Feedback sought on 'extensive' revisions to EU qualification/validation GMP for drugs
This article was originally published in SRA
The European Commission is seeking comments on a number of proposed revisions to the EU guidance on the qualification and validation of facilities, equipment, utilities and processes used for the manufacture of medicines1.
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New medicines under evaluation at the European Medicines Agency.
An advanced immunotherapy for recurrent glioblastoma and the first biosimilar version of Lucentis for age-related macular degeneration have also been submitted for review by the European Medicines Agency for potential pan-EU authorization.
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.