Abstract

REGULATORY REQUIREMENTS FOR REGISTRATION OF DRUGS IN ASEAN COUNTRIES

J. Sai Bhavana*, M. Venkata Sowmya, Brahmaiah Bonthagarala, G. Ramakrishna, M. V. Nagabhushanam and D. Nagarjuna Reddy

Abstract

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. This will ensure rapid patient access to drugs, such as seen in the EU with Mutual Recognition Procedure (MRP), Decentralized Procedure (DCP) and Centralized Procedure (CP). Economic diversity, language, uneven distribution of wealth, intellectual property, and lack of harmonization of guidelines and their implementation are some of the challenges currently creating hurdles for pharmaceutical companies looking to penetrate these regions more effectively.

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