Bridging the European Regulatory Gap

Any regular commentary on the environment for the pharmaceutical industry in Europe is bound to have a predominantly negative tone, so it is a welcome change to be able to record a positive development in the regulatory context—and one that should make life a little easier for everyone involved in developing new medicines.

Starting July 1st, the European Medicines Agency is changing the way it provides scientific advice on the research and development of new medicines, including assistance on protocols. Sponsors can expect final advice after as little as 40 days, and certainly within 70 days—compared to the previous 100-day procedure. The experts will be involved earlier and more systematically. The agency's Scientific Advice Working Party is being expanded from 22 to 26 members.

And with the same attention to broadening the relevance and legitimacy of the advice, internal assessors will be backed up by more external experts. For example, the agency is introducing a formal peer review of advice before it is issued, to maximize clarity and to ensure consistency. It is also ensuring closer collaboration with academia, learned societies, and patient organizations.

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