Member countries of the Association of South East Asian Nations (ASEAN) have agreed to harmonize existing pharmaceutical regulations in the region, with the aim to help free trade in the region. Delegates from all over ASEAN convened at the 16th ASEAN consultative committee for standards and quality-pharmaceutical product working group (ACCSQ-PPWG) meeting in Manila last May 25-29, 2009. This is in alignment with the objective of the ASEAN Free Trade Area (AFTA).
In their press statement, the group was tasked to develop transparent and fair regulatory processes and standard regulatory requirements, and eliminate duplicate studies to meet different regulatory requirements, in order to provide more efficient use of resources in the R&D process of drug development.
Rationalizing the standards will cut down actual costs on documentation during product creation and registration, thus bringing down the expenses for drugs in the pipeline.
ACCSQ-PPWG co-chairman Yuppadee Javroongrit said that consumers will have better choices of drugs that adhere to the same quality standard once the region will have implemented the free trade scheme in early 2010.
ACCSQ-PPWG website:
http://www.aseansec.org/14903.htm
Additional Resources:
ASEAN Roadmap for Healthcare Sector Integration (pdf)
Javroongrit. 2004. ASEAN harmonization updates (ppt)
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