Concerns about pharmaceutical products from India and China
There are escalating concerns regarding the quality and safety of medicinal products from India and China, as statistics indicate that … read more »
EMA and FDA publish report on supporting developers in early access
The EMA and US FDA have published a report following a joint workshop on supporting medicine developers in early access … read more »
Tumour-agnostic drug receives positive opinion for conditional approval in EU-first
The EU looks set to authorise its first tumour-agnostic new cancer drug, already approved in the USA, Canada and Brazil. … read more »
Draft amendments to key legislation finalised, in preparation for potential no-deal Brexit
As Brexit date approaches, the UK government has finalised draft amendments to key legislation which will ensure that the MHRA … read more »
EMA welcome European Ombudsman’s recommendations on pre-submission activities
The EMA has welcomed recommendations from the European Ombudsman, recognising the value of scientific advice but calling for additional transparency. … read more »
EU and US complete GMP harmonisation process
The FDA and EMA have completed implementation of their mutual recognition agreement for GMP inspection, with Slovakia being recognised by … read more »
Guidance released for reporting and communication of medicine shortages in the EU
The EMA and HMA have released a set of guidance for marketing authorisation holders and others to help them report … read more »
Committee for Medicinal Products for Human Use, June 2019 Meeting
The European Medicines Agency has published the meeting highlights of the June meeting of its Committee for Medicinal products for … read more »
EFPIA responds to EMA consultation on Regulatory Science Strategy
EFPIA has released its response to an EMA consultation, calling for support for innovation in clinical trials, improvement in regulatory … read more »
European bodies launch further push for publication of clinical trial results
The European Medicines Agency has called for improved publication rates for clinical trials, with 5,855 of a possible 18,432 as … read more »
