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The List is associated with the Wikipedia page Guidances for statistics in regulatory affairs that aims to address the various topics of the listed guidances. Regulatory guidances (draft and/or final ) are subject to revisions. Therefore, users of the guidances are advised to consult the original website to check for the latest version.
Regulatory affairs (RA), is a profession that deals with an organization’s adherence to regulatory compliance.. It is a position mostly found within regulated industries, such as pharmaceuticals, medical devices, cosmetics, agrochemicals (plant protection products and fertilizers), energy, banking, telecom etc. Regulatory affairs also has a very specific meaning within the 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.
Community Health Accreditation Program(CHAP) DNV GL Healthcare; Foundation for the Accreditation of Cellular Therapy (FACT) [4] Global Healthcare Accreditation (GHA) [5] Healthcare Facilities Accreditation Program (HFAP) Healthcare Quality Association on Accreditation (HQAA) Institute for Medical Quality (IMQ) Joint Commission (TJC)
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 ...
Examples of regulatory bodies include the European Medicines Agency (EMA) in Europe, the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom, the Institute for Quality and Efficiency in Health Care (IQWiG) in Germany, the Food and Drug Administration (FDA) in the United States, and the Pharmaceuticals and Medical ...