ASEAN Aims to Harmonize Pharmaceutical Regulations

The Association of Southeast Asian Nations (ASEAN) countries gathered for five days from May 25-29, 2009 for the 16th Meeting of the ASEAN Consultative Committee for Standards and Quality-Pharmaceutical Product Working Group (ACCSQ PPWG). The event was held in the Philippines, and was hosted by the Philippines Bureau of Food and Drugs (BFAD). At this meeting, drug regulatory agencies of ASEAN countries agreed to harmonize standards and regulations of pharmaceutical products. The three principle aims are to (1) create a transparent regulatory process, (2) standardize regulation requirements, and (3) remove the need for duplicate studies to meet various regulation requirements, thereby allowing drug companies more time and resources that can be used towards research and development of new drugs.

With this harmonization initiative, drug companies can go through one set of regulatory requirements for all ASEAN countries. The company must follow the ASEAN common technical documents (ACTD) to be certified as compliant. This is, however, not as easy as it sounds. So far, only 5% of the drug industry in the Philippines is compliant with the common technical document.

This harmonization extends to all parts of the pharmaceutical sector from quality/testing, raw materials to production. The ACCSQ hopes that this synchronization of standards will lower the cost, and increase the quality and availability of medicine to countries in this regional trade bloc. At the same time, the group aims to fortify rules on importing drugs, so as to maintain the high quality of medicine that is brought into any of the Southeast Asian countries.