New Filings At The EMA
New medicines under evaluation at the European Medicines Agency.
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Mithra says its new oral contraceptive could be a major breakthrough in a “space where there hasn’t been any innovation in decades."
The regulatory agency also urges qualified persons at drug companies to let the agency know as soon as possible if they are finding that the new measures are not flexible enough to deal with the current logistical challenges quickly.
This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the European Union, and updates on EU marketing authorization changes recommended by the CHMP.