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The MHRA is divided into three main centres: [citation needed] MHRA Regulatory – the regulator for the pharmaceutical and medical devices industries; Clinical Practice Research Datalink – licences anonymised health care data to pharmaceutical companies, academics and other regulators for research
A stringent regulatory authority is a regulatory authority which is: a) a member of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), being the European Commission, the US Food and Drug Administration and the Ministry of Health, Labour and Welfare of Japan also represented by the Pharmaceuticals and Medical Devices Agency (as before ...
Marketing Authorisation Application (MAA) is an application submitted by a drug manufacturer seeking marketing authorisation, that is permission to bring a medicinal product (for example, a new medicine or generic medicine) to the market.
It is run by the Medicines and Healthcare products Regulatory Agency (MHRA) and the Commission on Human Medicines. It was extended to hospital pharmacists in 1997, and to community pharmacists in 1999. [2] The Yellow Card Centre Scotland is a joint venture between MHRA and the Scottish Government. [3]
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The Clinical Practice Research Datalink (CPRD) is an observational and interventional research service that operates as part of the Department of Health and Social Care.It is jointly funded by the National Institute for Health and Care Research (NIHR) and the Medicines and Healthcare products Regulatory Agency (MHRA).
In 2012, at the margins of the 65th World Health Assembly conference in May the Minister of Health of Brazil proposed an agenda to create a new coalition of Heads of Agency "to address current and emerging human medicine regulatory and safety challenges globally, strategically and in an ongoing, transparent, authoritative and institutional manner."
products.mhra.gov.uk A Product Licence Number (or PL code for short) is a unique identifier on the packaging of medicines, used to uniquely identify the product. This code will normally remain the same despite the varying marketing and branding of the companies selling it.