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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 ...
The Drug Regulatory Authority of Pakistan (DRAP) is a self-governing entity under the Federal Government of Pakistan. It functions under the administrative supervision of the Ministry of National Health Services, Regulations & Coordination .
In addition, the Controlled Drugs and Substances Act specifies additional regulatory requirements for controlled drugs and drug precursors. [18] In Ontario, the Drug and Pharmacies Regulation Act governs "any substance that is used in the diagnosis, treatment, mitigation or prevention of a disease...in humans, animals or fowl." [19]
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The Central Drugs Standard Control Organisation (CDSCO) is India's national regulatory body for cosmetics, pharmaceuticals and medical devices. It serves a similar function to the Food and Drug Administration (FDA) of the United States or the European Medicines Agency of the European Union .
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.
The United States Food and Drug Administration (FDA or US FDA) is a federal agency of the Department of Health and Human Services.The FDA is responsible for protecting and promoting public health through the control and supervision of food safety, tobacco products, caffeine products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines ...
The National Drug Authority (NDA) is a government-owned organisation in Uganda, mandated to regulate drugs in the country, including their manufacture, importation, distribution, and licensing. [ 3 ] Overview