12th DIA Asia New Drug Conference in Japan

In ASEAN, the regulatory environment is changing very fast. The dynamic regulatory requirement brings challenges to the industry. In 2017, the pharmaceutical law in Vietnam has been updated and implemented. Industry is trying to digest the new requirements in this regulation and the speaker form DAV will give the explanation on the key updates in the new regulation. In addition, there will be another presentation from industry perspective. The session explores the ASEAN pharmaceutical environment from the onset of the ASEAN Consultative Committee for Standards and Quality (ACCSQ) Pharmaceutical Product Working Group (PPWG), Technical Working Groups (TWG), Implementation Working Group (IWG) and ASEAN guidelines. Providing insights on the latest development in PPWG, updates and future area of guidance discussion. Discussing the challenges faced by industry members and opportunities for industry in creating favourable regulatory environment in expediting approval of innovative medicines for patients in ASEAN.