Lecture on Worldwide Regulatory procedure EUROPE, UK, TGA, Canada, Japan, Russia[CIS], ASEAN
Автор: rajashri ojha
Загружено: 2021-05-13
Просмотров: 4963
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WORLDWIDE REGULATORY BODIES OVERVIEW
Drugs play important role in the health and economy of a country.
Pharmaceutical drugs are available from number of source.
To ensure that that they meet prescribed standards.
To ensure the safety, efficacy and quality of drugs as well as accuracy and appropriateness of the drug information available to the public.
Key Function of Drug Regulatory Agency
Product registration.
Regulation of drug manufacturing, importation , and distribution.
Adverse drug reaction monitoring.
Licensing of premises & persons & practices.
Main goal of the agency is to guarantee the safety , efficacy, and quality of the available drug product.
Types of Market Authorization Procedure:
Centralized Procedure[CP]
Decentralized Procedure [DCP]
Nationalized Procedure [NP]
Mutual Recognition Procedure [MRP]
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