FORMULATION DOCUMENTATION AND APPROVAL OF AMANTADINE EXTENDED RELESE CAPSULES IN REGULATORY MARKET
Regulatory authorities and organizations play a vital role to meet the requirements of legal procedures related to drug development and life cycle maintenance processes in a country. Almost every country has its own regulatory authority, which is responsible to scope and implement the rules, regulations, and guiding provisions to regulate drug development, life cycle maintenance process, licensing, registration, manufacturing, marketing, and labeling of pharmaceutical products. United States Food and Drug Administration (USFDA), Medicines and Healthcare products Regulatory Agency, UK (MHRA), Pharmaceuticals and Medical Devices Agency, Japan (PMDA), Therapeutic Goods Administration, Australia (TGA), Central Drugs Standard Control Organisation, India (CDSCO), Health Canada, Canada (HC), South African Health Products Regulatory Authority, South Africa (SAHPRA), The National Health Surveillance Agency, Brazil (Agência Nacional de Vigilância Sanitária, ANVISA), European Medicines Agency, EU (EMA), National Medical Products Administration, China (NMPA), National Agency for Food and Drug Administration and Control, Nigeria (NAFDAC), Medicines and Medical Devices Safety Authority, New Zealand (MEDSAFE), Medicines Control Authority of Zimbabwe (MCAZ), Swiss Agency for Therapeutic Products, Switzerland (SWISSMEDIC), Ministry of Food and Drug Safety, Republic of Korea (MFDS), National Medicines Regulatory Authority, Sri Lanka (NMRA) are some of the regulatory authorities and organizations established in respective countries/region
16 , 2 , 2026
41 - 47
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