GMP News - Regulatory Affairs

The passages amended in the last update of the Q&A document of the EMA/CMDh refer, among other things, to the no longer required setting of temporary acceptable intake limits for nitrosamines. This has important consequences for marketing authorisation holders for the feedback of nitrosamine impurities to the authorities.

The sponsor may support the investigator by contracting service providers. However, it is emphasized that the investigator is still responsible for any outsourced tasks.

The USP adopted the revised general chapters <1724> Semisolid Drug Products - Performance Tests and <1912> Measurement of Yield Stress of Semisolids. In particular, chapter <1724> now also includes information on in vitro permeation tests (IVPTs).

Supplement 11.3 to the European Pharmacopoeia (Ph.Eur.) is now available and will be implemented on 1 January 2024. According to the EDQM timetable, this supplement will be followed by versions 11.4 to 11.8, with the final implementation date planned for July 2025.

The agency issued a draft guidance providing information for marketing authorization holders of human prescription drugs who are required to conduct postmarketing studies or clinical trials, commonly referred to as postmarketing requirements (PMRs). In case of PMR Noncompliance the MAH could be subject to an FDA warning letter.

EMA's GCP Inspectors Working Group added a new Question & Answer in the section on "Records of Study Subject Data Related to Clinical Trials" of the GCP Q&As. What are the considerations when direct remote access of health data is required in a clinical trial?

The FDA has issued a new guidance together with a Guidance Snapshot which describes the agency's current thinking regarding adjusting for covariates in the statistical analysis of randomized clinical trials. According to the FDA, Sponsors should adjust for baseline covariates that are strongly associated with an outcome in a clinical trial population.