Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By


Adaptive licensing: Is the EMA's Rasi heading for a fight with the commission and others in EU?

This article was originally published in SRA

Executive Summary

The European Commission and German health technology assessors have poured cold water on aspirations by European Medicines Agency head Guido Rasi to introduce an adaptive licensing approach for evaluating and approving medicines.

You may also be interested in...

EMA Defends Adaptive Pathways Against Fresh Attack Following Pilot Report

The European Medicines Agency has dismissed a call to stop accepting applications for its adaptive pathways program until it has better evidence on how to use real-world data.

Adaptive Pathways: Companies Advised To Consider Hurdles As EMA Accepts More Applications

The European Medicines Agency has released its keenly awaited final report on it adaptive pathways pilot and says it will continue to accept applications for the new drug development concept. Meanwhile, law firm Bristows highlights the hurdles ahead for applicants.

Migraine & Hepatitis B Prevention Products Among New EU Filings

The latest list of marketing authorization applications under review by the European Medicines Agency includes filings for eight new products.




Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts