Accepted Abstracts: Pharmaceut Reg Affairs
Since global trade has become more competitive, the region of ASEAN has tried hard to build a strong economic alliance to enhance the trade facilitation by the elimination of both tariff and non-tariff barrier. To eliminate non-tariff barriers, ASEAN member countries have recognized the need to put in place harmonized technical regulations as one community-one standard. Cosmetics sector is the first healthcare product sector which was claimed to be fully harmonized and implemented in the region. The Agreement on the ASEAN Harmonized Regulatory Scheme (AHCRS) was signed on the 2nd September 2003. The AHCRS was first implemented in all ASEAN member countries on 1st January 2008 with the 3 years grace period commitment. All ASEAN members should have undertaken appropriate measures to adopt and implement the technical areas of the ASEAN Cosmetic Directive (ACD). The levels of ACD implementation could be different among member countries which depend on national regulation background. The level of ACD implementation also depends on the country context; culture, language and way of life. These different aspects may impact the level of control on cosmetics products. The harmonization has happened, even though it is not complete as expected. It has happened in the ASEAN way. To update the implementation and the compliance of the member state will help the country to know its status and be able to set up a good plan or strategies for moving forward to the success of ASEAN economic community (AEC) in 2015. It could also help to encourage regulator and industry sectors of each member state to focus on existing problems. More effort should be spent on how to achieve successful harmonization or revising ACD. This is to better prepare the member states to be ready for a single market and single community in 2015.
Neeranard Jinachai has completed her Master Degree in Pharmaceutical Science from Chulalongkorn University and is now being a PhD candidate of the Graduate Program in Social and Administrative Pharmacy (International Program) Faculty of Pharmaceutical Sciences, Chulalongkorn University, Bangkok, Thailand. She has been in the area of regulatory affairs for healthcare products; pharmaceutical product, cosmetic product, medical device, and food supplements for more than 15 years. She is currently the Director of Regulatory Affairs of L?Oreal (Thailand) Ltd.