GMP News - Regulatory Affairs

In the middle of February, the document "QWP Questions and Answers (Q&A): how to use a CEP in the context of a Marketing Authorization Application (MAA) or a Marketing Authorization Variation (MAV)" prepared by the EMA, the CHMP (Committee for Medicinal Products for Human Use) and the CVMP (Committee for Medicinal Products for Veterinary use) was published on the EMA website for the first time.

The EMA has received a grant of ten million euros from the European Commission to support regulatory systems in Africa, and in particular for the setting up of the African Medicines Agency (AMA).

Swissmedic's nitrosamine Q&A document "Update of the requirements for dealing with nitrosamine impurities in medicinal products" was updated in January 2024 and is now available in the new version on the Swissmedic website.

In January, the question and answer catalogue "RPM for PLM (Regulatory Procedure Management for the Product Lifecycle Management) - Frequently Asked Questions and Answers" was published on the EMA website. In addition to the glossary, it contains 23 questions and their answers relating to the use of the IRIS system.

Following recent cases of microbially contaminated ophthalmic drug products as well as safety recalls, the FDA published a revised draft guidance on Quality Attributes for Ophthalmic Drug Products, to include information about product sterility and preservative use. Moreover the revision clarifies that the guidance applies to all ophthalmic drugs, including over-the-counter (OTC) drugs and combination products.

The list of available reference standards is revised and published at regular intervals on the website of the EDQM. This comprises more than 3100 substances, including not only chemical reference substances but also herbal reference standards and biological reference preparations as well as reference spectra for carrying out tests and trials in accordance with Ph. Eur. methods.

Following the draft guideline published in March 2022 the FDA issued the final guidance that provides industry, investigators and others with recommendations on the use of digital health technologies (DHTs) to acquire data remotely from participants in clinical trials.