Essentials of Drug Regulatory Affairs in the EU - pharmastarter

Classification of changes

What impact does a change have on quality, safety, and efficacy?

Variations are classified into four different categories. The higher the risk of impact on the quality, safety, and efficacy of a medicinal product, the higher the classification of the variation.

The Variation Regulation (Regulation 1234/2008/EC) describes the four different types of variations. One of the tasks of the regulatory affairs department is to classify each variation. The correct classification of variations is a complex process.