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Home » EMA Updates Guidelines for Postmarket Studies and Variations
EMA Updates Guidelines for Postmarket Studies and Variations
July 21, 2017
The European Medicines Agency updated its guidelines for postmarketing variations, safety studies and quality changes.
The documents include a new checklist for type II variation applications — which cover any changes that may affect a product’s quality, safety or efficacy, that are not extensions to a labeled indication — as well as 15 new questions-and-answers on postmarket clinical trial requirements.
The checklist outlines dozens of validation steps for submitting a type II variation application to the EMA, designed to help authorization holders avoid the most common mistakes — such as not supplying the proper contact information, signatures and appropriate annexes and appendices.
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