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The certificate of pharmaceutical product (abbreviated: CPP) is a certificate issued in the format recommended by the World Health Organization (WHO), which establishes the status of the pharmaceutical product and of the applicant for this certificate in the exporting country; [1] it is often mentioned in conjunction with the electronic Common Technical Document (eCTD).
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 Indonesian Food and Drug Authority (Indonesian: Badan Pengawas Obat dan Makanan, lit. 'Food and Drug Supervisory Agency'), Badan POM/BPOM, or Indonesian FDA is a government agency of Indonesia responsible for protecting public health through the control and supervision of prescription and over-the-counter pharmaceutical drugs (medication), vaccines, biopharmaceuticals, dietary supplements ...
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 ...
Headed by Directorate General of Health Services(India).CDSCO regulates pharmaceutical products through Drugs Controller General of India (DCGI) at chair. [citation needed] Drugs are classified under five headings. Under retail and distribution: [citation needed] Schedule X drugs - narcotics; Schedule H and L - injectables, antibiotics ...
Title VI establishes the Reagan-Udall Foundation for the Food and Drug Administration as a nonprofit corporation to advance the mission of the FDA to modernize product development, accelerate innovation, and enhance product safety. It requires the Foundation to: (1) identify unmet needs in the development, manufacture, and evaluation of the ...
Note: Most subscribers have some, but not all, of the puzzles that correspond to the following set of solutions for their local newspaper. CROSSWORDS
Food and Drugs Authority logo Food and Drugs Authority building. The Food and Drugs Authority (or FDA, formerly known as the Food and Drugs Board) is a Ghanaian government agency responsible for the inspection, certification, and proper distribution of foods and food products as well as drugs in Ghana.The FDA exists to ensure the safety, quality and efficacy of human and veterinary drugs, food ...