GMP News Drug Safety/Pharmacovigilance

The U.S. Food and Drug Administration (FDA) issued a discussion paper on "Using Artificial Intelligence and Machine Learning in the Development of Drug and Biological Products." In particular, the FDA wants to receive feedback on the key areas in the context of AI/ML, including Good Machine Learning Practice (GMLP).

The EMA has published on its website an updated overview with recommendations for the use of herbal medicinal products (HMPs) in children.

The USP has recently published a revision of its Chapter <87> "Biological Reactivitiy Tests, In Vitro" for comments. One of the objectives is a better alignment with other relevant USP chapters.

The proposed USP General Chapter <1031> The Biocompatibility of Pharmaceutical Packaging Systems and their Materials of Construction has been published for comment in the current issue of Pharmacopeial Forum. It outlines a risk-based approach to biocompatibility evaluation.

In March 2023, the WHO published the first draft of the guideline "WHO good manufacturing practices for excipients used in pharmaceutical products" on its website for comments. The public comment period ends on 26 May 2023.

The response to the consultation on reforming the UK clinical trials regulation has been published. According to the press release, a series of new measures will be introduced by the UK Medicines and Healthcare products Regulatory Agency (MHRA).

The FDA issued a new version of the draft guidance on electronic systems in clinical Investigations. The document provides additional recommendations on the risk-based approach to validation of electronic systems.