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Good Regulatory Practice (GRP).


1. Background

           Since 2007, the ASEAN Consultative Committee for Standards and Quality (ACCSQ) has certified the ASEAN Good Regulatory Practice (ASEAN GRP), which clearly defined in the ASEAN Policy Guideline on Standard and Conformance. The purposes of legislations of the ASEAN countries are trustworthy, fair, and consistent with international standard. Therefore, this policy would be a guideline for all agencies in the region, which work in areas related to the technical regulations and conformity assessment to promote the integration in various operations, to achieve economic integration in major areas, and will establish an ASEAN Economic Community (AEC) by the year 2015.
            FDA is a government agency, which has legal duty for public health protection, consumer protection and law enforcement responsibilities. The emphasis is on performance in the areas of governance and quality control development in accordance to international standard. Thus, it is essential that the FDA needs good knowledge and understanding of GRP.  GRP provides consistency guidance on the standard operations for each country. If any dispute occurs between countries, FDA can defend itself and claims that FDA follows standard practice on GRP. Furthermore, Thailand is a member of the World Trade Organization (WTO) with Annex 3 obligations that regulate agencies such as the FDA to operate according to ISO / IEC guide 21, which corresponds to the implementation of the GRP.

 

2. Performance


          For the 2009 budget year, the Office of International Affairs has begun preparation for the agency by developing the quality management system to enhance the implementation of technical regulations in accordance with ASEAN GRP. The project began with educating personnel of the relevant departments in the FDA and made pre-assessment analysis (Situation Analysis) to analyze the gap between the present operations and the international standard (Gap Analysis). The analysis found significant gaps that needed to be done are the Risk Impact Assessment (RIA) and the incompleteness of the FDA Regulatory Impact Statement (RIS).
          In 2011, the Planning and Research Department of the Office of International Affairs has prepared draft guidelines for regulatory impact assessment and a statement format about legal impact using appropriately as a template for FDA agencies. There were four agencies selected for case study, which are the Food Control Division, Hazardous Substances Control Division, Narcotic Control Division and the Medical Devices Control Division.

          The Office of International Affairs was in charge of the knowledge and skills development on guidelines for assessing the impact of regulation for involved authorities and workshops on "The approach to the synthesis of regulatory impact assessment and a statement format about legal impact”. This workshop was for all those involved in regulatory to recognize principles of regulatory impact assessment under the ASEAN GRP.