New EMA Questions and Answers Document on Post Approval Change Management Protocols

The detailed guidelines for the various categories of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products (2010/C 17/01) require that the marketing authorisation holder (MAH) has to keep a document describing all changes planned during the life cycle of the medicinal product. The post approval change management protocol - approved by the regulatory authority - enables an early evaluation of the strategy for the change of the MAH. It is expected to lead to faster and more predictable implementation of post-approval changes.

To clarify frequently asked questions, the European Medicines Agency has published a Questions and Answers document on its position regarding the following 8 topics:

• What is a Post Approval Change Management Protocol?
• What should be in the content of a post approval change management protocol?
• What is the mechanism for the submission and evaluation of a Post approval Change Management Protocol?
• How will the change be implemented after all the studies described in the approved protocol have been performed?
• Can applicants submit post approval change management protocols for any type of change?
• Can a post approval change management protocol cover multiple changes?
• Where should the requested documents (description of change/change management protocol) be placed in the application?
• Are post approval change management protocols applicable to all types of applications?

Please see the EMA Questions and answers on post approval change management protocols for more information as well as the detailed guidelines for the various categories of variation. You will find statements on post approval change management protocol on pages 14, 31 and 37.

Author:
Dr Gerhard Becker
CONCEPT HEIDELBERG (a service provider entrusted by the ECA Foundation)