GMP News - Regulatory Affairs

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).

The European Commission published an updated Version 6.4 of the Questions & Answers (Q&As) relating to the EU Clinical Trials Regulation (CTR). A new Q&A has been added for the case where the sponsor of a clinical trial is not the product owner of the IMP and should not have access to the quality IMPD in order to protect commercially confidential information.

In February 2023, the U.S. FDA issued a Warning Letter (WL) to the US American company "Dunagin Pharmaceuticals Inc. dba Massco Dental" after having inspected its site in Arkansas in August/September 2022.