Petra Dörr: EDQM Appoints First New Director In 14 Years
The European Directorate for the Quality of Medicines & HealthCare, which is responsible for the European Pharmacopoeia, is to be led by former Swissmedic regulator and current World Health Organization executive Petra Dörr.
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The European Pharmacopoeia, which has been updated to reflect regulatory and scientific advances, contains 114 new monographs including substances of “high therapeutic interest.” Holders of CEPs have been advised to update their certificates in line with the new monographs.
The Pink Sheet's list of EU centralized approvals of new active substances has been updated to include six new products, including bluebird bio's Skysona, the first gene therapy approved in the EU to treat early cerebral adrenoleukodystrophy.
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.