‘No Turning Back’ On Regulatory Changes at UK MHRA
Industry’s Role Praised By Innovation Minister
The UK medicines regulator has a “unique opportunity” to evaluate the systems it operates and to “do things differently", according to its long-term interim head, June Raine.
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A list of EU biosimilar filings, CHMP opinions and EU marketing authorizations, including details of the biosimilar company, the brand name/INN, indication(s), the reference product/company, and the date and type of event.