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The National Agency for Food and Drug Administration and Control (NAFDAC) is a Nigerian federal agency under the Federal Ministry of Health that is responsible for regulating and controlling the manufacture, importation, exportation, advertisement, distribution, sale, and use of food, drugs, cosmetics, medical devices, chemicals, and packaged water.
It is the largest and most up-to-date source of information on drug products approved for use in Nigeria by NAFDAC (National Agency for Food & Drug Administration & Control). The use of EMDEX as a reference drug manual is endorsed by the Pharmacists Council of Nigeria , the Nursing & Midwifery Council of Nigeria , and major health institutions.
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 ...
However, additional specifications may be applied in national and continental contexts. In the United States, the Food and Drug Administration (FDA) layers additional specifications onto its requirements for eCTD submissions, including PDF, transmission, file format, and supportive file specifications.
National Agency for Food and Drug Administration and Control (NAFDAC) National Primary Health Care Development Agency (NPHCDA) Nigerian Institute of Medical Research (NIMR) Nigeria Centre for Disease Control (NCDC) National Drug Law Enforcement Agency (NDLEA)
This process is performed within a legal framework defining the requirements necessary for successful application to the regulatory authority, details on the assessment procedure (based on quality, efficacy and safety criteria), and also the circumstances where a marketing authorisation already granted may be withdrawn, suspended or revoked. [1]
This policy was later challenged in court following FDA approval of a food coloring manufactured with a compound known to be carcinogenic, after separate testing indicated that the food coloring itself did not cause cancer in test animals. The United States Court of Appeals for the Sixth Circuit upheld the FDA's approval of the food coloring. [36]
Africa Food Safety Forum (AFSF) [1] African Food Safety Network (AFoSaN) [2] The Food Safety and Quality Authority of The Gambia (FSQA) [3] Tanzanian Food and Drugs Authority (TFDA) [4] Ethiopian Food and Drug Authority (EFDA) [5] Moroccan National Office of Food Safety (ONSSA) [6] South African National Regulator for Compulsory Specifications ...