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WHO . Draft Guidelines on GCP
The WHO has recently published a draft guideline, including two annexes, on Good Clinical Practice (GCP) for clinical trials involving medicinal products. Comments on these documents may be submitted until 6 September 2026 Access the documens here: Guidelines for Good...
Product Management Services (PMS) – Implementation of International Organization for Standardization (ISO) standards for the identification of medicinal products (IDMP) in Europe
After the release of version 2 of this guideline, important discussions took place which led to significant changes in the information provided. As a result, version 3 of this document has been completely revised, and previous versions should no longer be taken into...
AI Omnibus enters into force
On 27 July 2026, the AI Omnibus enters into force across the EU, bringing extended timelines to administrative simplification. The AI Omnibus, proposed as part of the digital omnibus package on 19 November 2025, delivers a targeted simplification of the AI rulebook...
EU CTR Q&A Version 7.3 is Out
The European Commission and EU agencies have officially released Version 7.3 of the EU Clinical Trials Regulation (CTR) Q&A guidance. You can download the full, updated guidance directly from here
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