EMA To Speed Up Orphan Approvals By Closing Gap Between CHMP, COMP Opinions
The European Medicines Agency has initiated steps to ensure that the opinions issued by its human medicines evaluation committee and the orphan drugs committee for certain types of innovative orphan drugs reach the European Commission at around the same time. While the move is expected to facilitate an earlier decision on the marketing authorization applications of such products, industry says it does not go far enough.
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Companies are being encouraged to become “early adopters” of the EU Clinical Trials Information System when it goes live in December 2021.
Drug companies will be able to “play around” with the new EU Clinical Trials Information System in a secure testing environment before it goes live in approximately 15 months.