How and to what extent comparative efficacy studies are useful in the development of biosimilars has been discussed many times. The ICH has now published a concept paper on this topic with plans to publish draft guidelines in 18 months.
The new UK regulations for clinical trials will take effect on 28 April 2026. For clinical trials of investigational medicinal products (IMPs), the research ethics committee (REC) application must include any document providing evidence of insurance to cover the sponsor's or investigator's liability. What are the GCP responsibilities for insurance review?
The EMA published the comments on the draft ICH Guideline E21 on the inclusion of pregnant and breastfeeding individuals in clinical trials in a consolidated tabular overview. The comments received will now be discussed and implemented by the expert group.
The USP is changing the official date of the revised USP Talc monograph from 1 December 2025 to 1 June 2026. In addition to the previous two-year implementation period for this monograph, this will provide stakeholders with an additional six months to implement the changes.
At the beginning of December 2025, the draft of the 8th revision of the "GUIDELINE ON REQUIREMENTS FOR REVISION/ RENEWAL OF CERTIFICATES OF SUITABILITY TO THE EUROPEAN PHARMACOPOEIA MONOGRAPHS' was published on the EDQM website in the 'Newsroom Certificate of suitability" section and is open for comment until 16 January 2026.
In November and December 2025, the Questions & Answers (Q&A) document European Medicines Agency post-authorisation procedural advice for users of the centralised procedure, which addresses topics that may be relevant after marketing authorisations has been granted, was updated and published on the website of the European Medicines Agency (EMA).
The U.S. Food and Drug Administration has issued a Warning Letter to an API manufacturing site in India. Since 2023, approximately 1,500 laboratory incidents (including OOS results and major analytical events) have been recorded, and the authority identified systemic failures in the handling of Out-of-Specification (OOS) results, laboratory investigations, and the overall CAPA system.
VDI/ÖFR/SWKI-MT 6022 Sheet 8.1 is now the valid version for the qualification of personnel for the cleaning of air conditioning systems and air ducts. The new sheet closes the gap between Sheet 2 (training categories) and Sheet 8 (implementation of air conditioning system cleaning) and defines the binding competencies, training content, examinations and evidence that the personnel carrying out the work and the training providers must fulfil. Read More.
A Canadian drug manufacturer received a warning letter due to its GMP deficiencies. Among other things, deviations from 21 CFR 211.67 (a) were found. What did the FDA criticise?
What are some typical GMP deficiencies that the FDA has found during inspections with regards to technical issues in recent years? Find out more.