The development of new drugs requires extensive research in the areas of manufacturing controls, chemistry, preclinical trials and clinical trials. To obtain Marketing Authorization Application (MAA) approval for a new drug, different countries must adhere to various regulatory standards. Before a drug can be granted market approval, it must pass through clinical trials to ensure its safety, efficacy and quality control of new drug products to serve public health. Each country has its own regulatory authorities that are responsible for enforcing rules and regulations and issuing guidelines to regulate the marketing of drugs. Given the existing conditions, this study endeavors to express the drug approval process and regulatory requirements according to the United States Food and Drug Administration (USFDA) in the USA, Central Drugs Standard Control Organization (CDSCO) in India and European Medicines Agency (EMA) in Europe.
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