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Reports, analysis and official statistics
Consultations and strategy
Data, Freedom of Information releases and corporate reports
Clinical trial applications that need expert advice from a specialist group or committee.
Information about the MHRA graduate scheme which is currently closed for applications.
Project Orbis is a programme to review and approve promising cancer drugs helping patients access treatments faster.
There are changes to the legislation on reference medicinal products (RMPs) used to support abridged marketing authorisation applications.
The MHRA will review applications for orphan designation at the time of a marketing authorisation (MA) or variation application.
UK guideline on GMP for decentralised manufacturing, ensuring compliance with EU GMP principles for safe, quality medicinal products.
Information about how to register your homeopathic medicinal product through the Simplified Homeopathic Registration Scheme or the UK Homeopathic National Rules Scheme
Reporting, investigating and recalling suspected defective medicinal products to the Defective Medicines Report Centre (DMRC).
Information for manufacturers on the regulations that apply to prosthetic, orthotic and ophthalmic devices.
Information for healthcare professionals on how pulse oximeters are regulated, home use and issues to look out for when using the devices
How to register as a manufacturer, importer or distributor of active substances.
How to submit your periodic safety update report report (PSUR) or periodic benefit risk evaluation report (PBRER)
The MHRA provides advice for Retailers and Producers of e-cigarette / vape products.
Directory of current ICH Guidelines which have been implemented by the Medicines and Healthcare products Regulatory Agency.
The MHRA have implemented a dual strategy for a risk-adapted approach to clinical trials in the UK.
Details of the process changes for established medicines, effective from 1 March 2024, which apply specifically to chemical products.
There are different regulations which apply to devices and equipment including hand gels and PPE (personal protective equipment)
How to renew marketing authorisations for products granted through different routes and at different times.
Information on applying for New Active Substance Work Sharing Initiative (NASWSI) and Biosimilar Work Sharing Initiative (BSWSI) assessments and list of approved products.
How the MHRA makes decisions on whether a borderline product is a medical device and whether medical devices regulations should apply.
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