The European Commission’s proposals for greater cooperation on health technology assessments across the EU that would impose mandatory joint clinical assessments for some products are in breach of the EU’s subsidiarity and proportionality principles, say Germany, France, the Czech Republic and Poland.
Germany and France Round On European Commission HTA Cooperation Proposals
Plans from the European Commission that would oblige all EU member states to consider joint clinical assessments have come under fire from Germany, France, Poland and the Czech Republic.
More from Europe
• By
Proposals to reform Spain’s reference pricing system are out of whack with the national pharmaceutical strategy published in December, six industry associations have warned.
• By
Faced with Trump’s hostile tariff moves, the UK aims to speed up clinical trial start times to support its pharma sector and invest £600m in a new health data research service.
• By
The chair of a European Medicines Agency working group on reducing animal testing said that companies can provide “thoughts and suggestions” in relation to a review of its scientific guidelines on regulatory testing requirements and new approach methodologies.
• By
The European Medicines Agency’s latest move towards a more streamlined process for biosimilar registration in Europe was the hottest topic at last week’s annual biosimilars conference held by Medicines for Europe in Amsterdam.
More from Geography
• By
Israel has introduced a new framework to expedite the marketing approval of medicines, make the country a more attractive destination for drug registration and help reduce drug prices through market competition.
• By
Stay up to date on regulatory guidelines from around the world with the Pink Sheet’s Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.
• By
US-based Colossal Labs has claimed to bring back the dire wolf from extinction. While the science is not as dramatic in India yet, cell and gene therapies are making progress as treatments for cancer and other diseases. Pink Sheet takes a look at what is driving CGT success and growth