In January 2026, the Q&A document 'Questions and Answers regarding co-processed excipients used in solid oral dosage forms (H & V)' was finally published on the EMA website.
On 17 October 2025, the European Commission published two new GMP-implementing regulations for veterinary medicinal products in the Official Journal of the European Union. These will come into force on 16 July 2026. What should companies be considering now?
According to the USP, steam treatment is one of the most widely used methods for microbial decontamination of herbal drugs. Can it be used to decontaminate medical cannabis?
In December 2025, updated documents on the topic "Variations" were published on the HMA/CMDh website. These include, for example, Chapter 7 "CMDh BPG on Variation Worksharing" of the "Best Practice Guides (BPGs) for the Submission and Processing of Variations in the Mutual Recognition Procedure" and the "EMA/CMDh Explanatory notes on Variation Application Form - Human medicinal products only."
In a recent Warning Letter, the U.S. FDA criticised inadequate cleaning of non-dedicated equipment. However, cleaning of dedicated equipment was also criticised. What did the FDA find?
Draft versions of the Ph. Eur. chapters on rubber closures and non-plasticised PVC materials have been published in Pharmeuropa Issue 38.1. The deadline for comments is 31 March 2026.
In March 2025, the FDA identified serious GMP deficiencies during an inspection of a US manufacturer of sterile OTC products and contract testing laboratories. After the manufacturer's response to the Form 483 report was deemed insufficient, a Warning Letter was issued.
The guidelines for the implementation of Commission Regulation (EU) 2024/3190 have been published in form of a question and answer document. They are intended to assist in the implementation of the regulation on the use of bisphenol A (BPA) and other bisphenols and bisphenol derivatives in materials that are intended to come into contact with food.
The European Directorate for the Quality of Medicines & HealthCare (EDQM) has published two new documents on herbal food supplements, one targeting healthcare professionals, the other consumers.
The ICH published the E22 Draft guideline on "General Considerations for Patient Preference Studies" together with a concept paper for a new ICH E23 Guideline on "Considerations for the Use of Real-World Evidence (RWE)". Read more about the two ICH guidelines.