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A new pathway supporting innovative approaches to the safe, timely and efficient development of medicines to improve patient access.
Change your protocol, update your authorisation, report safety issues, submit safety updates and complete your end-of-trial study report.
The Advisory Group on Military and Emergency Response Medicine (AGMERM) provides specialist advice to the Ministry of Defence on the medical aspects of defence against chemical, biological and radiological threats. AGMERM works with the Ministry of Defence .
How to apply for a clinical trial including eligibility, phases, model IMPDs, costs and how to make changes to your application.
Directory of current ICH Guidelines which have been implemented by the Medicines and Healthcare products Regulatory Agency.
You must get permission to export certain drugs and medicines.
Information on herbal medicines, how to apply for a traditional herbal registration (THR), banned or restricted herbal ingredients, homeopathic medicines and fees.
Information for patients, healthcare professionals and developers of new medicines
Details of the process changes for established medicines, effective from 1 March 2024, which apply specifically to chemical products.
Information for wholesale dealer licence holders about the medicines put on the UK market for UK patients that they cannot export or hoard.
Guidance on how to license electronic cigarettes and other inhaled nicotine-containing products (NCPs) as medicines in the UK.
Information on granted EAMS scientific opinions, including the public assessment report and treatment protocols.
How we evaluated pre-exposure prophylactic (preventative) treatments for COVID-19.
An overview of the process including submitting or fast tracking an application, naming your medicine and paying fees.
The medicines regulators from Australia, Canada, Singapore, Switzerland and the United Kingdom (Access Consortium) have discussed the continued need for COVID-19 medicines that are safe, effective and of high quality
Information and documents on Public Health England’s review of the evidence for dependence on, and withdrawal from, prescribed medicines.
Report a problem ('adverse incident') with a medical device or medicine to MHRA using the Yellow Card Scheme
Update about the developing role of biosimilar medicines in the NHS in England and the safe, effective and consistent use of biosimilar medicines.
Apply for an import certificate to import a medicinal product into the UK for veterinary use.
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