The European Shortages Monitoring Platform (ESMP) started with the full scope of functionalities. All MAHs are obliged to only use this platform to report data on medicine shortages and availability issues.
A new EDQM guide is designed to help business operators producing food contact materials (FCMs) and articles prepare the documentation required to support the compliance and safety of their products.
In January 2025, the U.S. FDA has published in its newsroom on the CDER website the article called "Determining Recommended Acceptable Intake Limits for N-nitrosamine Impurities in Pharmaceuticals: Development and Application of the Carcinogenic Potency Categorization Approach".
The US Food and Drug Administration (FDA) has identified serious violations of Current Good Manufacturing Practice (CGMP) regulations during a review of documents submitted by Akron Formulations India Private Limited, a manufacturer of OTC products.
In January 2025, version 3 of the IPEC Guide "Good Distribution Practices Guide for Pharmaceutical Excipients" was published on the IPEC website (International Pharmaceutical Excipients Council Europe (IPEC Europe) asbl).
Following the first guidelines on continuous manufacturing (ICH, FDA), the WHO has now also published its first paper on the topic, initially as a draft.
Due to the revision of the ICH Q9 document on quality risk management, the ICH has also published comprehensive training material on the main text. However, even the revised version of the ICH Q9 (R1) document still has two annexes. Training slides that the ICH published as a Briefing Package in 2006 are still available on the ICH website, though. Is the "Briefing Package" still up to date?
The FDA issued a Request for Information (RFI) on industry practices related to opiate alkaloid content of poppy seeds. The agency is particularly interested in information about Good Agricultural Practices (GAP).
A new USP chapter <1120> Ensuring Microbiological Quality of Articles of Botanical Originis (ABOs) is being proposed by the Joint Subcommittee on Microbiological Issues in Dietary Supplements and Food Ingredients. It provides information on practices to prevent and methods to treat microbiological contamination.
The Regulation on licensing and monitoring the handling of cannabis for scientific purposes under the German Consumer Cannabis Act has been published. Which authority is responsible?