A recently issued USP stimuli article describes advances in product quality and performance tests for topical and transdermal delivery systems (TDS). In particular, the article focuses on physicochemical and structural characterization tests for semisolid drug products.
More and more authorities are trying to create regulations for the production of new technologies by publishing guidelines. In this case, the European Medicines Agency (EMA) is asking for assistance in developing a guideline on the manufacturing of mRNA vaccines.
The European Commission (EC) published an updated Version of the Questions & Answers relating to the EU Clinical Trials Regulation (CTR). In particular, chapter 11 on transitional trials has been deleted and a new guidance document has been developed.
The USP revised the general chapter <1079.1> Storage and Transportation of Investigational Drug Products. With the revision reference is made to the new USP Chapter <1079.3> Monitoring Devices - Time, Temperature, and Humidity which will become official on 1 December 2023.
The Clinical Trials Coordination Group (CTCG) has published a Best Practice Guidance for sponsors of multinational clinical trials with different protocol versions approved in different Member States under the CTD that need to be transitioned to the EU CTR.
The FDA Center for Devices and Radiological Health (CDRH), which is also responsible for medical devices, has published tips on how to comment on guidance documents issued by the CDRH. What does it say?
End of January 2023 you could already read about a 3.5 page position paper from Notified Bodies regarding their perspective on hybrid audits of medical device and IVD manufacturers. The position paper has now been updated.
In August 2023, the U.S. FDA issued a Warning Letter to the US American company "Cosmobeauti Laboratories & Manufacturing Inc." after having inspected its site in March 2023. The significant violations of cGMP regulations for drug products, which are mentioned in the Warning Letter, can be checked here.
The World Health Organization (WHO) has published a draft working document entitled WHO Biowaiver Project - Prioritization exercise of active pharmaceutical ingredients for cycle VI (2024) and preliminary results from cycle V (2023). The deadline for submitting comments is 10 September 2023.
The German Federal Cabinet has adopted the draft of an "Act on the Controlled Use of Cannabis and on the Amendment of Further Regulations" (Cannabis Law - CanG).