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Guidance for industry on flexible approaches to regulation we are taking during the COVID-19 outbreak.
How to register your medical devices with the Medicines and Healthcare products Regulatory Agency (MHRA) for the markets in Great Britain and Northern Ireland
FDA trade union: trade union: annual returns, rules, statement to members, decisions and other related documents.
How to conform with the legal requirements for placing medical devices on the market.
How to apply for a clinical trial including eligibility, phases, model IMPDs, costs and how to make changes to your application.
What you need to do to place a medical device on the Great Britain, Northern Ireland and European Union (EU) markets.
What you need to know before you can place a medical device on the Great Britain market with a UKCA mark.
How to get fast-track approval of medical devices during COVID-19.
The MHRA has authorised cabotegravir as 30 mg tablets and as a 600 mg long-acting injection administered every two months
Find out which COVID-19 test products have been approved.
Guidance for organisations involved in any aspect of the pharmaceutical lifecycle or GLP studies regulated by MHRA, covering the approval of paper documents when working from home
How test manufacturers or distributors can apply for approval of their tests to sell on the UK market.
Guidance on how to license electronic cigarettes and other inhaled nicotine-containing products (NCPs) as medicines in the UK.
Information for healthcare professionals and the public about the Pfizer/BioNTech vaccine.
How the MHRA makes decisions on when a product is a medical device (borderline products), and which risk class should apply to a medical device.
Project Orbis is a programme to review and approve promising cancer drugs helping patients access treatments faster.
The MHRA has approved the combined antibiotic cefepime/enmetazobactam (Exblifep 2 g/0.5 g powder for concentrate for solution for infusion)
A new pathway supporting innovative approaches to the safe, timely and efficient development of medicines to improve patient access.
Advice for manufacturers of Class I medical devices for placing products on the UK market
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