Through the "26th Meeting of the ASEAN Consultative Committee for Standards and Quality-Pharmaceutical Product Working Group" (ACCSQ) -PPWG) in Jakarta from November 6-10, 2018, the BPOM chief, Penny Kusumastuti Lukito, explained that this PPWG was the result of an ACCSQ meeting agreement, which was held in March 1999 in Manila, the Philippines.
PPWG was formed with the aim of meeting the regulations in ASEAN member countries, to discuss harmonization of standards in the pharmaceutical sector.
"The strategic goal was to eliminate or reduce the technical barriers to trade in pharmaceutical products in order to complement and facilitate the implementation of the ASEAN Free Trade Area (AFTA)," Lukito said.
In addition, she added, this activity also has a target to increase ASEAN`s position as a competitive production base for regional and global markets. This meeting will discuss recognition by all ASEAN member countries of the inspection report and the certificate of goods manufacturing practices (GMP) by the Listed Inspection Service.
"So there is no need for inspections by other member countries of the ASEAN local pharmaceutical industry. This is very helpful in efficient resources for regulators and the pharmaceutical industry," he said.
Lukito further said that there would be a lot of positive values that Indonesia gained in the application of ASEAN harmonization in the field of medicine. Among them, there is no double standard for drug regulation related to technical barriers to trade (TBT) in supporting the implementation of AFTA, there are similarities in ASEAN State technical guidelines for drug control, optimization of resources and funds limited to drug control (drug registration, inspection), how to produce good drugs (CPOB).
"Besides strengthening post-market supervision, including eradicating counterfeit drugs and sub-standard drugs / not fulfilling the requirements, it can improve the competitiveness of Indonesian medicinal products at home and abroad," he added.
To note, the 26th Meeting of ACCSQ-PPWG will be attended by regulators from 10 ASEAN member countries, ASEAN Secretariat and representatives from the World Health Organization (WHO), ASEAN Regional Integration Support by the EU (EU-ARISE), Generic and Biosimilars Initiative (GaBI), and others.
At this meeting, it is hoped that dialogue and interaction will occur in generating agreements that can enhance cooperation and facilitate the growth of the pharmaceutical industry, especially inter and intra trade in the ASEAN region without ignoring security guarantees, efficacy and quality of drugs circulating in the ASEAN region.
Editing by Bustanuddin