(2002; 166 pages)
Regional harmonization initiatives - the Association of South-East Asian Nations (ASEAN)
Dr Mohd. Zin Che Awang, Malaysia
The idea of harmonizing ASEAN pharmaceutical regulations was first raised in the ASEAN Consultative Committee for Standards and Quality (ACCSQ), which was formed in 1992 to facilitate and complement the Asian Free Trade Area (AFTA). In 1997, ACCSQ authorized the ASEAN regulatory bodies to work towards eliminating technical barriers to trade.
The proposal for pharmaceutical harmonization in ASEAN was agreed by the Senior Economic Officials Meeting (SEOM) in early 1999. Subsequently, a Pharmaceutical Product Working Group (P-PWG) was formed to develop harmonization schemes for pharmaceutical regulations in the ASEAN member countries, without compromising product quality, safety or efficacy. The countries currently participating in the P-PWG are Brunei Darussalam, Cambodia, Indonesia, Lao People’s Democratic Republic, Malaysia, Myanmar, Philippines, Singapore, Thailand and Viet Nam. Malaysia has been assigned as the lead country. P-PWG comprises regulatory and industry representatives, and five meetings have been held since 1999.
The scope of the ASEAN Harmonization Project includes exchange of information on existing regulatory requirements, which vary from country to country, comparative studies on them, and study of other successful models for harmonization (particularly ICH). By consolidating the common technical requirements (CTR) developed by each individual country, a common technical dossier (CTD) is established in order to implement the harmonized ASEAN Pharmaceutical Product Dossier.
The P-PWG has made considerable progress despite limitations in existing capabilities and capacities. It is committed to ensuring the quality, safety and efficacy of pharmaceutical products in the interest of consumers and of public health. The ongoing tasks are to improve global cooperation in pharmaceutical harmonization via an interactive and constructive forum; to implement, monitor and review CTDs in line with current international requirements; to establish mutual acceptance of data and facilitate the development of a single ASEAN pharmaceutical market.
Trade globalization highlights the need for a strategic partnership in pharmaceutical harmonization, with the adoption of ICH as a model. The ASEAN P-PWG will maintain close links and network with various international agencies, particularly WHO, in working towards adopting a harmonized best-practice approach appropriate to the ASEAN pharmaceutical environment.