The EMA has published a revised version of the guideline on the implementation of the European Medicines Agency policy on the publication of clinical data for medicinal products for human use.
The European Medicines Agency has announced the implementation of various ICH guidelines. Gaps that were previously covered by European documents will also be closed by supplementary papers. Moreover, the EMA has set up dedicated websites for the implementaion of the ICH E6, M11 and M12 guidelines.
The USP is expanding the Extractables and Leachables (E&Ls) Chapter Series <1664>: The draft chapter <1664.2> Parenteral Drug Products (Intramuscular, Intravenous, and Subcutaneous), has just been officially published.
The new general chapter "<1037> Process Analytical Technology-Theory and Practice" and the two related stimuli articles "Process Analytical Technology I-Theory of Sampling in PAT" and "Process Analytical Technology II-Implementation of Real-Time Release Testing" of the USP have been published on the website of the Pharmacopeial Forum for comments.
In a recent Warning Letter, the U.S. Food and Drug Administration (FDA) criticizes major analytical GMP violations observed during an inspection at a Chinese drug manufacturing facility. These include a lack of release testing and unsupported expiry dates for products intended for the U.S. market.
The Q&A document "Questions and answers for marketing authorisation 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", which was prepared jointly by the EMA and the CMDh, has been updated once again and published in the new revision 22 on the EMA website.
A US company received a Warning Letter because of problems at their CMO. FDA points out that companies should have a robust qualification process for CMOs.
Revisions to USP Chapters <761> Nuclear Magnetic Resonance Spectroscopy and <1761> Nuclear Magnetic Resonance SpectroscopyTheory and Practice were proposed for comment in PF 49(5) and are scheduled to become official on 1 December 2025. The USP has now identified other documentary standards that reference these chapters and has published a list of monographs that will be revised accordingly.
The guideline 'Additional guidance on the assessment on the risk assessment for presence of N-nitrosamines in APIs', first published in February 2020, has now been revised by a subgroup of the 'APIC Nitrosamines Task Force' and recently published in its latest version on the APIC website. The document is now called 'Nitrosamine Risk Management: Guidance for API Manufacturers' and has been extensively updated.
A Warning Letter was issued to a Dutch company, also because root cause determinations and CAPAs were deemed inadequate.