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In December 2025, the "Questions & Answers (Q&A)" document relating to centralized authorization procedures was updated again and published on the website of the European Medicines Agency (EMA). The updates and changes mainly relate to chapters 2 and 5 of the list of questions "European Medicines Agency pre-authorization procedural advice for users of the centralized procedure."

In December, the FDA published a Warning Letter to a manufacturer of OTC products, in which it identified deficiencies in both the handling of microbiological deviations and the validation of alternative rapid microbiological methods. The testing and analysis of raw materials used for contamination was also inadequate.

In January 2026, the U.S. FDA issued a Warning Letter to the Indian company "Chemspec Chemicals Private Limited" after having inspected its site in July/August 2025. The observation mentioned in the Warning Letter is related to the lack of Quality Oversight, Good Documentation Practices and Data Integrity principles.

The FDA inspected a US manufacturer of OTC products and found the water system to be deficient. Along with other observations, this has now led to a Warning Letter.