ASEAN Consultative Committee for Standards and Quality (ACCSQ) was established by ASEAN Economic Minister in 1992 to facilitate ASEAN Free Trade Area (AFTA) goal achieving. In the 4th Seniors Economic Official Meeting (SEOM) organized in Medan in 1997, it was agreed the revision of ACCSQ Term of Reference which included giving mandate to ACCSQ to enhance the role of regulating bodies in eliminating the technical border of trading. In the 12th ACCSQ held in Bangkok, Thailand on August 1998, it was agreed Malaysia’s proposal for harmonized ASEAN technical stipulation in the field of pharmacy, which constantly considering the aspects of drug’s safety, quality, and efficacy. For that, it was established ACCSQ-PPWG that was given the mandate to review qualification and technical stipulation in the field of ASEAN and global pharmacy, including harmonized procedures and system that is valid in other countries (eg. ICH), and to develop harmonized technical stipulation and to develop ASEAN common technical documents headed to ASEAN Mutual Recognition Arrangement (MRA) in the field of pharmacy.
ACCSQ PPWG meetings have been conducted 11 times and have resulted some products where in the developing process has been pointed one ASEAN country as the lead country, as follows:
|ASEAN HARMONIZATION PRODUCTS IN THE FIELD OF PHARMACY ||LEAD COUNTRY |
|ASEAN Common Technical Dossier (ACTD) Administrative Data and Product Information ||Malaysia |
|ASEAN Common Technical Dossier (ACTD) Quality ||Indonesia |
|ASEAN Common Technical Dossier (ACTD) Efficacy ||Thailand |
|ASEAN Common Technical Dossier (ACTD) Safety ||Philippines |
|ASEAN Guideline on Stability Study of Drug Product ||Indonesia |
|ASEAN Guideline for the Product of Bioavailability and Bioequivalences Studies ||Malaysia |
|ASEAN Guidelines for Validation of Analytical Procedures ||Thailand |
|ASEAN Guidelines on Submission of Manufacturing Process Validation Data for Drug Registration ||Singapore |
In several ACCSQ PPWG meetings, it was agreed that ACTD implementation target was 1 January 2009, but each ASEAN country may set target earlier depends on the readiness. For that, targets of each ASEAN country are as follows:
The meetings have also agreed that the transition periode was untill 1 January 2009 and during that, country member may use Common Technical Dossier (CTD) format of each country or suitable format based on ACTD. However, starting on 31 December 2008 all registration document in ASEAN should appropriate to ACTD.
- Singapore and Malaysia : 31 December 2005
- Thailand: 31 December 2006
- Indonesia and Vietnam: 31 December 2007
- Brunei, Cambodia, Lao PDR, and Philippines: 31 Desember 2008
In the 11th ACCSQ PPWG meeting, that was held on March 2006 in Hanoi, it was stated that Indonesia would be the host of the 12th meeting. The 12th ACCSQ PPWG meeting would be conducted in Jakarta on 1 – 3 November 2006, which would be attended by ASEAN country delegations, Resource persons from World Health Organization (WHO) and ASEAN Secretariate and also observers from pharmaceutical industries delegations of ASEAN. Prior to the 12th meeting, it has been conducted several meetings related to ASEAN pharmacy product implementation and Quality technical stepulation ASEAN pharmacy product.
The expected output of the 12th ACCSQ PPWG meeting was stabilization of harmonized product implementation, through discussions among task force members and dialogues with pharmaceutical industries.
| || Jakarta, 1 November 2006 |
Head of National Agency for Drug and Food Control
dr. Husniah Rubiana Thamrin Akib, MS, MKes, SpFK