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The Innovative Devices Access Pathway (IDAP) pilot is designed to accelerate the development of innovative medical devices that meet an unmet clinical need in the NHS and support their integration into the UK market.
Safety leaflet on epilepsy medicines and pregnancy to help patients and their families understanding the risks.
Information about how approved bodies help regulate medical devices and how to apply for approval.
Cancel a marketing authorisation, traditional herbal registration or parallel import product licence or withdraw a pending submission.
Information and advice on submitting a nutritional product to the Advisory Committee for Borderline Substances (ACBS).
Apply for and maintain registrations for the brokering of human medicines.
Guidance on infant and follow-on formula, the application form for infant and follow-on formula made from protein hydrolysates, and forms to notify the authority.
Documentation to support changes made to reporting Manufacturer Incident Reports (MIRs) and Field Safety Corrective Action Reports (FSCAs) to the MHRA following implementation of the Medical Devices (Post-market Surveillance…
The MHRA have implemented a dual strategy for a risk-adapted approach to clinical trials in the UK.
Points to consider when using real-world data in clinical studies
Guidance for industry on flexible approaches to regulation we are taking during the COVID-19 outbreak.
Guidance on how to submit changes to labelling and patient information leaflets to MHRA.
The review of the safety of isotretinoin has concluded.
How the MHRA treats traditional herbal medicines and homeopathic medicines.
How we engage and involve patients and the public in our regulatory decision-making.
Information about how to register your homeopathic medicinal product through the Simplified Homeopathic Registration Scheme or the UK Homeopathic National Rules Scheme
A list of herbal ingredients that are banned or restricted for unlicensed medicines.
By streamlining decision-making, the MHRA–NICE aligned pathway will help patients access new medicines 3–6 months sooner.
Information for patients, healthcare professionals and developers of new medicines
Outlining the principles for the management and oversight of the import of investigational medicinal products (IMPs) to Great Britain from listed countries.
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