Officials from ASEAN Member States have launched a new initiative that involves active cross pillar collaboration in ensuring the quality, safety and efficacy of medicines that are placed in the ASEAN market. This collaboration has been undertaken by the ASEAN Pharmaceutical Product Working Group (PPWG) under the ASEAN Economic Ministers and Health Cluster 3 Strengthening health system and access to Care (AHC 3), a Group under the ASEAN Health Ministers.
PPWG and AHC 3 have jointly recognised that in order to provide a structure and instruments that have been developed by both groups and to ensure both the safety and trade aspects are covered across the complete life cycle of pharmaceuticals, it is important to have a common regulatory policy and an agreed framework for regulation. The Workshop ASEAN Pharmaceutical Regulatory Policy and the ASEAN Pharmaceutical Regulatory Framework (APRP and APRF) was held on the 21 – 22 April 2021 with the support of ARISE Plus to discuss the formulation of this policy and regulatory framework for ASEAN. The workshop is a first significant milestone in the ambitious longer term target to establish and adopt a common policy that when adopted can be deployed through an ASEAN framework that will provide the structure , legal instruments and implementation arrangements.
The discussions at workshop were centred on the first draft of the ASEAN Pharmaceutical Regulatory Policy and the ASEAN Pharmaceutical Regulatory Framework (APRP and APRF). This draft had been prepared by ARISE Plus in consultation with ASEAN Secretariat and PPWG Members. Extensive discussion on the APRP during the workshop indicated a significant consensus of the principles for pharmaceutical regulation. In the conclusion of the event, the participants noted that more discussion was needed and recommended subsequent workshop be planned to be held within the next 2-3 months to continue discussions on the APRP and the APRF.
The workshop is a specially significant as this marks first occasion for representatives of the AHC 3 from the Health sector to participate in the deliberations jointly with PPWG which represents the Economic Sector. The joint workshop that was made possible with the support of the ASEAN Consultative Committee for Standards & Quality (ACCSQ) the support of the Senior Officials Of Health Ministries (SOM Health), will ensure that a coherent policy and framework is developed to realise the vision for a free flow of safe, efficient and quality pharmaceuticals in the region to support the strengthening of healthcare systems.