第10回DIAアジア新薬カンファレンス

The Association of Southeast Asian Nations (ASEAN) was established in 1967 in Bangkok. ASEAN is becoming an important part of Asian economy during recent years. There are 10 member countries now. Although there has been great efforts to harmonize the regulatory requirements in those nations, there are still a few country specific requirements existing. It is essential to understand the regulatory requirements for new drug development in this region. The ASEAN Consultative Committee for Standards and Quality (ACCSQ) Pharmaceuticals Product Working Group (PPWG) has focused on the regulatory harmonization efforts for more than a decade. There have been progresses achieved during the past years. An expert with long experience of with APAC and ASEAN activities will introduce ASEAN regulatory environment as well as the most updated ASEAN regulatory harmonization activities. The experience with ASEAN country specific requirements for new drug development will be also shared. It will cover ACTR (ASEAN common technical requirement), ACTD (ASEAN CTD) and recent technical guidelines.