The European Medicines Agency has opened a public consultation on a new draft chapter of the Data Quality Framework for EU medicines regulation.
Published on 19 October 2026, the document addresses the collection, management and submission of adverse drug-reaction reports for both human and veterinary medicines.
The consultation remains open until:
14 December 2026.
Although the document is primarily about pharmacovigilance data quality, it contains an unusually clear regulatory statement about the use of artificial intelligence in safety-data management.
The European medicines regulatory network is preparing a more coordinated framework for artificial intelligence across the medicines lifecycle.
Summary notes published by EMA on 14 October 2026 confirm several important developments:
a newly established AI Guidance Coordination Group;
planned horizontal guidance on good machine-learning practice;
dedicated AI guidance for clinical development;
continued EMA–FDA work on common AI terminology;
greater attention to AI-ready regulatory data infrastructure.
These developments are strategically important because pharmaceutical AI guidance has so far emerged through several separate initiatives. [Read more…]
Posted by aiforpharma at
21:47:09
in News, Insights
The UK Medicines and Healthcare products Regulatory Agency has placed artificial intelligence at the centre of its five-year regulatory strategy.
Published on 14 October 2026, the MHRA Strategy 2030 describes how the Agency intends to modernise medicines and medical-device regulation in response to rapid advances in artificial intelligence, data science, personalised medicines and advanced therapies.
The significance of the strategy is not simply that MHRA supports innovation. [Read more…]
Posted by aiforpharma at
21:44:49
in News, Insights