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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.
The Medicines and Healthcare Products Regulatory Agency (MHRA) is the UK government agency which is responsible for ensuring that medicines and medical devices work and are acceptably safe. [ 43 ] Global Justice Now and Stop AIDS Campaign published a report claiming patients could not always afford drugs where the public sector had partly ...
The UK started a temporary Committee on Safety of Drugs while they attempted to pass more comprehensive legislation. Though compliance and submission of drugs to the Committee on Safety of Drugs was not mandatory immediately after, the pharmaceutical industry later complied due to the thalidomide situation. [citation needed]
The agency ran a London bus advertising campaign entitled "Nice People Take Drugs" in 2009, [4] but it was pulled a few days later, amidst claims of censorship by the advertising regulators. [5] Release remains the UK's only dedicated free legal and drugs advice service, offering a helpline for drug users and their families. Staffed by lawyers ...