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Information about when you need to submit substantial amendments to a clinical trial including changes to the trial sponsor or legal representative, Investigational medicinal product certification and importation.
UK guideline on GMP for decentralised manufacturing, ensuring compliance with EU GMP principles for safe, quality medicinal products.
How marketing authorisation holders should inform MHRA of a signal or an ADR to a medicine.
This publication clarifies which regulatory guidelines should be followed, and which apply, in the development of phage therapeutic products.
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 …
Information for clinicians and patients.
Also covering requests for waivers or deferrals and concerning the operation of the compliance check.
Guidelines to help mitigate and manage medicine shortages.
Clinical trials Route B substantial modifications pilot starts on 1 October 2025. Prepare for the implementation of new regulations from 28 April 2026.
The MHRA is part of the Access Consortium along with the Therapeutic Goods Administration, Health Canada, Health Sciences Authority of Singapore and Swissmedic.
Guidance on how to license electronic cigarettes and other inhaled nicotine-containing products (NCPs) as medicines in the UK.
Reporting, investigating and recalling suspected defective medicinal products to the Defective Medicines Report Centre (DMRC).
Reforms to ensure that medical device regulation is fit for purpose for software products, including artificial intelligence (AI).
Information for patients, healthcare professionals and developers of new medicines
A list of herbal ingredients which are banned or restricted for unlicensed medicines.
Information for wholesale dealer licence holders about the medicines put on the UK market for UK patients that they cannot export or hoard.
Information about ensuring blood and blood component safety.
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.
Information on sourcing medicines that can be supplied by wholesale distributor authorisation (WDA) holders based in the UK.
Guidelines to provide developers of biosimilar products with a clear outline of the requirements in Great Britain.
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