundesausschuss (G-BA)

Gemeinsamer Bundesausschuss – The Joint Federal Committee (G-BA) is authorised to set limitations on coverage. It is the highest decision-making body of the joint self-government of a second function of the G-BA is the definition of drugs, which are subject to fixed prices.

General Inspectorate of Social Affairs (IGAS)

L’Inspection générale des affaires sociales (IGAS) is the centre which controls, audits and evaluates structures and policies within the Ministry of Health in France.


Association of Statutory Health Insurance Funds – being the central association of the health insurance funds at federal level in accordance with section 217 a of Book V of the German Social Code (SGB V).


The only class of medicines in the existing market that have been called by G-BA for assessment while this was possible.

Greater Manchester Medicines Management Group (GMMMG)

The GMMMG is a coordinating group (consisting of GPs, pharmacists and other key healthcare professionals) for decision making around medicines and in particular high cost medicines for Greater Manchester. It also has a role in performance monitoring of health economies prescribing.

Gross Sales

The numbers of units sold x price before discounts.

Guidance Executive

A team comprising the Executive Directors and Centre Directors at NICE who are responsible for approving the final appraisal determination before publication.

Hazard Ratio

A measure of effect produced by a time-to-event survival analysis. This represents the increased instantaneous rate with which one group is likely to experience the outcome of interest.

Health and Safety Executive (HSE)

The UK body responsible for regulation and enforcement of workplace health, safety and welfare through the Health and Safety at Work etc. Act 1974.

Health and Social Care (HSC/H&SC)

In the UK, Health and Social Care (HSC or H&SC) is a term that relates to services that are available from health and social care providers. It is a generic term used to refer to the whole of the healthcare provision infrastructure, public and private sector.

Health Innovation Challenge Fund

The Health Innovation Challenge Fund was positioned as a translational funding scheme to accelerate the clinical application of projects that are well advanced along the development pathway.

Health Products Regulatory Authority (HPRA)

Formerly known as the Irish Medicines Board (IMB), the regulatory body in Ireland whose role it is to protect and enhance public and animal health by regulating medicines, medical devices and other health products.

Health Technology

Any method used by those working in health services to promote health, prevent and treat disease, and improve rehabilitation and long-term care. Technologies in this context are not confined to new drugs or medical technologies.

Health Technology Assessment (HTA)

The systematic evaluation of properties, effects, and/or impacts of health technology. It is a multidisciplinary process to evaluate the social, economic, organisational and ethical issues of a health intervention or health technology. The main purpose of conducting an assessment is to inform a policy decision making for a drug, medical device or clinical/surgical procedure.

Health-Related Quality of Life

A combination of a person’s physical, mental and social wellbeing.

Healthcare Improvement Scotland (HIS)

The national healthcare improvement organisation for Scotland. The SMC is part of HIS.

HIS has a key role in supporting healthcare providers to make sure that their services meet these expectations and continually improve the healthcare the people of Scotland receive.

HealthTech Connect

HealthTech Connect is a secure online system for identifying and supporting health technologies (including devices, diagnostics, and digital) as they move from inception to adoption in the UK health and care system.

Highly Specialised Technology (HST)

HST evaluations are recommendations on the use of new and existing highly specialised medicines and treatments within the NHS in England. The HST programme only considers drugs for very rare conditions and notify the DHSC of key, new and emerging healthcare technologies that might need to be referred to NICE.

Horizon Scanning

The process of identifying new medicines or new uses of existing medicines that are expected to receive marketing authorisation from the Medicines and Healthcare products Regulatory Authority (MHRA) or the European Medicines Agency (EMA) in the near future and estimating their potential impact on patient care.

Hospital Episode Statistics (HES)

Hospital Episode Statistics (HES) is a data warehouse containing details of all admissions, outpatient appointments and A and E attendances at NHS hospitals in England.


Health and Social Care Research and Development


Health and Social Care Information Centre

Implantable Device

Any device which is intended to be totally introduced into the human body, by surgical intervention and which is intended to remain in place after the procedure. Any device intended to be partially introduced into the human body through surgical intervention and intended to remain in place after the procedure for at least thirty days is also considered an implantable device.

In Confidence Material

Information (for example, the findings of a research project) defined as ‘confidential’ because its public disclosure could have an impact on the commercial interests of a particular company or the academic interests of a research or professional organisation, or the policy interests of government.

In-Market Sales

The sales in a specific market less Parallel Trade.

Incremental Cost-Effectiveness Ratio (ICER)

The ratio of the difference in the mean costs of a technology compared with the next best alternative to the differences in the mean outcomes.


The defined use of a technology as licensed by the European Medicines Agency (EMA) or the European Commission as well as specific bodies in each country such as the Medicines and Healthcare Products Regulatory Agency (MHRA) in the UK.

Individual Funding Requests (IFR/IPFR/IPTR)

An individual funding request is a special request that can be made by your clinician (doctor or other health professional) if they believe that a particular treatment or service that is not routinely offered by the NHS is the best treatment for you, given your individual clinical circumstances.

Internal Launch

The event to mark the launch for company employees.

Invasive Device

A device which, in whole or in part, penetrates inside the body, either through a body orifice or through the surface of the body.


The Institute for Quality and Efficiency in Health Care (IQWiG) is a German agency responsible for assessing the quality and efficiency of medical treatments, including drugs, non-drug interventions, diagnostic and screening methods, and treatment and disease management.


Integrated Research Application System


International Society for Pharmacoeconomics and Outcomes Research (ISPOR), an international organisation promoting the science of pharmacoeconomics and health outcomes research.

Joint Committee on Vaccinations and Immunisations (JCVI)

The Joint Committee on Vaccination and Immunisation (JCVI) advises UK health departments on matters relating to communicable diseases which are preventable or potentially preventable through immunisation.

The JCVI also makes recommendations to the British government concerning vaccination schedules and vaccine safety.


Knowledge Transfer Network


Knowledge Transfer Partnership

Lead Team

Members of the Appraisal Committee asked to introduce individual appraisals at committee meetings.

List Price

The published price – in an official document/website per market.

Local Authority (LA)

Some therapy areas are managed partly by health authorities (e.g. CCGs, NHSE) and partly by local council authorities e.g. public health is largely funded through local authorities.

Local Health Boards (LHB)

An administrative unit within the National Health Service in Wales. There are 7 LHBs which plan, secure and deliver healthcare services in their areas, replacing the 22 LHBs and the 7 NHS Trusts.


Life Science Investment Organisation

Managed Access Agreement (MAA)

A Managed Access Agreement is an alternative name for Managed Entry Agreement (MEA). An MAA reduces the budget impact of a product by restricting use, including payment by results, or offering some kind of discount.

Managed Entry Agreements (MEA)

MEAs are schemes designed to reduce these costs. MEAs have been used by decision makers to recommend technologies under two broad conditions:

  1. That the price of the technology be reduced and/or
  2. That further research be conducted. Both conditions have the aim of reducing risk and decision uncertainty

Market Exclusivity

Market exclusivity times vary depending on the nature of the product but are generally 5 years for new chemical entities (NCEs) and 10 years for orphan products. During this period of market exclusivity, other industry operators can not enter the market with a similar product for the same therapeutic indication.

Marketing Authorisation

An authorisation to market a medicinal product from the European Medicines Agency (EMA) or the European Commission or from additional bodies specific to each countries such as the Medicines and Healthcare Products Regulatory Agency (MHRA) in the UK.

Marketing Authorisation Holder (MAH)

The MAH is the company in whose name the marketing authorisation has been granted. This party has responsibility for all aspects of the product, including quality and compliance with the conditions of the marketing authorisation.


Manufacturing Advisory Service

Master Services Agreement (MSA)

The master services agreement (MSA) is a document agreed between two parties that sets out standard terms that apply to all the transactions entered into between those parties. Each time that a transaction is entered into, the terms of the MSA do not need to be re-negotiated and apply automatically.

Medical Device Liaison Officer (MDLO)

This person’s primary role is to encourage the effective reporting of adverse incidents.

Medical Devices

All products, except medicines, used in healthcare to diagnose, prevent, monitor or treat illness or disability. For example, a device might be a pacemaker, knee replacement, X-ray or blood pressure monitor.

Medical Devices Directive (MDD)

The Medical Device Directive is intended to harmonise the laws relating to medical devices within the European Union.

Medical Research Council (MRC)

The Medical Research Council is a publicly funded government agency responsible for co-ordinating and funding medical research in the United Kingdom.

Medical Technologies Advisory Committee

An independent committee with 2 roles: selecting medical technologies for evaluation by other NICE guidance programmes and developing medical technologies guidance itself.

Medical Technologies Evaluation Programme (MTEP)

MTEP is a programme to identify medical technologies that could offer benefits to patient or the NHS. Manufacturers notify NICE about possible topics. The Medical Technologies Advisory Committee selects products for evaluation. It may carry out the evaluation itself or refer the topic to be evaluated by another NICE programme – usually technology appraisals, interventional procedures, diagnostics, and sometimes guidelines.

Medical Technologies Guidance

Guidance produced by the Medical Technologies Advisory Committee on technologies that it evaluates. Medical technologies may also be evaluated by other NICE programmes, and usually result in diagnostics guidance or technology appraisal guidance.

Medicines and Healthcare Products Regulatory Agency (MHRA)

The Executive Agency of the Department of Health and Social Care (DHSC). It protects and promotes public health and patient safety by ensuring that medicines, healthcare products and medical equipment meet appropriate standards of safety, quality, performance and effectiveness, and are used safely.

Medicines Evaluation Committee (MEC)

A sub-group of the Area Prescribing Committee (APC) to conduct specific evaluation reports of a new medicine.

Medicines Optimisation Oversight Group (MOOG)

The Medicines Optimisation Oversight Group (MOOG) is responsible for the governance, oversight of RMOC processes and the new RMOC system to ensure consistency in operation and for ratifying the prioritised RMOC annual work programme.

Medicines Optimisation Priorities Panel (MOPP)

The Medicines Optimisation Priorities Panel (MOPP) determines the priority medicine optimisation topics which are to be addressed through the RMOCs.

Medtech Innovation Briefing (MIB)

MIBs help support NHS and social care commissioners and staff who are considering using new medical devices and other medical or diagnostic technologies. They include a description of the technology, how it’s used and its potential role in the treatment pathway.

A MIB also includes a review of relevant published evidence and the likely costs of using the technologies. They are designed to be fast, flexible and responsive to the need for information on innovative technologies.

Mental Health Trust (MHT)

A MHT provides health and social care services for people with mental health disorders in England.

Midlands Therapeutics Review and Advisory Committee (MTRAC)

MTRAC is an independent professional committee of prescribers and other key decision-makers in the use of medicines in primary care in the West Midlands region. It reviews selected pharmaceutical products to assess their clinical value, safety and suitability for use in primary care.

Multicentre Investigation

A clinical investigation, conducted according to a single clinical investigation plan, which takes place at different investigation sites.

Named Patient Programs (NPP)

Named patient programs (NPP) provide controlled, pre-approval access to drugs in response to requests by physicians on behalf of specific, or “named”, patients before those medicines are licensed in the patient’s home country.

Through these programs, patients are able to access drugs in late-stage clinical trials or approved in other countries for a genuine, unmet medical need, before those drugs have been licensed in the patient’s home country.

National Assembly for Wales

The National Assembly for Wales is the democratically elected body that represents the interests of Wales and its people, makes laws for Wales, and holds the Welsh Government to account.

National Centre for PharmacoEconomics (NCPE)

The mission of the National Centre for PharmacoEconomics (NCPE) is to facilitate healthcare decisions on the reimbursement of technologies, by applying clinical and scientific evidence in a systematic framework, in order to maximise population wellness.

The NCPE is the Irish health technology assessment (HTA) body, assessing evidence for comparative effectiveness and cost-effectiveness of technologies for use by patients in Ireland. This is done through assessment of evidence submitted by manufacturers and independent systematic review. The NCPE also undertake research to inform national guidelines for HTAs.

National Committee for the Assessment of Medical Devices and Health Technologies (CNEDiMTS)

One of the 6 specialist committees within the HAS responsible for the assessment of medical devices and professional practices.

National Health Service (NHS)

The NHS is the name commonly used to refer to the publicly funded healthcare systems of the UK.

National Hospitals Office (NHO)

National Hospitals Office (NHO) are responsible for the management and co-ordination of the acute hospital sector nationally in Ireland.

National Institute for Care and Excellence (NICE)

NICE are a public body of the Department of Health and Social Care (DHSC) in the UK which provides national guidance and advice to improve health and social care. NICE also develop guidance, standards and information on high quality health and social care.

National Institute for Health Research (NIHR)

Funded by the Department of Health and Social Care (DHSC), the NIHR aims to improve the health and wealth of the nation through research, driving faster research translation from bench to bedside for the benefit of patients and the economy.

National Institute for Health Research – Health Technology Assessment Programme (NIHR HTA)

The National Institute for Health Research – Health Technology Assessment (NIHR HTA) is part of the NIHR Evaluation, Trials and Studies Coordinating Centre (NETSCC) based at the University of Southampton. The NIHR HTA coordinates the Health Technology Assessment (HTA) Programme on behalf of the NIHR. The aim of the HTA Programme is to ensure that high-quality research information on the costs, effectiveness and broader impact of health technologies is produced in the most efficient way.

National Programmes of Care (NPoC)

National Programmes of Care are strategies which group together the prescribed (nationally agreed range of) specialised services. These strategies will enable the commissioning of services to be based on clear evidence and ensure that they are cost effective and patient focused.


The six NPoC’s are:


– Internal medicine – digestion, renal, hepatobiliary and circulatory system
– Cancer
– Mental health
– Trauma – traumatic injury, orthopaedics, head and neck and rehabilitation
– Women and children – women and children, congenital and inherited diseases
– Blood and infection – infection, immunity and haematology


National Endowment for Science, Technology and the Arts (Nesta) is an innovation foundation based in the UK. The organisation acts through a combination of programmes, investment, policy and research, and the formation of partnerships to promote innovation across a broad range of sectors.

Net Price

The locally negotiated price (often dictated through the P&R/HTA prices) after discounts (list price minus discounts incl. mandatory or negotiated government rebates etc.).

Net Price Ceiling and Floor

The net price maximum and minimum band for negotiations (internal reference point only).

Net Sales

The number of units sold multiplied by the net price.

New Drugs Committee (NDC)

Every medicine submitted to SMC is given initial consideration by the New Drugs Committee (NDC), a scientific sub-group who consider the clinical and economic evidence put forward by a company. The members of NDC are mostly healthcare professionals from area drug therapeutic committees (ADTCs). They make an initial recommendation on whether the medicine should be accepted for use in NHS Scotland or not. This recommendation is then presented at the SMC meeting. If the medicine is end of life, orphan or ultra-orphan and the NDC have not recommended it, then the medicine can be considered at a PACE meeting. The output of the PACE meeting is taken into consideration at the SMC meeting.

New Medicines Group (NMG)

NMG is a subgroup of the All Wales Medicines Strategy Group (AWMSG). Up to ten NMG meetings are scheduled per year, which are held in private. NMG considers the clinical and cost-effectiveness of a medicine, along with written evidence from the pharmaceutical company, clinical experts in the field and relevant patient organisation(s)/support group(s)/patient(s)/patient carer(s). NMG makes a preliminary recommendation to AWMSG in relation to each medicine undergoing appraisal.

NHS England (NHSE)

NHS England leads the NHS in England. It sets the priorities and direction of the NHS. It commissions the contracts for GPs, pharmacists, and dentists and supports CCGs.

NHS Scotland

NHS Scotland is the publicly funded healthcare system in Scotland. Health and social care policy and funding are the responsibility of the Health and Social Care Directorates of the Scottish Government.

NIHR i4i

National Institute for Health Research Invention for Innovation


National Institute for Social Care and Health Research


NIHR Office for Clinical Research Infrastructure

Notified Body

A notified body, in the European Union, is an entity that has been accredited by a Member State to assess whether a product to be placed on the market meets certain preordained standards.


NHS Research Scotland


NHS Research Scotland Permissions Coordinating Centre


Orphan Maintenance Assessment Report


L’Objectif national de dépenses d’assurance maladie (ONDAM) is the target for national health insurance expenditure in France.

Organisation for Economic Cooperation and Development (OECD)

The Organisation for Economic Cooperation and Development (OECD) is a group of 36 member countries that discuss and develop economic and social policy. OECD countries are democratic countries that support free market economies.


A term designated to rare diseases and drugs that treat such diseases. The prevalence of the condition must not exceed 5 in 10,000 in order to be classified as an orphan within the EU but may vary in other non-EU countries.


A measure of the possible results of a treatment with a preventive or therapeutic intervention. Outcome measures can be either intermediate or final end points.

Over-the-Counter (OTC)

OTC drugs are medicines sold directly to a consumer without a prescription, from a healthcare professional.

Palliative Therapy

To relieve the pain and treat a disease as far as possible, but not cure it completely.

Parallel Trade

Parallel trade imports a patented product from an EU Member States with low prices and then sold in higher-priced Member States where the patent holder also markets that product but without the authorisation of the patent holder.


Patents cover specific details such as the manufacturing methods. Patents expire 20 years from the date of filing and can be expired before drug approval, issued after drug approval and anywhere in between whereas market exclusivity is granted upon approval by the appropriate regulating body. Patents act as barriers to entry, discouraging generic companies from entering the market as they need to ensure that they do not infringe on any patents held by the initial manufacturer.

Patient Access (%)

The percentage of available ELIGIBLE patients who may be prescribed product.

Patient Access Scheme (PAS)

A scheme where an agreement is reached between a pharmaceutical company and the NHS in order to reduce the costs of a medicine and improve its cost-effectiveness. This can enable patients to receive access to cost-effective, innovative medicines.

Patient Access Scheme Assessment Group (PASAG)

The Patient Access Schemes (PAS) advisory group in Scotland. PASAG review and advise NHS Scotland on the feasibility of proposed PAS for implementation. It operates separately from the SMC to maintain the integrity and independence of the assessment process.

Patient Access Scheme Liaison Unit (PASLU)

PASLU is the Patient Access Schemes (PAS) advisory group in England. Part of the NICE Centre for Health Technology Evaluation that coordinates the review and evaluation of PAS proposals and produces guidance to the Department of Health and Social Care (DHSC).

Patient Access Scheme Wales Group (PASWG)

PASWG is the Patient Access Schemes (PAS) advisory group in Wales, which aids the reviewing process for PAS applications made to the All Wales Medicines Strategy Group (AWMSG) within the Health Technology Appraisal (HTA) process.

Patient and Clinical Engagement (PACE)

The PACE process gives patient groups and clinicians a stronger voice in SMC decision making for rare/orphan diseases. The main purpose of PACE is to gather detailed information which will allow a discussion on the benefits of a medicine, including how it can impact the quality of a patient’s life which may not be captured in within the conventional assessment process.

Patient Experts

Acts as an expert witness to the Appraisal Committee. Patient experts have used the technology either personally or as part of a representative group. They provide a view on the risks and benefits of the technology from personal experience as a patient or carer, and an understanding of the wider range of patient and/or carer views.

Peer Approved Clinical System (PACS)

Clinicians (on behalf of their patients) can ask a Peer Approved Clinical System (PACS) Tier Two Panel within their NHS board whether they can access a medicine that has not been recommended by the Scottish Medicines Consortium and is therefore not routinely available in the NHS in Scotland.

Pharmaceutical Price Regulation Scheme (PPRS)

The 2014 PPRS was a non-contractual scheme that was replaced on 1 January 2019 by the 2019 Voluntary Scheme for Branded Medicines Pricing and Access (Voluntary Scheme). The parties to this agreement were the Department of Health and Social Care (DHSC), acting on behalf of the health departments of England, Wales, Scotland and Northern Ireland, and the Association of the British Pharmaceutical Industry (ABPI). The purpose of the scheme was to ensure that safe and cost-effective medicines were available on the NHS in England.

Pharmacovigilance Risk Assessment Committee (PRAC)

PRAC is the committee at the European Medicines Agency (EMA) that is responsible for assessing and monitoring safety issues for human medicines.

PRAC’s recommendations are considered by the CHMP when it adopts opinions for centrally authorised medicines and referral procedures when it provides a recommendation on the use of a medicine in the Members States.

Policy Working Group (PWG)

The purpose of the Policy Working Group (PWG) is to educate national leaders, organisations and agencies on the shared values, priorities, recommendations and contributions to bettering healthcare.


Preliminary policy proposal.

Pre-P&R Patient Access

The availability of a drug to patients through compassionate use or (commercial) Named Patient Programs (e.g. in France via ATU or Switzerland).

Prescribed Specialised Services Advisory Group (PSSAG)

The PSSAG is an expert committee within the Department of Health and Social Care (DHSC) which advises when services are specialised and should be directly commissioned nationally by NHS England rather than locally by CCGs.

Prescription Only Medicine (POM)

Medicines which can only be sold to patients with a valid prescription.

Pricing & Reimbursement (P&R)

Process and decision on pricing and reimbursement by health insurances and/or governmental using HTAs. Critical step for us before drug can enter a market.

Pricing and Reimbursement (P&R) date

When the price (net price) has been agreed by the national body.

Primary Care

Primary care is the day-to-day healthcare given by a health care provider outside of hospitals. It is typically the first point of contact for and includes a range of services provided by GPs, nurses, health visitors, midwives and other healthcare professionals and allied health professionals such as dentists, pharmacists and opticians. It includes community clinics, health centres and walk-in centres.

Primary, Community and Continuing Care (PCCC)

Primary, Community and Continuing Care (PCCC) directorate are responsible for the management and delivery of non-hospital services in Ireland.

Private Payers

Privately paid by patient or private health insurance.

Promising Innovative Medicine (PIM)

The PIM designation provides an indication that a product may be eligible for the EAMS, based on early clinical data. Often, this PIM designation is issued after the MHRA has held a scientific meeting and this designation can be provided several years prior to the product being licensed.

Public Assessment Report (PAR)

A public assessment report is published by the MHRA if you receive a positive EAMS scientific opinion.

The Public Assessment Report will include:

  • how the product is used and how it works
  • summary of the key clinical studies
  • the risks and benefits of the product
  • the reason for the positive EAMS scientific opinion
  • any uncertainties
  • information about ongoing clinical studies
  • measures in place to monitor and manage risk

Public Health England (PHE)

Public Health England (PHE) are an executive agency that delivers services to protect the public’s health through a nationwide integrated health protection service, provides information and intelligence to support local public health services, and supports the public in making healthier choices.

Public Health Wales NHS Trust

Public Health Wales was established as an NHS Trust on 1 October 2009. The Trust incorporates the functions and services previously provided by the National Public Health Service for Wales, the Wales Centre for Health, the Welsh Cancer Intelligence and Surveillance Unit, and the Congenital Anomaly Register and Information Service for Wales. Its statutory functions cover a broad range of public health, health protection, screening, health intelligence and research services.

Public Involvement Programme (PIP)

The PIP is the team at NICE that supports and develops public involvement across NICE’s work programme. A PIP Public Involvement Adviser is assigned to each appraisal and supports patient and carer consultee organisations, their representatives, and individual patients or carers throughout the appraisal. The PIP public involvement adviser also supports the lay members of the Appraisal Committees and supplies the patient and carer group information for the ‘Information for the public’.

Public Payers

Governments, national sick funds or health insurances.

Quality Adjusted Life Year (QALY)

The quality life adjusted year (QALY) is a tool used to work out how much benefit a patient might get from a medicine in terms of the increase in the length of their life weighted according to how high the quality of the life is. A QALY of 1 is equivalent to one year of perfect health.


Research & Development

Rapid Evidence Review (RER)/Rapid Evidence Assessment (REA)

The rapid evidence review/assessment is a process that is faster and less in-depth than a full systematic review but more rigorous than ad hoc searching, it uses a combination of key informant interviews and targeted literature searches to produce a report in a few days or a few weeks.

Rare Disease Advisory Group (RDAG)

RDAG receives recommendations from CRGs and calls on evidence from professional bodies and patient groups, then makes recommendations to UK nations and CPAG on development and implementation of rare disease and specialised services strategy.

Real-World Evidence (RWE)

Real-world evidence provides significant insight into how a drug or drug class performs or is used in real-world medical settings.


If documents contain confidential information, it must be redacted. ‘Academic in confidence’ and ‘commercial in confidence’ information should be replaced with asterisks and then highlighted in black.

Regional Drugs and Therapeutics Centre (RDTC)

RDTC is a commissioned service that provides strategic prescribing support services to Clinical Commissioning Groups, other primary care organisations, and NHS Hospital Trusts in the North of England.

Regional Medicines Optimisation Committees (RMOCs)

Regional Medicines Optimisation Committees (RMOCs) provide advice and make recommendations on the optimal use of medicines for the benefit of patients and the NHS. They bring together decision makers and clinicians across the four regions of England, to share best practice, understand the evidence base, coordinate action and so reduce variation thus improving outcomes and value.


This is the brief the Department of Health and Social Care (DHSC) gives to NICE when it formally refers a technology for appraisal. Typically, the remit outlines the disease, the patients and the technologies that will be covered by the appraisal.


Regional Growth Fund

RMOC Coordinating Hub

The RMOC coordinating hub will be run by the NHS Specialist Pharmacy Service and will undertake the following key activities:

  • coordinating the RMOC prioritisation process
  • hosting and coordinating the work of MOPP
  • developing and publicising the RMOC work programme, informed by MOPP
  • implementing the agreed RMOC work programme including the scheduling and allocation of work to individual RMOCs
  • monitoring implementation of RMOC advice and guidance by local areas and reporting this to RMOCs
  • providing quarterly updates to MOOG on national implementation of advice and guidance issued by the RMOCs


Regional Selective Assistance

Sales Force Launch

Date at which the commercial facing organisation is fully active in the country, within compliance, post marketing authorisation (i.e. – time at which we consider promotional activities to occur) – date of physical launch (not only readiness).


Provides a detailed framework for the appraisal and defines the disease, the patients and the technologies that will be covered by the appraisal. The questions the appraisal aims to address are also part of the scope.

Scottish Antimicrobial Prescribing Group (SAPG)

The Scottish Antimicrobial Prescribing Group (SAPG) delivers a national framework for improving the quality of antimicrobial prescribing in Scotland.

Scottish Intercollegiate Guidelines Network (SIGN)

SIGN provides evidence-based guidance on the diagnosis and management of specific conditions for the NHS in Scotland.

Scottish Medicines Consortium (SMC)

A consortium of stakeholders from NHS Boards and Area Drug and Therapeutic Committees (ADTCs) with representation derived from across NHS Scotland. The SMC provides advice to all NHS Boards and their ADTCs about the status of all newly licensed medicines, all new formulations of existing medicines and any major new indications for established products. All new products must undergo an SMC evaluation within 3 months of launch.

Scottish Patient Safety Programme (SPSP)

The SPSP is a national plan that aims to improve the safety and reliability of healthcare and reduce harm whenever care is delivered.

Secondary Care

Secondary care is healthcare provided in hospitals. It includes accident and emergency departments, outpatient departments, antenatal services, genitourinary medicine and sexual health clinics.


Seed Enterprise Investment Scheme


Scottish Health Technologies Group


Scottish Manufacturing Advisory Service


Small and medium-sized enterprises.

Social Code Book V (SGB V)

German social code book, this section specialises in Health insurance.

Social Security Financing Act (LFSS)

The act set by the Ministry of Health in France for the general framework for social security spending and a national target ceiling for health insurance expenditure (ONDAM).

Specialised Commissioning Oversight Group (SCOG)

The SCOG is a committee that consider CPAG recommendations and decide upon which new treatments to recommend for funding. The SCOG then submits its recommendations to the Specialised Services Commissioning Committee (SSCC) who make the final decision.


A sponsor is a pharmaceutical company who may not manufacture the technology being appraised but holds the marketing authorisation.


Specialised Service Commissioning Innovation Fund

Statutory Health Insurance Funds (SHIs)

These cover healthcare bills for the insured population. Being insured is compulsory in Germany and 92% of the population are covered by the SHIs.

Statutory Scheme

In 2008 the UK Government consulted on regulations to set up the statutory scheme, the purpose of which was to safeguard the financial position of the NHS by ensuring that there would be similar limits to the Pharmaceutical Price Regulation Scheme (PPRS) on the cost of branded health service medicines supplied by companies that decided not to join, or withdraw from, the PPRS. The statutory scheme’s policies may be changed at any time, subject to approval by Parliament. The statutory scheme was revised in 2018 and came into effect at the beginning of 2019.

Summary of Product Characteristics (SPC)

The SPC provides information for healthcare professionals on how to use medicines safely and effectively. The SPC does not give general advice on the treatment of particular medical conditions.

Surgically Invasive

An invasive device which penetrates inside the body, other than through an established body orifice, with the aid or in the context of a surgical operation.

Systematic Literature Review (SLR)

See ‘Systematic Review‘.

Systematic Review

Research that summarises the evidence on a clearly formulated question according to a predefined protocol. Systematic and explicit methods to identify, select and appraise relevant studies, and to extract, collate and report their findings are used. Statistical meta-analysis may or may not be used.

Technology Appraisal (Single: STA; Multiple: MTA)

The process of developing recommendations on the use of new and existing health technologies within the NHS in England. A multiple technology appraisal will normally cover more than 1 technology, or 1 technology for more than 1 indication. A single technology appraisal covers a single technology for a single indication.

Technology Assessment (TA)

The process of evaluating the clinical, economic and other evidence relating to the use of a technology and to formulate guidance on its use. See ‘HTA‘.

Technology Transfer Office (TTO)

Technology transfer, also called transfer of technology (TOT), is the process of transferring skills, knowledge, technologies, methods of manufacturing, samples of manufacturing and facilities among governments or universities and other institutions to ensure that scientific and technological developments are accessible to a wider range of users who can then further develop and exploit the technology into new products, processes, applications, materials or services.

Temporary Authorisations for Use (ATU)

The ATU process is an exceptional procedure making available medicinal products that have not yet been granted a marketing authorisation or that are not yet commercialised in France. The aim of ATUs is to provide early access to new promising treatments where a genuine public health need exists.

There are two types of ATU:

  • Named patient ATU: issued for a single named patient, at the request of and under the responsibility of the prescribing physician. This type of ATU concerns medicinal products presumed to be effective, and to have an acceptable drug safety profile in the light of the data available.
  • Cohort ATU: concerns a group or sub-group of patients, treated and monitored according to criteria fully defined in a protocol for therapeutic use. It is issued at the request of the holder of the licensing rights, which must commit to submit a marketing authorisation application within a determined period. This type of ATU concerns medicinal products strongly presumed to be effective and to have an acceptable safety profile, having reached an advanced stage of development, for example with a marketing authorisation dossier currently being compiled or registered.

Temporary Recommendation for Use (RTU)

RTUs are issued for medicines that already have a marketing authorisation in a different indication and are commercialised in France, whereas ATUs are for products without marketing authorisation at all. RTUs apply to all medicines, whether available in retail pharmacies or in hospitals, and stipulate that pharmaceutical companies are required to monitor patients taking their medicine.

Terminated Appraisal

The single technology appraisal process relies on manufacturers or sponsors submitting evidence, in line with NICE’s specification. Occasionally, they do not make a submission or the submission does not meet the specification. The appraisal is therefore terminated and NICE asks NHS organisations to take into account the reasons why the manufacturer or sponsor did not make an evidence submission when making local decisions on whether to offer the treatment.

The Department of Health (DoH), Ireland

The Department of Health supports the Minister for Health and the Government by advising on the strategic development of the health system including policy and legislation and evaluating the performance of the health and social services.

Transparency Committee (CT)

Part of the HAS in France, the CT provide independent scientific advice concerning the usefulness, interest and good use of drugs when there is a demand by the pharmaceutical company to have the medicine enlisted on a positive list to be reimbursed.

U.S. Food & Drug Administration (FDA)

The FDA is responsible for ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices in the USA; as well as ensuring the safety of food products, cosmetics, and products that emit radiation.

UK Medicines Information (UKMi)

The UKMi is an NHS pharmacy based service aimed to support the safe, effective and efficient use of medicines by the provision of evidence-based information and advice on their therapeutic use.

The service has two broad functions:

  • to support medicines management within NHS organisations
  • to support healthcare professionals optimise use of medicines for individual patients

UK Trade & Investment (UKTI)

See ‘DIT‘.


The term given to drugs that are used to treat extremely rare diseases that are chronically debilitating or life-threatening, with a prevalence of less than 1 in 50,000.

Voluntary Scheme

The 2019 Voluntary Scheme for Branded Medicines Pricing and Access (Voluntary Scheme) replaced the 2014 Pharmaceutical Pricing Regulation Scheme (PPRS). This scheme is negotiated by the Department for Health and Social Care (DHSC) and the Association of the British Pharmaceutical Industry (ABPI). The purpose of the scheme is to simplify, streamline and improve access, pricing and uptake arrangements for cost effective medicines.


Voluntary Scheme for Branded Medicines Pricing and Access – see Voluntary Scheme.

Welsh Health Specialised Services Committee (WHSSC)

The Welsh Health Specialised Services Committee (WHSSC) is responsible for the joint planning of Specialised and Tertiary Services on behalf of Local Health Boards (LHBs) in Wales. Every year, WHSSC receives money from the LHBs to pay for specialised healthcare for everyone who lives in Wales and is entitled to NHS care.

The WHSSC was established to ensure that the population of Wales has fair and equitable access to the full range of specialised services. In establishing WHSSC to work on their behalf, the seven LHBs recognised that the most efficient and effective way of planning these services was to work together to reduce duplication and ensure consistency.

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