1. Pink Sheet
  2. >>Geography
  3. >>Europe

Slowly Does It: The EMA’s Approach To Expanding Multinational Drug Assessment Concept

 
• By Maureen Kenny

The European Medicines Agency’s multinational approach to drug assessment under which new marketing authorization applications are evaluated by teams formed according to expertise rather than by country has proved popular and is now being expanded to the “complex” post-authorization phase. The multinational assessment team (MNAT) concept will be broadened in phases, starting in April. Issues relating to sustainability, knowledge transfer and payment of fees to participating national authorities all have to be considered.

The European Medicines Agency is taking a step-by-step approach to expanding an initiative that for the past four years has enabled national authorities to participate in the initial assessment of new medicines through the involvement of single experts rather than via an entire team.

Until now, the initiative has applied only to procedures under the pre-authorization phase. Starting in April, the agency is expanding...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from Europe

EU-Level Efforts To Mitigate Drug Shortages Unsuccessful, Audit Reveals

 
• By Eliza Slawther

Actions taken by the European Commission and European Medicines Agency to tackle critical shortages of medicines have not succeeded in practice and further systemic improvements are required to address supply issues, a report from the European Court of Auditors has found.

Canada, Britain And Australia Push For Greater International Regulatory Alignment

 
• By Eliza Slawther

Canada’s drug regulator is using amended drug laws to increase the use of regulatory reliance pathways to improve efficiency and support international alignment, while the UK’s MHRA has held talks with Australia’s TGA on topics including the role of AI in regulatory frameworks.

Sanofi’s Rilzabrutinib & Belumosudil Among Seven Drugs Facing EMA Oral Explanations

 
• By Vibha Sharma

The sponsors of seven new medicines nearing the end of their EU regulatory review are due – or possibly due – to appear before the European Medicines Agency’s human medicines committee, the CHMP, to address remaining concerns about their marketing applications.

EU’s Draft GMP Guideline Signals Major Cultural Shift In Pharma Quality Compliance

 
• By Vibha Sharma

While the EU's draft good manufacturing practice guideline on pharmaceutical quality systems reflects modern quality management principles, it also presents significant operational and resource challenges for drug companies.

More from Geography

Canada, Britain And Australia Push For Greater International Regulatory Alignment

 
• By Eliza Slawther

Canada’s drug regulator is using amended drug laws to increase the use of regulatory reliance pathways to improve efficiency and support international alignment, while the UK’s MHRA has held talks with Australia’s TGA on topics including the role of AI in regulatory frameworks.

Publisher’s Spotlight: Shortlist Unveiled For Citeline Japan Awards

 
• By Ian Haydock

Shortlists of potential winners in all categories of the Citeline Japan Awards 2025 have now been released. Join us at the event in Tokyo on October 21, it’s not too late to book your table!

Ex-CDC Leaders Reveal New Details Of Kennedy’s Plans For ACIP, Vaccine Schedule

 
• By Sarah Karlin-Smith

The former CDC director and recently departed chief medical officer tell senators that Kennedy plans to target the childhood vaccine schedule despite a lack of scientific data to support his agenda.