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More informationThe Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024: guidance on implementation Medical devices: periodic safety update report (PSUR)
Out now
Open for consultation
Released January 2025
Final guidance released
An at-a-glance summary of news from around the agency
11th and 12th February 2025
Blog post by Essam Kerwash The International Council for Harmonisation (ICH) M15 Model informed Drug development (MIDD) Guideline has reached Step 2b and is available for public consultation. As a clinical pharmacology assessor at the UK Medicines and Healthcare products Regulatory Agency (MHRA), I was involved with the development of this guidance.
A suite of guidance has been published by the Medicines and Healthcare products Regulatory Agency (MHRA).
Out now!