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Consultations

Please note that this table shows consultations from 1st January 2018. Please refer to our consultations archive for consultations before this date.

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Consultation titleDateClosing dateOpen?CountryOrganisationPriorityKey commentsLinks
PMPRB Draft Guidelines Consultation2019-11-292020-01-20YCanadaPMPRB

G

Canada’s Patented Medicine Prices Review Board (PMPRB) has launched a consultation on its new Guidelines including changes for both grandfathered and non-grandfathered medicines.

The consultation follows the announcement of new Patented Medicines Regulations, coming into effect from 1st July 2020, which, as MAP reported in August, will alter conditions such as which countries Canada may use for international reference pricing (IRP).
Consultation
NHS England Commercial Framework draft2019-11-012020-01-10YUK - EnglandNHS England

G

NHS England are consulting on its draft Commercial Framework which sets out additional commercial flexibilities availableConsultation
Community pharmacy drug reimbursement2019-10-212019-12-13YUK - WalesWelsh Government

Y

The Welsh Government is holding a consultation on proposed changes to reimbursing community pharmacy contractors for drugs they dispense against NHS prescriptions.Consultation
National conversation on rare diseases2019-10-112019-11-29NUKDHSC

G

The Department of Health and Social Care has begun its ‘national conversation’ on rare diseases by developing surveys to understand the main barriers facing the community.

In July 2019 Baroness Blackwood, Parliamentary Under Secretary of State, announced the project aiming to find common themes to feed into an overarching framework.
Survey
NHS (Pharmaceutical Services) (Wales) Regulations 20202019-09-302019-11-25NUK - WalesWelsh Government

O

The Welsh Government is consulting upon the details of the draft NHS (Pharmaceutical Services) (Wales) Regulations 2020, which will revoke and replace the 2013 iteration. The 2020 Regulations will build upon the changes introduced in 2017, which aimed to transform the Community Pharmacy Contractual Framework to deliver more clinical services through community pharmacies.Consultation
Supply and Demand of Medicines in Scotland2019-09-272019-11-22NUK - ScotlandNHS Scotland

O

The Committee is seeking views on the management of the medicines budget, including the clinical and cost effectiveness of prescribing. We want to hear about purchasing, prescribing, dispensing and consumption of medicines.Consultation
EUnetHTA consultation on "Practical considerations when critically assessing economic evaluations"2019-08-192019-10-11NEUEuropean Network for Health Technology Assessment (EUnetHTA)

G

EUnetHTA has opened a public consultation on "Practical considerations when critically assessing economic evaluations", aimed at HTA assessors.Consultation
MHRA Consultation on engaging patients and the public2019-07-152019-10-07NUK - EnglandMHRA

O

The MHRA has launched a consultation into the best ways to engage and involve patients in the MHRA’s work, in order to develop a more systematic approach to engagement strategies.Consultation
HTAI Consultation on 2020-25 Strategic Plan2019-08-142019-09-29NUK - EnglandHealth Technology Assessment International

G

HTAI has launched a consultation regarding its short-term strategic goals, which will feed into its finalised plan due for publication in January 2020.Consultation
Community pharmacy drug reimbursement reform2019-07-232019-09-17NUK - EnglandDepartment of Health and Social Care (DHSC)

Y

The Department of Health and Social Care (DHSC) has launched a consultation regarding the ways that community pharmacy contractors are paid for drugs dispensed through NHS prescriptions.Consultation
EUnetHTA Consultation on Process of Information Retrieval2019-08-072019-09-13NEUEUnetHTA

G

Consultation on the methodological guideline “Process of information retrieval for systematic reviews and health technology assessments on clinical effectiveness”Consultation
NICE Consultation on how it uses real world data statement of intent2019-06-132019-09-13NUK - England NICE

G

NICE has announced that it will explore how it uses real world data in forming its guidance.

As part of this, it has put out a statement of intent for consultation.

NICE (National Institute of Health and Care Excellence) is now proposing to extend its use of real world data to include sources such as:

  • hospital records of operations

  • registries which collect data on how particular treatments are used

  • surveys of people using services

  • data collected on national trends, such as how many people have a condition


The statement of intent, published by NICE, describes what kind of evidence NICE currently uses to develop guidance, what broader types of data are available, when and why broader types of data should be considered, and also practical considerations associated with data analytics.

Consultation
Consultation on proposed methods adaptations for assessments of potential cures and other transformative therapies2019-08-082019-09-06NUSAICER

G

The Institute for Clinical and Economic Review (ICER) is consulting on a draft set of proposed adaptations to its value framework to be applied in the assessment of potential cures and other treatments that qualify as “single or short-term transformative therapies,” or SSTs. Consultation
NHS consultation on Transparency and openness in health and social care research2019-06-172019-09-06NUK - EnglandNHS Health Research Authority

O

The HRA is creating an overall vision, series of commitments and strategy to make health and social care research more transparent. To incorporate feedback from the public and research professionals into the final strategy, about how some of those commitments will work in practice and the measures that will be taken, the HRA is running an online survey and holding a series of open workshops across the UK, as well as contacting patient groups and Research Ethics Committees and the approvals staff who support them.Consultation
Health and Social Care Committee inquiry into NHS investment and the NHS Long Term Plan2010-07-092019-08-22NUK - EnglandHouse of Commons Health and Social Care Committee

Y

The Committee is to investigate how investment capital expenses, training, social care and public health (to be outlined in upcoming funding settlements) could best support NHS effectiveness, and the implementation of the objectives outlined in the Long Term Plan.Consultation
Public consultation by HAS on the assessment of efficiency2019-07-012019-08-09NFranceHAS

G

On 2011, HAS published a first version of the methodological guide, which explained the principles the HAS relies on to conduct or evaluate efficiency assessments, whether in the context of public health assessments carried out by HAS or, since 2013, as part of the efficiency evaluations issued by the CEESP – Commission Évaluation Économique et de Santé Publique (Economic and Public Health Evaluation Committee).

On the 11th of June 2019, the CEESP validated a second provisional version, updating the methodological guide.

The purpose of the consultation is to open space for scientific exchanges on the methodological principles HAS uses to evaluate efficiency of a technology or a health program.
Consultation
EMA consultation: key principles for the electronic product information of EU medicines2019-01-312019-07-31NEUEMA

Y

The European Medicines Agency (EMA) has worked with the Heads of Medicines Agencies (HMA) and the European Commission (EC) to prepare a proposal for digitising product information for medicines marketed in the EU. The information consists of the package leaflet and Summary of Product Characteristics (SmPC), and converting them to an electronic format will enable the latest versions to be shared immediately across Europe. The EMA point to other limitations that the new format should also solve.Consultation
EMA Consultation on draft guideline2019-01-142019-07-31NEUEMA

O

Antimicrobial resistance is a global public health problem. Regulators in the European Union, the United States and Japan have had extensive discussions over the last few years to explore and agree how to align as much as possible their respective data requirements so that medicine developers can design clinical trials that meet the evidence needs of multiple regulatory agencies. The revised guidance reflects the outcome of these discussions.

In addition, it offers clarification on the clinical development of antibacterial agents that are expected to address an unmet medical need, in accordance with experience gained from previous regulatory decisions.

Specific advice has also been added with regards to the EU regulatory requirements to develop medicines for the treatment of uncomplicated urinary tract infections and gonorrhoea.
Consultation
NICE indicator process guide2019-04-162019-07-15NUK - EnglandNICE

G

The NICE indicator process guide describes the process NICE uses to develop indicators from NICE quality standards, NICE guidance and NICE accredited sources. NICE indicators are used in a range of national measurement frameworks including the CCG Outcomes Indicator Set (CCG OIS) the CCG Improvement and Assessment Framework (CCG IAF), NHS England’s General Practice Indicators (GPI) and the Quality and Outcomes Framework (QOF).Consultation
HAS consultation on vaccine use2019-06-122019-07-10NFranceHAS

Y

The purpose of the drafted recommendation is to define actions that need to be taken in the absence of documentation or incomplete information on vaccination status. The recommendation was drafted with the support of a multidisciplinary group following a systematic review of the literature.
Consultation
AHSN and NHSX Consultation on data-driven health technologies2019-05-092019-07-03NUKAcademic Health Science Networks and NHSX

Y

AHSN and NHSX have opened a consultation upon data-driven technologies in healthcare. This aims to progress the digital transformation envisioned in the NHS Long Term and entrusted to the NHSX.Survey
Regulatory Science to 20252018-12-192019-06-30NEUEMA

Y

EMA has published its draft ‘Regulatory Science to 2025’ strategy for a six-month public consultation. This is a proposed plan for advancing the Agency’s engagement with regulatory science over the next five to ten years, covering both human and veterinary medicines.

Stakeholders are invited to send their comments via an online questionnaire by 30 June 2019.
Consultation
EUnetHTA public consultation on REQueST® tool and its Vision paper2019-05-062019-06-28NEUEUnetHTA

Y

REQueST® (Registry Evaluation and Quality Standards Tool) is built upon the results of the PARENT joint actions with a view to help HTA organisations in guiding and evaluating registries for effective usage in HTA.
The Vision paper summarises key learnings from the Joint Action 3 and provides recommendations for long-term delivery, use and sustainability of REQueST. The document also provides recommendations for a permanent HTA cooperation on post-launch evidence generation.
Consultation
OHE Consultation on Indication-Based Pricing (IBP)2019-05-102019-06-24NUKOffice of Health Economics

Y

The OHE has opened a consultation on indication-based pricing, as it attempts to innovate drug reimbursement to bring practices into line with industry developments.Consultation
Feedback on blended payment model2019-04-262019-05-31NUK - EnglandNHS Improvement

O

NHS Improvement is gathering feedback on the operation of its new blended payment model for emergency and mental health careConsultation
Nominations for High Cost Drugs list2019-04-232019-05-31NUK - EnglandNHS England

G

Nominations for drugs (and devices) to be added to (or removed from) the High Cost Drugs and Devices Lists in the next iteration (2020/21) of the National TariffConsultation
Preventing abuse of the R&D tax relief for SMEs2019-03-282019-05-24NUKHMRC

Y

This consultation is upon proposals to cap the R&D tax relief scheme at three times the relevant company’s total PAYE and NICs liability for that year, which will be implemented from April 2020. Consultation
NICE Consultation on proposed changes and additions to existing NICE menu indicators used in the QOF and new NICE indicators2019-04-172019-05-16NUK - England NICE

Y

This consultation presents amended and new indicators with a focus on personalised care, addressing over- and under-treatment, and ensuring the best outcomes for patients. New NICE indicators included are: proposed changes and additions to existing NICE menu QOF indicators in the QOF, new indicators for general practice and new indicators - local authority.Consultation
UPDATED DEFINITION OF HTA2019-03-202019-04-30NInternationalHTAi

Y

The joint task group is now issuing this call for input from the HTA community to build broad consensus on the updated definition of HTA. Please view the document here: Open Consultation on a Proposed Updated Definition of Health Technology Assessment.Consultation
Your views on access to rare disease medicines2019-04-032019-04-19NUKGenetic Alliance UK

G

Genetic Alliance UK are working on a policy project to improve access to medicines for rare diseases. This project is called Resetting the Model. To inform this project, we are launching a survey to find out the views of patients, carers, patient organisations and industry members on access to medicines for rare diseases.Survey
Role of big data for evaluation and supervision of medicines in the EU2019-02-152019-04-15NEuropeEMA / HMA

Y

Stakeholder and public consultation on the conclusions of the Februrary 2019 summary report on the HMA-EMA Joint Big Data Taskforce.Consultation
OLS Survey on EAMS2019-02-182019-03-08NUKOffice for Life Sciences

G

The Early Access to Medicines Scheme (EAMS) gives patients with life threatening or seriously debilitating conditions early access to new medicines that do not yet have a marketing authorisation, when there is a clear unmet medical need. Since the scheme launched in 2014, over 1,500 patients have benefited from EAMS, with 69 Promising Innovative Medicine (PIM) designations and 22 Scientific Opinions (SOs) being issued.

The Office for Life Sciences (as part of the Department for Health and Social Care) is seeking to collect views from industry to assess i) overall awareness of the scheme, ii) how widely it is being used, iii) how it is perceived and iv) the priority potential areas for change. OLS have asked the ABPI, BIA and EMIG to circulate this survey to their members to obtain a wide-range of views.
Survey
Peer Approved Clinical System (PACS) Tier Two – 6-month review2019-02-192019-02-28NUK - ScotlandScottish Government

Y

Early reservations were raised by NHS Boards ahead of the launch of PACS Tier Two.

The former Cabinet Secretary for Health and Sport was aware of these concerns held by the NHS in Scotland and noted that there would be reviews of the policy after 6 and 12 months.
MAP story
NHS England: Items which should not routinely be prescribed in primary care2018-11-282019-02-28NUK - EnglandNHS England

Y

Set out in the consultation document are proposals for an review and update of Items which should not routinely be prescribed in primary care: Guidance for CCGs, published in Nov 2017. The commissioning guidance, upon which we are consulting, will be addressed to CCGs to support them to fulfil their duties around appropriate use of prescribing resources. This will need to be taken into account by CCGs in adopting or amending their own local guidance to their clinicians in primary care. The aim of this consultation is to provide you with information about the proposed national guidance and to seek your views about the proposals.Consultation
2019/20 National Tariff
Payment System - Statutory Consultation
2019-01-232019-02-21NUK - EnglandNHS Improvement

G

NHS Improvement has opened the statutory consultation on proposals for changes to the National Tariff; this follows an informal consultation in the autumnConsultation
Public Health Outcomes Framework2019-01-212019-02-17NUK - EnglandPHE

O

The Public Health Outcomes Framework (PHOF) was established in 2012 and its indicators are reviewed every 3 years. Public Health England (PHE) is planning to update the PHOF in the summer 2019, to ensure that it continues to be relevant and meets the needs of users.Consultation
EMA epilepsy consultation2018-09-172019-02-17NEuropeEMA

Y

The present document is a third revision of the existing guideline. It should be considered as general guidance on the development of medicinal products for the treatment of epileptic disorders and should be read in conjunction with other EMA and ICH guidelines, which may apply to these conditions and patient populations.Consultation
ICER consultation on drug pricing in USA2019-01-172019-02-13NUSAICER

G

With guidance from a multi-stakeholder advisory group — comprising representatives from patient advocacy groups, pharmaceutical companies, and payers representing both Medicaid and the private market — ICER has developed a draft protocol for how it will conduct its UPI assessments. ICER proposes that its 2019 report will focus on up to 13 prescription drugs that experienced the most significant US price increases over the past 24 months, based primarily on which net price increases resulted in the largest overall budget impact for the US health system. ICER will review changes in the evidence base for each of these drugs and assess whether or not new clinical data exists that could suggest that the drugs could be significantly more beneficial for patients than what was previously understood.

A public comment period is now open for the draft protocol, and ICER will consider all feedback when finalizing its methodology for this initiative.
Consultation
Consultation on transparency in engagement between the EMA and medicines producers prior to application for market authorisation2018-10-072019-01-31NEUEuropean Ombudsman

Y

European Ombudsman inquiry into EMA processes for pre-submission engagement with companies. The Ombudsman is looking at the role of these in facilitating the development and availability of innovative medicines, and the risks to the objectivity around the authorisation process.Consultation
Evidence standards framework for digital health technologies2018-12-102019-01-07NUK - EnglandNICE

Y

This consultation is being conducted by NICE regarding their recently published evidence standards framework for digital health technologies. These standards aim to make it easier for innovators and commissioners to understand what good levels of evidence for digital healthcare technologies look like, while meeting the needs of the health and care system, patients, and users.Consultation
Public consultation on legislation on medicines for children and rare diseases launched2018-10-122019-01-04NEUEuropean Commission

Y

An evaluation is currently taking place of the legislation for medicines for special populations, including both children and rare diseases. This evaluation will assess the efficiency and effectiveness of the current European Union (EU) legislation following recent pharmaceutical developments, particularly recent incentives for research, development and marketing of children’s and rare disease medicines. The outcomes of the evaluation will help to shape the EU policy on medicines for these special populations.Consultation
Consultation on proposed IPI international reference pricing model for the US 2018-10-252018-12-31NUSA, but impact will be globalUS Dept. of Health and Human Services (HHS) / Centers for Medicare & Medicaid Services (CMS)

G

This is the US Government's consultation on Administration proposals to benchmark US drug prices to other developed countries, particularly Europe.Consultation
EMA neonatal consultation2018-09-172018-12-16NEuropeEMA

Y

The Guideline on the investigation of medicinal products in the term and preterm neonates was prepared during the period from 2007 to 2009 and came into effect in 2010 (EMEA/536810/2008). Considerable experience of assessing PIP applications covering neonatal age subset has been gained since then and it has become apparent that some essential questions arise repeatedly during the assessment of Paediatric Investigation Plans (PIP) applications for products intended to be investigated and used in neonates. Consultation
Draft Specification for Sarcoma services2018-10-122018-12-11NUKNHS England

O

NHS England has launched a consultation to seek views on proposed changes to Sarcoma Cancer Services.Consultation
Evaluation of the EU Orphan Regulation for the European Commission (DG SANTE)2018-09-202018-11-14NEUTechnopolis

G

Study was commissioned with the view to measure the efficiency, effectiveness, relevance, and EU added value of the EU Orphan Regulation as well as its coherence with other regulations. Expected by mid-2019, the study is meant to provide further information – in addition to the study reports of Copenhagen Economics on pharmaceutical incentives in Europe, and the 10-Year Report of the Paediatric Regulation – for the EU Commission to evaluate the existing regulatory framework and explore possible legislative changes.
The present survey is intended for companies involved in the development and/or marketing of medicines, which have, or may be eligible for, EU orphan designation and their representative trade associations
Survey
MHRA No Deal Brexit consultation2018-10-042018-11-01NUKMHRA

G

The MHRA is conducting a consultation on how legislation and regulatory processes would have to be modified in the event of a no deal Brexit. The overall approach, as detailed in the Government’s notice to stakeholders on 23rd August, is that new marketing authorisations would be submitted separately to both the MHRA for UK markets and the EMA for European markets. Existing EU marketing authorisations will be automatically converted into UK ones. The MHRA would be a stand-alone medicines and medical devices regulator, taking any decisions and carrying out any functions which are currently taken or carried out at EU-level.

The consultation includes optional sections on Medicines, Clinical Trials, Medical Devices, Fees and the National Institute for Biological Standards and Control. Each section details the proposed changes, and allows respondents to indicate whether they support the proposals and provide comments.

The ABPI and BIA have submitted a joint response to this consultation, which can be found here.
Consultation
Consultation on ATMPs Good Clinical Practice2018-08-092018-10-31NEuropeEuropean Commission

G

Taking account the advances and experience in the field the Commission services have developed a new draft Guidelines on Good Clinical Practice specific to Advanced Therapy Medicinal Products with the European Medicines Agency and the expert group of the competent authorities of the Member States. The Guidelines will adapt good clinical practice requirements (“GCPs”) to ATMPs. It will be a document that focuses on ATMP specificities only and which applies in addition to the GCP Guidelines of The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). The Directorate General for Health and Food Safety wants to give an opportunity for concerned stakeholders to express their views on the GCP requirements that should apply to ATMPs.Consultation
Engagement on proposed 2019/20 National Tariff2018-10-092018-10-29NUK - EnglandNHSI / NHSE

G

Stakeholder engagement exercise consulting on published proposals for the 2019/20 National Tariff.Consultation
NICE: Drug allergy diagnosis and management consultation2018-10-032018-10-16NUK - EnglandNICE

O

NICE has announced a consultation to update the clinical guidelines on drug allergy diagnosis and management (CG183). The consultation runs from Wednesday 3 October to 5pm on Tuesday 16 October 2018.

NICE clinical guidelines are recommendations, based on the available evidence, for the treatment of patients by healthcare and other professionals.
Consultation
Health and Social Care Select Committee inquiry into the impact of a no-deal Brexit on health and social care2018-09-182018-10-15NUKHealth and Social Care Select Committee

G

Health and Social Care Committee to consider impact of a "no deal Brexit" on health and social care system.

The Health and Social Care Committee will be holding an evidence session in October on the impact of a no-deal Brexit on health and social care.

The session will be an opportunity for the Committee to follow up its earlier reports, Brexit and health and social care: people and process and Brexit: medicines, medical devices and substances of human origin.
Enquiry
Consultation on ABPI Code of Practice2018-08-292018-10-10NUKPMCPA (ABPI)

G

Consultation on changes to the ABPI Code of Practice Consultation
NHSE Consultation on long-term plans for the NHS in England2018-08-242018-09-30NUK - EnglandNHS England

G

Consultation on priorities for design and improvement of NHS services in England in order to guide the development of a strategic plan for the next ten years. Input is sought from both staff and any stakeholders who work with NHS services.Consultation
ANSM Consultation on paracetamol safety2018-08-202018-09-30NFranceANSM

O

Paracetamol is a safe and effective medicine under normal conditions of use.

But in case of misuse, especially overdose by combining several products containing paracetamol and / or by non-compliance with their dosage, paracetamol can cause serious damage to the liver in some irreversible cases. The misuse of paracetamol is the leading cause of liver transplantation of drug origin in France.

The ANSM invites anyone who wishes to participate, until 30 September 2018 , in the public consultation "Hepatic risk linked to paracetamol overdose: setting up a warning message on the boxes (packaging)".
Consultation
NHS England Consultation on evidence based interventions2018-07-042018-09-28NUK - EnglandNHS England

G

Public consultation on the design principles of the evidence based intervention programmeConsultation
Statutory scheme to control costs of branded health service medicines2018-08-072018-09-18NUKDepartment of Health and Social Care

G

Consultation on reforms to the statutory regulations scheme for pharmaceutical price setting and rebate.

The proposals cover three areas: Changing the payment percentage; Including all biological medicinal products (including biosimilars) within the scope of health service medicines captured by the payment mechanism, price controls and information requirements; and
Changing the application of the payment system for sales of medicines supplied under a contract with a contracting authority based on a framework agreement or under a public contract.
Consultation
NICE charging for Technology Appraisal (inc. HST) plus amendments to Appeal Panels 2018-08-092018-09-14NUK - EnglandNICE / DHSC

G

DHSE seeks comments on proposals to charges for NICE technology appraisals including HST from April 2019. It would also allow NICE Appeals Panels to recruit members from healthcare bodies across the UK, rather than just England.Consultation
NHS England Consultation on GP contract reform2018-07-042018-08-31NUK - EnglandNHS England

G

Proposed contract changes around payments for regional variations and digital implementations.Consultation
HIQA Consultation on ePrescriptions2016-07-182018-08-31NRepublic of IrelandHIQA

O

The consultation process will take place over a six-week period. In this way, the public, service users and service providers will have the opportunity to provide feedback and become involved in the future of ePrescribing in IrelandConsultation
Draft qualification opinion on Cellular therapy module of the European Society for Blood & Marrow Transplantation (EBMT) Registry2018-06-292018-08-21NEuropeEMA

Y

EBMT requested qualification of the cellular therapy module of the EBMT Registry as suitable for performing pharmacoepidemiological studies for regulatory purposes, concerning CAR-T cell therapy for haematological malignancies.Consultation
Study supporting the Evaluation of the European Medicines Agency Fee System2018-05-022018-08-03NEuropeEuropean Commission

G

The consultation aims to elicit information, views and concerns of all groups having an interest in the EMA fee system and its implementation.Consultation
Cost-Effectiveness Methodology for Vaccination Programmes and Procurement (CEMIPP) Report2018-02-262018-07-02NUK - EnglandDepartment of Health

G

The consultation includes a recommendation that the cost-effectiveness threshold for immunisation programmes should be lowered to £15,000 per QALY to bring it into line with evidence estimating healthcare opportunity costs and the DHSC’s methodology for impact assessments and there is an attempt to make a connection with evaluation of medicines.Consultation
Developing NICE guidelines: the manual2018-04-032018-06-25NUKNICE

G

NICE guidelines make evidence‑based recommendations on a wide range of topics, from preventing and managing specific conditions, improving health, and managing medicines in different settings, to providing social care and support to adults and children.Consultation
Personal health budgets and integrated personal budgets: extending legal rights2018-04-062018-06-08NUK - England Department of Health and Social Care

G

The Department of Health and Social Care has opened a consultation seeking views on giving more people the right to have personal health budgets and integrated personal budgets Consultation
Update of The Licensing (Procedure) (Scotland) Regulations 20072018-03-142018-06-06NUK - ScotlandScottish Government

Y

The Procedure Regulations came into force on 1st February 2008 and have not been updated since issue. They provide for various procedural matters under the Licensing (Scotland) Act 2005. This consultation is seeking views, in particular, regarding the sections of these Regulations which relate to the public notification process. The consultation includes 4 open questions relating to the procedure regulations.Consultation
Public consultation on the review of the SME definition2018-02-062018-05-06NEuropeEuropean Commission

Y

The SME definition as provided in Recommendation 2003/361/EC is the structural tool to identify enterprises that are confronted with market failures and particular challenges due to their size, and therefore are allowed to receive preferential treatment in public support.

It is a widely used tool in EU policies such as competition (state aid), structural funds, research and innovation (Horizon 2020). Moreover, the SME definition is relevant for some European administrative exemptions and reduced fees, such as for Regulation on registration, evaluation, authorisation and restriction of chemicals (REACH).

The Commission is currently preparing for an evaluation and possible revision of some aspects of the SME definition. This public consultation is part of this process and will allow any interested actor to provide feedback on the evaluation and impact assessment of the SME definition.
Consultation
ACO contracts2018-01-252018-04-19NUK - EnglandNHS England

G

The consultation will set out how the ACI contract fits within the NHS as a whole, address how the existing statutory duties of NHS commissioners and providers would be performed under it, and will set out how public accountability and patient choice would be preservedConsultation
Sharing data for the "NICE Technology Appraisals in the NHS in England"2018-02-05 2018-04-04NUK - EnglandNICE

G

This consultation seeks views from companies who produce medical technologies, and diagnostic products, about sharing their data with NHS Digital so that it can be published on the "NICE Technology Appraisals in the NHS in England" (Innovation Scorecard) publication.

The Scorecard is a quarterly publication that provides information on the uptake of NICE approved innovative medicines and medical technologies in the NHS in England. It is commissioned by the Department of Health and published by NHS Digital.

Making information available (via the Scorecard) about the availability of innovative products will help raise awareness of these products across NHS organisations, helping improve their access for patients.
Consultation
GOC launches Education Strategic Review concepts and principles consultation2017-12-122018-03-16NUKGeneral Optical Council (GOC)

O

The General Optical Council has opened a consultation on the concepts and principles that could underpin optical education and training in the future, as part of its Education Strategic ReviewConsultation
Conditions for which over the counter (OTC) items should not routinely be prescribed in primary care: A consultation on guidance for CCGs2017-12-202018-03-14NUK - EnglandNHS England

Y

NHS England is launching a public consultation on reducing prescribing of over-the-counter medicines for 33 minor, short-term health concerns.

The changes look to free-up up to £136 million to expand other treatments for major conditions.
Consultation
Consultation on proposed changes to the technology appraisals programme - phase 22018-01-192018-03-01NUK - EnglandNICE

G

In October 2017 we consulted on amendments to our technology appraisal process. The aim of the proposals was to enable more topics to be processed through the current four appraisal committees.

We have now updated our guide to the processes of technology appraisals in line with these amendments. The draft guide is now open for consultation.
Consultation
Sustainability and Transformation in the NHS inquiry2018-02-232018-02-27NUKPublic Accounts Committee

Y

The Committee will ask representative from the Department of Health and Social Care, NHS England and NHS Improvement about how they will ensure to put the NHS on a sustainable financial footing in the future, whilst managing increasing demandConsultation
Public release of clinical information2017-12-092018-02-22NCanadaHealth Canada

Y

Health Canada invites stakeholder's comments on how it carries out this proposal, including the:
  • regulatory approach
  • scope of clinical information that would be publicly available following a final regulatory decision
  • clinical information that has ongoing commercial value and could be withheld from public release
Consultation
PMPRB Guidelines Scoping Paper – High Level Overview of Potential New Framework2017-12-022018-02-15NCanadaPMPRB

G

While the details of the framework remain to be worked out through consultation, its basic structure can be described as a risk-based approach to pricing review that is broken down into five main partsConsultation
Naming of Biologic Drugs2018-01-182018-02-09NCanadaHealth Canada

Y

Health Canada and the Institute for Safe Medication Practices Canada (ISMP Canada) are seeking input from healthcare providers, consumers, and other interested and affected stakeholders on different approaches to the naming of biologic drugs, including biosimilars, in Canada.

The objective of the consultation will be to gain insight into stakeholder views on the practical impacts of different approaches to the naming of biologic drugs and biosimilars throughout the medication-use process, including prescribing, dispensing, and adverse drug reaction reporting.
Consultation
Consultation to simplify and strengthen arrangements for research in the NHS2017-12-012018-02-01NUK - EnglandNHS England

Y

A consultation has been launched to simplify and standardise the process for getting research projects up and running in the NHS.

Cuts to bureaucracy and faster access to new and innovative treatments, are at the heart of 12 actions also agreed by the NHS England Board to support research and its application in the NHS.
Consultation
Review of Brain/CNS Cancer Quality Performance Indicators Consultation2017-12-182018-01-26NUK - ScotlandScottish Government

Y

The Scottish Government has opened a consultation on why clinical and public engagement is crucial to ensure wide inclusiveness of clinical colleagues across NHS Scotland and Revised Brain and Central Nervous System Cancer QPIsConsultation
Modernising radiotherapy services in England - Consultation on proposed service
specification
2017-10-182018-01-24NUK - EnglandNHS England

O

The development of the proposed service specification sits alongside NHS England’s £130 million investment in radiotherapy equipment, which was announced last year and is aimed at delivering the vision for radiotherapy services. The proposed specification sets out how modernised services should be organised across England so that patients can access sustainable, high-quality and safe treatment. It also describes the benefits of doing things differently, and why the changes are neededConsultation
AWMSG Five Year Strategy 2018-20232017-12-152018-01-19NUK - WalesAWMSG

G

AWMSG is committed to ensuring that patients in Wales have access to clinically effective and cost-effective medicines that will improve their health outcomes. Over the next five years AWMSG will aim to ensure that prescribing in Wales is consistent with the optimal prescribing practices in the rest of the UK. The strategy for the next five years (1 April 2018–31 March 2023) builds on the success of the previous strategy (2013– 2018).Consultation
Serious eye disorders2017-12-152018-01-18NUKNICE

G

The National Institute for Health and Care Excellence has opened a consultation on Serious eye disorders.Consultation
Regulatory fees for 2018/192017-10-262018-01-18NUK - EnglandCare Quality Commission

O

The Care Quality Commission has opened a consultation on calculating the fees that providers of health and adult social care must pay in order to be registeredConsultation
Asthma (update): Topic engagement2017-12-152018-01-15NUKNICE

Y

The National Institute for Health and Care Excellence has opened a consultation on asthma treatment
as well as changes in the areas for improvement for asthma
Consultation
Evaluation of the legislation on medicines for children and rare diseases2017-12-112018-01-08NEuropeEuropean Commission

Y

the EU Commission intends to conduct some activities by the end of their mandate, in order to complement the already-completed or ongoing studies on Supplementary Patent Certificates (SPCs). Stakeholders are given the possibility to submit feedback on the roadmap by 8 January 2018.Consultation
Supplementary protection certificates (SPCs) and patent research exemptions2017-10-122018-01-04NEuropeEuropean Commission

O

The Single Market Strategy, adopted in October 2015, announced that the Commission will ‘consult, consider and propose further measures, as appropriate, to improve the patent system in Europe, notably for pharmaceutical and other industries whose products are subject to regulated market authorisations’.Consultation

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