GMP News - Regulatory Affairs

In the beginning of September, the stimuli document "Proposed Definitions of Excipient Components- Revisions to 2018 Definitions- PF 49(5)" was published for comment on the website of the Pharmacopeial Forum of the USP. Comments on this draft can be submitted until 30 November 2023.

The FDA published the final guidance on annual status reports and other submissions for postmarketing requirements (PMRs). The reports are intended to facilitate submissions by drug and biological product application holders of complete and accurate information on PMRs and postmarketing commitments (PMCs) in a consistent format.

The FDA has published a draft guidance entitled “Postmarketing Approaches to Obtain Data on Under-Represented Populations in Clinical Trials”. The purpose of this document is to describe FDA requirements and provide recommendations for obtaining safety and effectiveness information on drug and biological products in the postmarketing setting in typically under-represented patient populations in clinical trials.

Critical inspection findings at a study center in India led the European Medicines Agency (EMA) to launch a referral process and to review potential implications for marketing authorizations in Europe. This followed a GCP inspection by the Spanish Agency for Medicines and Medical Devices (AEMPS), which raised serious concerns about the validity and reliability of the study data generated by the CRO.

On 19 July 2023, the EMA (European Medicines Agency) published a Reflection Paper on the use of Artificial Intelligence (AI) in the medicinal product  lifecycle. This document is open for comments until 31. December 2023. What is the content of the document?

The European Commission (EC) published an updated Version of the Questions & Answers relating to the EU Clinical Trials Regulation (CTR). In particular, chapter 11 on transitional trials has been deleted and a new guidance document has been developed.