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In 1999, the Medicines Control Agency (MCA) took over control of the General Practice Research Database (GPRD) from the Office for National Statistics. The Medicines Control Agency (MCA) and the Medical Devices Agency (MDA) merged in 2003 to form MHRA. In April 2012, the GPRD was rebranded as the Clinical Practice Research Datalink (CPRD).
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.
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 ...
A Covid-19 vaccine developed by Valneva has been given regulatory approval by the Medicines and Healthcare products Regulatory Agency (MHRA). The UK had been due to receive 100 million doses of ...
In most countries, a marketing authorisation is valid for a period of 5 years. After this period, one should apply for renewal of the marketing authorisation, usually by providing minimal data proving that quality, efficacy and safety characteristics are maintained and the risk-benefit ratio of the medicinal product is still favourable.
In October 2024, the UK's Medicines and Healthcare products Regulatory Agency approved sugemalimab as part of a first-line combination treatment for lung cancer. [12] The approval was granted to CStone Pharmaceuticalsn under brand name Eqjubi. [ 13 ]
Tesla's stock price reached $420 on Wednesday afternoon, which elicited responses from social media users and the company's CEO, Elon Musk. "As foretold in the prophecy," Musk wrote in an X post ...
New year, new you? Discover the top New Year’s resolutions for pet owners in 2025 and beyond