Greater Civil Society Involvement in Drug Evaluation Will Bring Challenges, Warns EMA Deputy Head
The European Medicines Agency is keen to highlight its landmark policy on proactive publication of clinical data but it’s aware of the challenges involved in this and other transparency initiatives.
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The European Medicines Agency and the EU Heads of Medicines Agencies network are working together on a broad range of subjects, from big data to the availability of medicines… and of course, Brexit.
Novimmune and Biogen encountered surprises, challenges and opportunities with PRIME, the European Medicines Agency’s new priority medicines scheme. The two companies have some advice on how to keep pace with expectations under the initiative and make the most of the scheme for taking drugs for unmet medical needs to patients faster.
The European Medicines Agency says it has been disappointing to see previously rejected applications for its PRIME scheme sent back to the agency with no additional data. On the other hand, the scheme, which is designed to get drugs for unmet medical needs to patients faster, is going from strength to strength. Kick-off meetings are identifying issues that sometime surprise companies but can be dealt with early on, well before a product is filed for authorization.