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  2. European Medicines Agency - Wikipedia

    en.wikipedia.org/wiki/European_Medicines_Agency

    The European Medicines Agency (EMA) operates as a decentralised scientific agency (as opposed to a regulatory authority) of the European Union (EU) and its main responsibility is the protection and promotion of public and animal health, through the evaluation and supervision of medicines for human and veterinary use. [8]

  3. Marketing authorisation - Wikipedia

    en.wikipedia.org/wiki/Marketing_authorisation

    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.

  4. List of stringent regulatory authorities - Wikipedia

    en.wikipedia.org/wiki/List_of_stringent...

    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 ...

  5. EudraLex - Wikipedia

    en.wikipedia.org/wiki/EudraLex

    Regulation of therapeutic goods; International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use; Good clinical practice; European Medicines Agency; EUDRANET; EudraVigilance; Title 21 of the Code of Federal Regulations (USA) Drug development

  6. Common Technical Document - Wikipedia

    en.wikipedia.org/wiki/Common_Technical_Document

    It was developed by the European Medicines Agency (EMA, Europe), the Food and Drug Administration (USA) and the Ministry of Health, Labour and Welfare (Japan) starting at World Health Organization International Conference of Drug Regulatory Authorities (ICDRA) at Paris in 1989. [1]

  7. Medicines and Healthcare products Regulatory Agency

    en.wikipedia.org/wiki/Medicines_and_Healthcare...

    The MHRA and the US Food and Drug Administration were criticised in the 2012 book Bad Pharma, [43] and in 2004 by David Healy in evidence to the House of Commons Health Committee, [44] for having undergone regulatory capture, i.e. advancing the interests of the drug companies rather than the interests of the public.

  8. Office of Global Regulatory Operations and Policy - Wikipedia

    en.wikipedia.org/wiki/Office_of_Global...

    FDA Building 32 houses the Office of the Commissioner and the Office of Regulatory Affairs. The Office of Global Regulatory Operations and Policy (GO), [1] also known as the Office of Regulatory Affairs (ORA), [2] is the part of the U.S. Food and Drug Administration (FDA) enforcing the federal laws governing biologics, cosmetics, dietary supplements, drugs, food, medical devices, radiation ...

  9. Regulation of therapeutic goods - Wikipedia

    en.wikipedia.org/wiki/Regulation_of_therapeutic...

    The European Union (EU) medicines regulatory system is based on a network of around 50 regulatory authorities from the 31 EEA countries (28 EU Member States plus Iceland, Liechtenstein and Norway), the European Commission and European Medicines Agency (EMA). EMA and the Member States cooperate and share expertise in the assessment of new ...