Abstract

REGULATORY REQUIREMENTS FOR THE REGISTRATION OF DRUGS IN ASEAN COUNTRIES

V. Sudha Rani*, Lakshmi Priya, Y. Ratna Sindhu, Brahmaiah Bonthagarala, G. Ramakrishna and M. V. Naga Bhushanam

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Abstract

This article provides an overview of critical regulatory requirements to be considered for Association of Southeast Asian Nations (ASEAN) pharmaceutical markets and covers certificates of pharmaceutical products, regulatory submissions, pharmacopoeia, halal compliance, stability requirements, pharmacovigilance, product labeling, and drug variation information. The ASEAN region is emerging in the pharmaceutical marketplace with several countries leading in quality, efficacy, safety, BE/BA, and variations. It is important for the region to have more ASEAN countries accredited to PIC/S for the implementation and maintenance of harmonized cGMP standards and quality systems. In the author's experience, it would be good to have common filing procedures with full mutual acceptability in the ASEAN region.

Keywords: ASEAN Countries, Mutual Recognition Procedure (MRP), Decentralized Procedure (DCP) and Centralized Procedure (CP).