GMP News Drug Safety/Pharmacovigilance

The FDA issued a new version of the draft guidance on electronic systems in clinical Investigations.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.

The EMA published the final updated EU herbal monograph on Hypericum perforatum L. including associated supporting documents and an overview of the comments received.

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.

The FDA has stopped accepting submissions to the Voluntary Cosmetic Registration Program (VCRP) effective March 27, 2023. This follows the agency's plans to develop a program for submission of the facility registrations and product listings mandated by the "Modernization of Cosmetics Regulation Act" (MoCRA). According to the agency, the new law gives the FDA new authorities that will help ensure the safety of cosmetic products.

A risk mitigation plan is available to help CTIS users carry out regular activities within the system in different risk scenarios. In case of system failure and persistent system downtime, submissions of clinical trials data, assessment and supervision of authorized trials outside CTIS should be allowed.

EMA's Query Management Working Group prepared a document to address the main questions received from sponsors about CTIS and the Clinical Trials Regulation.