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AI Regulation: EU Network Announces Four-Year Action Plan

 
• By Eliza Slawther

Multiple guidance documents, a regulatory sandbox, and the creation of an “observatory” to monitor the emergence of new technologies are some of the actions being considered by the European medicines regulatory network under its AI regulatory system workplan.

Workplan
• Source: Shutterstock

The European medicines regulatory network – the group comprising the European Medicines Agency, the European Commission, and member states’ national competent authorities – has revealed a multi-annual workplan that will run until 2028 and, it hopes, lead to the creation of a regulatory system equipped to deal with the challenges and risks of artificial intelligence.

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AI Could Be Used ‘In The Deliberation’ Of HTA Reviews In England, Says NICE

 
• By Eliza Slawther

England’s health technology assessment institute, NICE, is looking to “reimagine” its evaluation process with the help of AI, rather than just using this technology to speed up its existing processes.

EMA’s Newly Qualified AI Tool To Boost MASH Market Dynamics

 
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US FDA Under Makary: MAHA With A Lighter Touch

 
• By Michael McCaughan

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More from Advanced Technologies

Gene Therapy Sponsor INTERACT, Pre-IND Meeting Confusion Lingers Despite FDA Guidance

 
• By Sue Sutter

PhRMA questioned whether proof-of-concept studies are needed before an INTERACT meeting and said a draft guidance describing the timing of definitive toxicology studies creates confusion.

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EU Pharmacopoeia Adopts ‘Groundbreaking’ Cell Therapy Chapter, Seeks Feedback On Alternative Microbiological Tests

 
• By Neena Brizmohun

A new chapter that will be published in the European Pharmacopoeia soon is expected to provide a comprehensive framework for the production and quality control of cell-based preparations. Meanwhile, an existing chapter has been revised to facilitate the implementation of rapid microbiological testing methods.