국산의약품의 동남아 시장진출을 위한 ASEAN의 의약품 허가 조화 체계에 관한 연구

Study on the ASEAN Harmonization System of Pharmaceutical Products for Export of Domestic Medicines into Southeast Asian Countries

BACKGROUND(OBJECTIVE) Association of South-East Asian Nations (ASEAN) has been emerged as the main export region of pharmaceutical products. Therefore, the cooperation with member countries of ASEAN has been emphasized and, it is necessary to understand ASEAN pharmaceutical regulatory guidelines for the growth of the pharmaceutical industry. METHODS This study investigated the regulatory guidelines adopted by ASEAN through the search of homepage, internet articles, and various regulatory information. RESULTS The main contents of ASEAN Common Technical Dossiers (ACTD) and ASEAN Common Technical Requirements (ACTR) published were presented. They were implemented by all members of ASEAN countries even though there was a slight difference in implementation timing and content. The differences as well as common features of regulatory guidelines among ASEAN member countries were presented. Detail description on regulatory agency, certificate of a pharmaceutical product (CPP), product labelling, and official product approval timelines were also described. International pharmacopoeia such as USP, BP, EP, and JP were legally recognized in ASEAN. Pharmacovigilance and risk management plans in ASEAN followed the ICH guidelines without specific requirements. The cooperation on regulatory harmonization has been continued. Especially joint assessment procedure, formal procedure including simultaneous marketing authorization application to ASEAN member countries and joint assessment reports, will be implemented in the near future. CONCLUSION Understanding and monitoring for ASEAN regulatory guideline will help make the export of domestic pharmaceutical products to the ASEAN region faster and more efficient.