ASEAN Regional Integration Support from the EU

Component 2: Standards and Conformity Assessment in Healthcare and Food Products

The main objective of this component is to support the effective implementation of ASEAN’s 2016-2025 Strategic Plan for Standards and Conformance. Component 2 extends support to the harmonization of standards and to the development of globally recognised accreditation systems that will ensure credibility of conformity assessment across all industry sectors in ASEAN. In addition to the horizontal actions on standards and conformity assessment, Component 2 has specifically focussed activities for the agro-food and the pharmaceutical sectors. The activities planned under this component are designed to support the ASEAN Strategic Plan’s thrusts that provide for the strengthening of the quality infrastructure in the region, removal of technical barriers to trade and facilitation of market integration.

Support towards standards and conformity assessment is extended via activities that support ASEAN’s Working Groups for Standards and Conformity Assessment. The activities re aimed at to enhancing the harmonisation of standards and the development of harmonised and mutually recognised conformity assessment that is underpinned by a credible accreditation. In addition to this,? ARISE Plus has included complementary activities that will support the? transposition of regional commitments into national legislation and enhance co-ordination across ASEAN’s numerous sectoral working groups.

For the sectoral focus “Supporting Market Integration and Enhancing Food Safety in Agro-base Sector”, the activities are targeted at contributing towards the development and implementation of a regulatory framework for food safety for the whole of ASEAN.? This includes implementation of the recently agreed Mutual Recognition Agreement on Inspection and Certification Systems of Food Hygiene and Prepared Food stuffs. In addition to this ARISE Plus supports the newly established ASEAN Risk Assessment Centre (ARAC) for food safety. ARAC is expected to assume a key role in supporting ASEAN food safety regulators to implement harmonised food safety risk management strategies. . ARISE Plus also contributes towards the establishment of Rapid Alert Systems for Food and Feed (RASFF) in Member States and integrating them regionally in the ASEAN Rapid Alert Systems for Food and Feed (ARASFF).

The sectoral “Support for the Pharmaceutical Sector” is targeted at the strengthening of the pharmaceutical regulatory framework with additional support on combatting falsified medicines and enhancing pharmaceutical standardisation in ASEAN.? These activities will help the adoption of a harmonised approach for pharmaceutical regulation that enhances regulatory systems removes technical barriers for intra-ASEAN trade in turn facilitating the production of pharmaceuticals and improving access to medicines in ASEAN.


Implementation Strategy


To support greater economic integration in ASEAN through the full implementation of the ASEAN Trade in Goods Agreement (ATIGA) and of the ASEAN Economic Community Blue Print 2025 (AECB)

Sub-Component 2.1Supporting the Development Quality Infrastructure and related policies in ASEAN
Technical barriers to trade for intra-ASEAN trade are reduced through the adoption of policies, mutual recognition arrangements, harmonisation of regulatory regimes and the development of the quality infrastructure and supporting mechanisms for market integration
Sub-Component 2.2Supporting the Harmonisation of Standards and Compliance to International Standards
Market integration advanced with the increased number of standards harmonised in ASEAN that are aligned with international standards which are adopted by regulatory authorities and referenced by ASEAN businesses and industry
Sub-Component 2.3Supporting the Market Integration and Enhancing Food Safety in Agro-based Sector
Reduced barriers for trade in food products and essential food safety levels ensured across AMS through the establishment of an integrated regulatory framework for food safety based on harmonised standards and measures
Sub-Component 2.4Support to the Pharmaceutical sector
The adoption of a common approach and agenda for pharmaceutical regulation that enhances the regulatory systems for pharmaceuticals in turn facilitating the production of pharmaceuticals and improving access to medicines in ASEAN
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