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What you need to do to place a medical device on the Great Britain, Northern Ireland and European Union (EU) markets.
Project Orbis is a programme to review and approve promising cancer drugs helping patients access treatments faster.
FDA trade union: trade union: annual returns, rules, statement to members, decisions and other related documents.
The Medicines and Healthcare products Regulatory Agency regulates medicines, medical devices and blood components for transfusion in the UK. MHRA is an executive agency, sponsored by the Department of Health and Social Care .
Guidance for industry on flexible approaches to regulation we are taking during the COVID-19 outbreak.
A new pathway supporting innovative approaches to the safe, timely and efficient development of medicines to improve patient access.
How to get fast-track approval of medical devices during COVID-19.
The Medicines and Healthcare products Regulatory Agency (MHRA), US Food and Drug Administration (FDA) and Health Canada have collaborated to identify five guiding principles for the development of predetermined change control plans (PCCPs). These guiding principles for PCCPs aim to...
How to register your medical devices with the Medicines and Healthcare products Regulatory Agency (MHRA) for the markets in Great Britain and Northern Ireland
The new recognition routes open additional options for the MHRA to bring cutting-edge medicines faster to UK patients by leveraging the expertise and decision-making of trusted regulatory partners
Guidance on how to license electronic cigarettes and other inhaled nicotine-containing products (NCPs) as medicines in the UK.
How to conform with the legal requirements for placing medical devices on the market.
How to notify the MHRA of your intention to carry out a clinical investigation for medical devices.
Rules for FDA.
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