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


SMEs Making The Most Of EU Centralized Procedure And Scientific Support From EMA

Executive Summary

Smaller biopharmaceutical firms are increasingly making use of the EU’s centralized approvals procedure and the EMA’s scientific advice and other support services, and are also proving to be keen users of the agency’s priority medicines scheme (PRIME), accounting for half of all PRIME applications in 2016.

You may also be interested in...

New EU Action Plan To Boost Innovation By Smaller Firms

A new action plan from the European Medicines Agency is intended to promote innovation in SMEs by raising awareness of the regulatory tools and support available from the agency, offering more training and education, and promoting collaboration among SMEs, academia, and other stakeholders.

EMA’s PRIME A Year On: Hits And Misses When It Comes To Applications

Three out of four applications have been denied entry to the European Medicines Agency’s priority medicines (PRIME) scheme for getting drugs for unmet medical needs to patients faster. Robert Hemmings, who chairs the EMA’s scientific advice working party, explains why.

On The Rise In The EU: New Drug Applications, Conditional Approval Recommendations

Applications to the European Medicines Agency are continuing to rise, with orphan drugs playing a part in the increase, but the numbers of drugs for new pediatric indications and those for use outside the EU are still lamentably low. For the first time in five years, the CHMP issued no negative opinions, but more applications for accelerated assessment were rejected than accepted.





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