EMA Updates Guidance on Three Post-Authorisation Activities

Regulatory News

The European Medicines Agency (EMA) announced Friday it has updated three post-authorisation activity guidance documents, including type II variations, post-authorisation safety studies and quality variations.

"The main aim is to improve the quality of post-authorisation applications by better assisting applicants in complying with the legal and regulatory requirements and avoiding frequent mistakes," EMA writes.

Specifically, the updates include a new pre-submission checklist for type II variations and updated questions and answers guides for post-authorisation safety studies and classifying quality changes to marketing authorisations.

In the type II variation pre-submission checklist, EMA lists more than 100 items sponsors should have checked off before submitting a type II variation application to ensure the submission is complete.

The document also lists elements that could prevent the start of the procedure in bold and italic text. EMA notes the elements that are not emphasized can help with validation or assessment, but can be communicated during validation and will not delay the procedure.

For post-authorization safety studies, EMA has added 15 new questions and answers "to provide marketing authorisation holders with detailed information on the submission requirements, assessment and implementation of outcomes for protocols, protocol amendments and final study reports of non-interventional impost [post-authorisation safety studies]."

EMA also has added eight new questions and answers to help sponsors determine how quality-related changes to a marketing authorisation should be classified, such as the introduction of a new manufacturing site, or submitting information about a new working cell bank or reference standard for a biological medicine.

 EMA