In general, a drug approval process comprises of various stages: application to conduct clinical trials, conducting clinical trials, filing of Registration Dossier/ New Drug Application (NDA) and post-marketing studies. Therefore, the knowledge of exact and detailed regulatory requirements for MAA of each country should be known to establish a suitable regulatory strategy.Ī regulatory process, by which a person/organization/sponsor/innovator gets authorization to launch a drug in the market, is known as drug approval process. The single regulatory approach for marketing authorization application (MAA) of a new drug product applicable to various countries (on the basis of single dossier) is utmost difficult.
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