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Detailed guidance, regulations and rules
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 on applying for New Active Substance Work Sharing Initiative (NASWSI) and Biosimilar Work Sharing Initiative (BSWSI) assessments and list of approved products.
The MHRA is part of the Access Consortium along with the Therapeutic Goods Administration, Health Canada, Health Sciences Authority of Singapore and Swissmedic.
How to determine if you will need to undertake a clinical investigation of a medical device, or if it is exempt under the regulations.
How the MHRA makes decisions on whether a borderline product is a medical device or a medicinal product.
The locations for a Marketing Authorisation Holder (MAH) and a Qualified Person responsible for Pharmacovigilance (QPPV)
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 …
Details of how Marketing Authorisation Holders can provide information on planned or potential future submissions, to the MHRA.
Every year the MHRA receives requests for its staff to speak at conferences and other events across the world.
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 how to license electronic cigarettes and other inhaled nicotine-containing products (NCPs) as medicines in the UK.
This guidance clarifies the expectations on the application of the further pharmacovigilance provisions set out within the updated CIR 520/2012 for UK authorised products.
Sets out medicines that can be moved to Northern Ireland to meet patient need.
Information for patients, healthcare professionals and developers of new medicines
Transitional arrangements and timelines for acceptance of CE marked medical device in Great Britain.
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.
Sets out the payment due from members of the voluntary scheme for branded medicines pricing, access and growth in 2026.
Examples of what manufacturers must report to the MHRA under the medical device vigilance system when incidents involving their devices occur in the UK.
Information about how approved bodies help regulate medical devices and how to apply for approval.
Links to EU guidance, as it stood immediately before end of transition period.
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