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Guidance for Applicants wishing to apply for a Promising Innovative Medicines designation, pre-submission meeting or an EAMS Scientific Opinion.
A new pathway supporting innovative approaches to the safe, timely and efficient development of medicines to improve patient access.
How to apply for a clinical trial including eligibility, phases, model IMPDs, costs and how to make changes to your application.
Employment Appeal Tribunal judgment of Gavin Mansfield Deputy Judge of the High Court on 25 July 2024.
Explains control of advertisement regime.
Information on how to notify the MHRA of your intention to carry out a clinical investigation for medical devices.
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.
How to show MHRA you're meeting good clinical practice (GCP) standards and what to expect from an inspection.
Information for patients, healthcare professionals and developers of new medicines
This toolkit is for Innovation Passport holders following the Innovative Licensing and Access Pathway (ILAP) and provides activities to support the design and development of medicines.
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