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Reforms to ensure that medical device regulation is fit for purpose for software products, including artificial intelligence (AI).
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 approach the MHRA intends to take for products approved or pending in decentralised procedure (DCP) or mutual recognition procedures (MRP).
A list of herbal ingredients which are banned or restricted for unlicensed medicines.
Detailed information on the sources, quality and scope of the UK Clinical Research Delivery programme key performance indicators.
The locations for a Marketing Authorisation Holder (MAH) and a Qualified Person responsible for Pharmacovigilance (QPPV)
Information for patients, healthcare professionals and developers of new medicines
Information about how approved bodies help regulate medical devices and how to apply for approval.
Information and recommendations for manufacturers on the preparation and presentation of a periodic safety update report (PSUR).
Information on the implementation of changes to pharmacovigilance for medicines authorised in the UK following the agreement of the Windsor Framework.
Apply for and maintain registrations for the brokering of human medicines.
Information about how to register your homeopathic medicinal product through the Simplified Homeopathic Registration Scheme or the UK Homeopathic National Rules Scheme
Every year the MHRA receives requests for its staff to speak at conferences and other events across the world.
Information and recommendations for manufacturers on the preparation and presentation of a post market surveillance report (PMSR).
The following guidance has been jointly developed by the Heath Research Authority (HRA) and MHRA, in consultation with the Information Commissioners Office (ICO), on behalf of the UK.
How the MHRA makes decisions on whether a borderline product is a medical device and whether medical devices regulations should apply.
A flyer to circulate to customers alongside a field safety notice covering what it is and why it's important to take action.
Information on the implementation of changes to the licensing of medicines for human use in the UK following the agreement of the Windsor Framework.
Guidance on the steps manufacturers and suppliers can take to ease supply shortages.
This publication clarifies which regulatory guidelines should be followed, and which apply, in the development of phage therapeutic products.
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