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List of stringent regulatory authorities. A stringent regulatory authority (SRA) is a national drug regulation authority which the World Health Organization (WHO) considers to apply stringent standards for quality, safety, and efficacy in its process of regulatory review of drugs and vaccines for marketing authorization. [1]
The regulation of therapeutic goods, defined as drugs and therapeutic devices, varies by jurisdiction. In some countries, such as the United States, they are regulated at the national level by a single agency. In other jurisdictions they are regulated at the state level, or at both state and national levels by various bodies, as in Australia.
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 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.
Title 21 is the portion of the Code of Federal Regulations that governs food and drugs within the United States for the Food and Drug Administration (FDA), the Drug Enforcement Administration (DEA), and the Office of National Drug Control Policy (ONDCP). [1] It is divided into three chapters: Chapter I — Food and Drug Administration
F. Federal Agency for Medicines and Health Products. Federal Commission for the Protection against Sanitary Risk. Federal Institute for Drugs and Medical Devices. Fimea. Food and Drug Administration (Myanmar) Food and Drug Administration (Taiwan) Food and Drug Administration. Food and Drug Board of Authority.
In March 2013, the former regulatory body was rebranded and restructured as the China Food and Drug Administration, elevating it to a ministerial-level agency. [2] In 2018, as part of China's 2018 government administration overhaul, the name was changed to 'National Medical Products Administration' and merged into the newly created State ...
In the 1980s, the European Union began harmonising regulatory requirements. In 1989, Europe, Japan, and the United States began creating plans for harmonisation. The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) was created in April 1990 at a meeting in Brussels.