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Guidance on how to complete your Electronic Application Form (eAF) and Cover Letter
Reforms to ensure that medical device regulation is fit for purpose for software products, including artificial intelligence (AI).
The MHRA is part of the Access Consortium along with the Therapeutic Goods Administration, Health Canada, Health Sciences Authority of Singapore and Swissmedic.
An interpretation of the good manufacturing practice (GMP) requirements for specials manufacturers.
The MHRA’s AI Airlock pilot phase ran between April 2024 and March 2025. This report does not constitute formal MHRA guidance.
Guidance on defining intended purpose for Software as a Medical Device (SaMD), to help SaMD manufacturers in meeting their statutory obligations.
The Early Access to Medicines Scheme (EAMS) aims to give patients with life threatening or seriously debilitating conditions early access to medicines that show early signs of having a major advantage over existing therapeut…
Outlining the principles for the management and oversight of the import of investigational medicinal products (IMPs) to Great Britain from listed countries.
Information about ensuring blood and blood component safety.
Since, April 2024, the MHRA has been using Lorenz DocuBridge for eCTD management in product licence submissions. This change is part of the modernisation of the MHRA’s Legacy Systems and is one of the initial tools launched …
The review of the safety of isotretinoin has concluded.
Guidance on infant and follow-on formula, the application form for infant and follow-on formula made from protein hydrolysates, and forms to notify the authority.
Sets out medicines that can be moved to Northern Ireland to meet patient need.
Information for wholesale dealer licence holders about the medicines put on the UK market for UK patients that they cannot export or hoard.
Recommendations for prescribing methadone and buprenorphine to people in treatment for opioid dependence in England.
How the MHRA treats traditional herbal medicines and homeopathic medicines.
Information and recommendations for manufacturers on the preparation and presentation of a periodic safety update report (PSUR).
The MHRA accepts an Active Substance Master File and/or a Certificate of Suitability in both new national initial Marketing Authorisation Applications (MAA) and in Marketing Authorisation Variation (MAV) applications.
Phase 2 of the Airlock will include seven additional technologies spanning AI-powered clinical note taking, advanced cancer diagnostics, eye disease detection tools, and obesity treatment support systems.
Also covering requests for waivers or deferrals and concerning the operation of the compliance check.
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