GMP News - Regulatory Affairs

In March 2023, the EDQM once more prepared its "CERTIFICATION MONTHLY REPORT" on the topic of "CEPs" and has now published it in the newsroom of the EDQM website.

The MHRA published their GCP Inspections Metrics Report, covering the period from 1 April 2019 to 31 March 2020. Critical observations were related e.g. to data integrity, IMP management, protocol compliance, and pharmacovigilance.

Following the previously published FDA guidance on externally controlled trials, the agency issued a Framework for the use of Digital Health Technologies (DHT).

The European Medicines Agency added a disclaimer to the Reflection paper on the use of interactive response technologies (interactive voice/web response systems) in clinical trials, with particular emphasis on the handling of expiry dates to address its applicability regarding the European Clinical Trials Regulation (CTR).

The EMA issued an updated Questions and Answers document with information about the previously announced raw data proof-of-concept (PoC) pilot for industry. Will the Raw Data Analysis lead to more GCP Inspections?

The two proposed USP General Chapters <660> and <661.2> have been published for comment in the current issue of Pharmacopeial Forum. The deadline for comments is May 31, 2023.

The HMPC issued a concept paper on the revision of the Guideline on declaration of herbal substances and herbal preparations in herbal medicinal products (HMPs).