Ranjith, Y and Janodia, Manthan D and Jagadish, PC and Bhat, KM and Karande, Swati and Udupa, N (2012) Scenario of Generic Drug Regulations for ASEAN Countries. Inventi Rapid: Pharmacy Practice, 2012 (3). pp. 1-8. ISSN 0976-3848

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Abstract

South East Asia is a growing pharmaceutical market. The regulatory environment has similar characteristics but drug registration requirements and processes differ among the countries. An Association of South East Asian Nations (ASEAN) initiative to harmonize the requirements for drug registration is in progress and there will be a single ASEAN market by 2015. ASEAN pharmaceutical market mostly depends on imports to meet the demand of health facilities and through development of ACTD they have provided a single window for drug approval in all 10 countries. Even though ACTDformat is mandatory from 2009 the member countries have their own requirements for registration process like administrativedocuments, labeling. The purpose of this paper is to give a comparative overview on the Drug market regulation in ASEAN countries and consequently facilitate proper understanding of main critical issues, differences and similarities of the related Drug regulations. In fact each legal system has different requirements but there is also a similar outline which consists of common rules and topics involving registration procedure, labeling, licensing, and product safety requirements. Therefore this review will try to focus on some main issues of the Drug regulations throughout a very practical approach.

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