AI (Artificial Intelligence) is becoming an increasingly important topic in the pharmaceutical sector. On 7 January 2025, the FDA published a first draft of a Guidance for Industry 'Considerations for the Use of Artificial Intelligence to Support Regulatory Decision-Making for Drug and Biological Products'. The comment period ends on 7 April 2025. What is the FDA's focus here?
The European Medicines Agency (EMA) has published a new document entitled "Considerations regarding the implementation of ICH M13A on bioequivalence for immediate-release solid oral dosage forms".
The U.S. Food and Drug Administration (FDA) has published a guidance document to assist facilities that evaluate donors of human cells, tissues and cell-based products (HCT/Ps). This guidance provides comprehensive recommendations to establish compliance with donor screening and testing requirements.
During an inspection, the FDA found serious violations in the manufacture of an amniotic fluid-based product. An official warning letter lists, among other things, the lack of a licence for a medicinal product, violations of good manufacturing practices (CGMP) and misleading labeling - with potentially far-reaching consequences for the company.
The EU is advancing research to reduce PFAS in the healthcare sector in order to minimize environmental and health-related risks. A new Europe Horizon project aims to reduce emissions, develop safe alternatives and make the European healthcare sector more sustainable.
Chapters 3 and 6 of the Best Practice Guides (BPGs) for the Submission and Processing of Variations in the Mutual Recognition Procedure were once again updated in January 2025.
The European Medicines Agency published a concept paper on the development of a guideline on assessment and reporting of mechanistic models used in the context of model informed drug development (MIDD).
In the Pharmacopeial Forum, PF 51(2), a proposed revision of USP Chapter <1058> Analytical Instrument Qualification has been published for comments. The chapter provides general guidance in a scientific, risk-based approach for carrying out an analytical instrument and system qualification (AISQ). Comments can be submitted until 31 May 2025.
The GMP/GDP Inspectors Working Group decided at the end of 2023 to extend the validity of GDP and GMP certificates that expired at the end of the year until 2024 or until the next on-site inspection, whichever occurs first. It has now been clarified that from 2025, this extension no longer applies.
Aide-mmoires and checklists support a structured approach in GDP audits, ensuring that all relevant aspects are considered. In this article, we examine how these tools can be used effectively, the risks they may entail, and what auditors should pay special attention to.