Pre-Phase III approval possible? EMA's faster adaptive licensing for drugs ready for testing
This article was originally published in SRA
The adaptive drug licensing procedure that the European Medicines Agency had announced it was contemplating as far back as early 2011 is finally ready for use by companies that wish to test the procedure, Guido Rasi, the EMA's executive director has told Scrip Regulatory Affairs1.
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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.
The Pink Sheet’s list of EU centralized approvals of new active substances has been updated to include two new products, including Alnylam Pharmaceuticals' Givlaari for treating acute hepatic porphyria. The list, which contains information dating back to January 2018, includes brand name, generic name, company, therapeutic indication, date of marketing authorization and product type (eg, medicine, vaccine, biologic).