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GMP News

04.11.2025

What Requirements does the new Annex 22 place regarding Personnel?

The new draft of Annex 22 on artificial intelligence contains requirements for handling AI models in the GMP environment. It also describes requirements for employees who use these AI models.

04.11.2025

UK Clinical Trials Regulations: Six-Month Countdown

On 28 April 2026, significant updates to the UK clinical trials regulations will come into force. According to the MHRA, this will speed up research that could lead to new and better treatments for patients.

04.11.2025

Clinical Trials - Update on the CTIS

The Clinical Trials Coordination Group has summarized the experience of applicants and, in particular, national regulatory authorities with approval and amendment applications submitted via the CTIS. In addition, the German BfArM has now set up its own website with the most common (avoidable) deficiencies in the submission of an initial application or a major change.

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