THE SPECIAL MEETING OF THE HEADS OF DELEGATION OF THE ASEAN PHARMACEUTICAL PRODUCT WORKING GROUP (PPWG)
29 – 30 November 2017
Bandar Seri Begawan
The Ministry of Health Brunei Darussalam, this year is hosting the Special Meeting of the Heads of Delegation of the ASEAN Pharmaceutical Product Working Group (PPWG). The meeting is held for two days from November 29th until November 30th 2017, at Dewan Al-'Afiah, Ministry of Health, Bandar Seri Begawan.
The Special Meeting of the Heads of Delegation of the ASEAN PPWG in Brunei Darussalam discussed several matters including; the review of the term of reference of PPWG; progress of implementation of the Mutual Recognition Arrangement (MRA) on Bioequivalence Study Report and MRA on Good Manufacturing Practice (GMP) Inspection of Manufacturers for Medicinal Products; as well as the ASEAN Post Market Alert System and Cooperation with International / Regional Organization.
A total of 21 delegates from the ASEAN Member States and 3 local observers from government agencies attended the Special Meeting of the Heads of Delegation of the ASEAN PPWG.
The Special Meeting convenes for the second time this year and is held before the next ASEAN Consultative Committee on Standards and Quality (ACCSQ) meeting. The Pharmaceutical Product Working Group (PPWG) was established following the recommendation from the 13th ASEAN Consultative Committee on Standards and Quality (ACCSQ) Meeting (held from 18-19 March 1999 in Manila, Philippines) to the SEOM 1/30 (held from 28-30 January 2000 in Jakarta, Indonesia) to establish a working group to facilitate economic integration initiatives for pharmaceutical products without compromising their safety, efficacy and quality.
Amongst the major achievements of PPWG are as follows:
- In 2008, PPWG concluded harmonized requirements of ASEAN Common Technical Dossier (ACTD) and ASEAN Common Technical Requirements (ACTR).
- In 2009, the PPWG concluded the ASEAN Sectoral MRA for Good Manufacturing Practice (GMP) Inspection of Manufacturers of Medicinal Products in 2008, which was signed by the ASEAN Economic Ministers (AEM) on 10 April 2009 during the 14th ASEAN Summit.
- In 2016, PPWG concluded the ASEAN Sectoral MRA on Bio-equivalence (BE) Study report for Generic Medicinal Products, which was signed by the AEM in November 2017.
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Date : 30 November 2017 / 11 Rabiulawal 1439
Reference : KK/PR/3