A key lesson from the COVID-19 pandemic is that small, isolated clinical trials or compassionate use programmes in individual Member States may not provide sufficiently robust data for clear medical and public health recommendations. In light of these particular considerations, the EMA has published a draft Guidance on the Conduct of Clinical Trials during Public Health Emergencies for comment.
The European Medicines Agency (EMA) has launched three major new features of PRIME, the Agencys scheme to enhance support for the development of medicines targeting an unmet medical need.
The information and data obtained from pharmaceutical development form the basis for defining the specifications and manufacturing processes, including controls for an active substance or a medicinal product. What are the GMP requirements for research and development?
At the beginning of April, Issue 13.1 of the European Pharmacopoeia (Ph. Eur.) was published. It will be applicable as of 1 January 2027. Among other texts, it includes the revised general chapter 2.8.25 High-performance thin-layer chromatography of herbal products.
In April 2026, the updated texts of Ph. Eur. 13.1 were published and listed on the EDQM website under the Ph. Eur. section. These include, for example, the revised general chapter '2.1.7. Balances for analytical purposes'.
Following the revision of the ICH Q9 guideline 'Quality Risk Management 2023', the accompanying training material was also published. This has now been updated with regard to the two annexes. Annex I describes quality risk methods and tools, and Annex II describes possible applications of quality risk management (QRM).
The European Pharmacopoeia (Ph. Eur.) chapter 2.4.35 Extractable elements in plastic materials for pharmaceutical use has been revised. It will be effective as from 1 January 2027.
There are various guidelines on the topic of cleaning validation. A new addition is a technical guide from the Chinese National Food and Drug Administration Food and Drug Inspection Center. What does it cover?
The U.S. Food and Drug Administration has launched a new unified platform for analyzing adverse event reports. The AEMS platform represents a major achievement in the agency's mission to modernize and provide transparency into the safety of regulated products.
Amendments to the EU Commission Implementing Regulation (CIR) 520/2012 on the performance of pharmacovigilance (PV) activities came into effect in February 2026. These changes have practical implications for certain UK-authorised products, particularly with regard to PV requirements.