EMA Updates Guidelines for Postmarket Studies and Variations

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.