News about GMP/cGMP


EMA Q&A regarding OOS-batches of ATMPs

The European Medicines Agency’s (EMA) Committee for Advanced Therapies (CAT), together with the GMDP Inspectors Working Group and the Blood Products Working Party, released a Q&A document on how companies should handle OOS batches of authorized cell or tissue-based advanced therapy medicinal products (ATMPs). For manufacturers, importers and Marketing Authorisation Holders of ATMPs this 2-page document will be of good value.

Six pairs of questions and answers explain a possible pathway for the administration of such out-of-specification (OOS) batches that have already been granted a marketing authorisation. The overall goal is to avoid an immediate significant hazard to the patient:

“The supply of an OOS batch can only occur when the conditions laid down in Section 11.5 of the ATMP-Guidelines are met, in particular that the manufacturer provides an evaluation of the risks to the treating physician and that the supply of the batch is requested by the treating physician after having considered the specific condition of the patient and the evaluation of the risks provided by the manufacturer”, it is stated.

Answers are given, e.g., on the following questions:

  • Who should be notified and when?
  • Are National Competent Authorities involved?
  • How should the manufacturer/importer/MAH notify the EMA of the OOS batch(es)?
  • What are the obligations or expectations the manufacturer/importer/MAH should follow?
  • What information should be provided to the patient?

Click here for direct access to the 2-page Q&A.