Nitrosamines
The European Medicines Agency (EMA) has published the sixth revision of the Appendix 1 (“Acceptable intakes (AIs) established for N-nitrosamines”) of the EMA Questions and answers for marketing authorization holders/applicants on the CHMP Opinion for the Article 5(3) of Regulation (EC) No 726/2004 referral on nitrosamine impurities in human medicinal products (EMA/409815/2020 Rev.21). Nitrosamines are […]
When is a biological product interchangeable with a reference product?
The US FDA has issued a draft guidance for industry entitled ‘Considerations for Demonstrating Interchangeability with a Reference Product: Update.’ This draft guidance describes considerations regarding a switching study or studies intended to support a demonstration that a biological product is interchangeable with a reference product. FDA issued the guidance for industry ‘Considerations in Demonstrating […]
Real world data
The role of real-world data (RWD) and real-world evidence (RWE) in supporting the evaluation of medicines across the different stages of their development and lifecycle is evolving. To reflect this, the International Conference on Harmonisation (ICH) has released a reflection paper on ‘pursuing opportunities for harmonisation in using real-world data to generate real-world evidence, with […]
Testing for bacterial endotoxin using recombinant technology
The United States Pharmacopeia (USP) has approved bacterial endotoxin testing using non-animal derived reagents, based on recombinant technology. The USP Microbiology Expert Committee has approved the inclusion of Chapter <86> ‘Bacterial Endotoxins Test Using Recombinant Reagents’, which permits the use of non-animal-derived reagents for endotoxin testing, to the United States Pharmacopeia–National Formulary (USP–NF). The final […]
Withdrawn FDA guidances
The U.S. FDA has withdrawn several guidances relating to biologics during the course of 2024. These include: The full list can be found here.
US Regulatory Submissions
Under section 745A(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), at least 24 months after the issuance of a final guidance document in which the Food and Drug Administration (FDA or Agency) has specified the electronic format for submitting submission types to the Agency, such content must be submitted electronically and in […]
Artificial intelligence
The EMA has published guiding principles that set how EU medicine regulators can use large language models (LLMs), a form of generative AI, focusing on text generation in regulatory science and for regulatory activities. Artificial intelligence is a general term referring to any machine-based system designed to operate with varying levels of autonomy and that […]
European consultation on plastics and pharmaceuticals
Plastic additive 18 (P-EPQ) is a phenolic antioxidant that may be used as a stabiliser in the processing of plastic materials. It consists of seven components, all of which contribute to the efficiency of the additive. However, it is a product-by-process (reaction product) rather than a physical mixture. It comprises one main component and the […]
Container Content for Injections
The United States Pharmacopeia chapter 〈697〉 ‘Container Content for Injections’ is being revised. This proposal is based on the version of the chapter official as of May 1, 2015. The United States Pharmacopeia is the coordinating pharmacopeia for the international harmonisation of the compendial standards for this chapter, as part of the process of international […]