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Information and advice on submitting a nutritional product to the Advisory Committee for Borderline Substances (ACBS).
The MHRA’s AI Airlock pilot phase ran between April 2024 and March 2025. This report does not constitute formal MHRA guidance.
Documentation to support changes made to reporting Manufacturer Incident Reports (MIRs) and Field Safety Corrective Action Reports (FSCAs) to the MHRA following implementation of the Medical Devices (Post-market Surveillance…
Information to help comply with ICH guidelines, if you are running clinical trials in the UK.
Recommendations for prescribing methadone and buprenorphine to people in treatment for opioid dependence in England.
Information about suspected side effects of e-cigarettes and how to report side effects.
Detailed information on the sources, quality and scope of the UK Clinical Research Delivery programme key performance indicators.
MHRA’s mechanism for evaluating the justifications supplied by applicant organisations who plan to utilise decentralised manufacture.
The MHRA have implemented a dual strategy for a risk-adapted approach to clinical trials in the UK.
Guidance on how to submit changes to labelling and patient information leaflets to MHRA.
Guidance for marketing authorisation holders on drafting direct healthcare professional communications (DHPCs)
Guidance on the steps manufacturers and suppliers can take to ease supply shortages.
How the MHRA decides whether to approve a clinical investigation for medical devices.
Actions QPs, RPis and RPs need to take following agreement of the Windsor Framework
The review of the safety of isotretinoin has concluded.
The MHRA's initial plans on an Early Access service, which will be developed further throughout 2025.
An overview of the legal requirements for children’s medicines that marketing authorisation holders (MAHs) need to abide by.
Sets out deliverables and timelines to support the development of safe In Vitro Diagnostic (IVD) medical devices.
How investigators and sponsors should manage clinical trials during COVID-19
VDEC’s Discovery and surveillance capabilities provide unique services across a spectrum of molecular immunology platforms.
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