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The Indonesian Food and Drug Administration (BPOM), through the International Forum of Pharmaceutical Inspection Bodies (IFPI), emphasized the direction of strengthening regional and global drug regulation.
2026-03-19
Abu Dhabi, UAE – Taruna Ikrar, Director General of the Indonesian Pharmaceutical and Food Regulatory Authority (BPOM), attended the 2nd International Forum of Pharmaceutical Inspectors (IFPI) to be held in Abu Dhabi on November 24–25, 2025. This international forum serves as a platform for professional dialogue and experience exchange among pharmaceutical regulatory agencies, drug inspection authorities, and pharmaceutical industry experts from various countries. The BPOM Director General's attendance represents not only Indonesia and BPOM, but also the pharmaceutical and food regulatory agencies of the ASEAN region. Taruna delivered a speech entitled “Harmonization of ASEAN Pharmaceutical Regulations” at the plenary session. On Monday, November 24, Taruna was one of the panelists in the first discussion session, discussing the theme “Regulatory Harmonization of Pharmaceutical Manufacturing: Trends in Regional Unions.” Also speaking were Siarhei Seradziuk, Deputy Director of the Belarusian State Institution Gosfarmnadzor, and Washington Dengu, Good Manufacturing Practice (GMP) Inspection Coordinator of the African Medicines Regulatory Convergence Project (AMRH). In his opening remarks, Taruna introduced the current regulatory situation in Indonesia. Indonesian regulations for pharmaceuticals cover the entire lifecycle, including product development, clinical evaluation, production, distribution, and post-market surveillance. “Multiple dynamics in the pharmaceutical industry, such as accelerated product innovation, the expanding global supply chains, and faster and easier cross-border trade, have led to an increasing risk of illicit/counterfeit/inferior drugs circulating in the market and other threats to public health,” Taruna explained. He added, “Therefore, BPOM remains adaptable, vigilant, and innovative, implementing a comprehensive regulatory system that covers pre-market control, post-market surveillance, enforcement, and public empowerment.” Several strategic agendas for Indonesian drug regulation include: science-based regulation, risk-driven inspections, accelerating access to innovative and essential medicines, strengthening regional supply chains, and achieving self-sufficiency in pharmaceutical raw materials. To advance these strategic agendas and simultaneously strengthen national pharmaceutical policy, Taruna emphasized the importance of regional and global collaboration. Indonesia joined the Pharmaceutical Inspection Cooperation Scheme (PIC/S) in 2012, as part of its global collaboration efforts. PIC/S is an informal collaboration between drug and food regulatory agencies aimed at harmonizing global inspection procedures by establishing common standards in the field of Good Manufacturing Practices (GMP). Joining PIC/S provides training opportunities for GMP inspectors and fosters cooperation and networking among competent authorities, regional and international organizations, thereby enhancing mutual trust. Furthermore, Taruna reviewed the progress made in pharmaceutical regulatory convergence since 1992 within the framework of the ASEAN Advisory Committee on Standards and Quality (ACCSQ). ACCSQ established the Pharmaceutical Products Working Group (PPWG) in 1999, which aims to promote pharmaceutical regulatory convergence among ASEAN member states, including refining and advancing the ASEAN Free Trade Area (AFTA) objectives in the pharmaceutical field, while ensuring the protection of public health through maintaining standards of safety, efficacy, and quality. “With ACCSQ and the PPWG, we have jointly developed joint documents, common technical requirements, common guidelines, and now mutual recognition agreements. This cooperation certainly requires a high degree of regulatory trust, so progress has been gradual but strategic. Ultimately, these efforts aim to create a more integrated, efficient, and people-centered regulatory environment for the whole of ASEAN,” Taruna added.
Following his speech, the BPOM Director General gave interviews to several media outlets present. When asked by a reporter for his assessment of IFPI activities, Taruna expressed positive affirmation of the forum as a platform for regional and global collaboration. “Cooperation is better than competition. If we cooperate, everyone will benefit,” Taruna concluded. (HM-Julio/HM-Herma)
The presence of the BPOM Director General represented not only Indonesia and BPOM, but also the pharmaceutical and food regulatory agencies of the ASEAN region. Taruna delivered a speech at the plenary session entitled "Harmonization of ASEAN Pharmaceutical Regulations." On Monday, November 24th, Taruna was one of the panelists in the first discussion session, focusing on the theme "Regulatory Harmonization of Pharmaceutical Manufacturing: Trends in Regional Unions." Also speaking were Siarhei Seradziuk, Deputy Director of the Belarusian State Agency Gosfarmnadzor, and Washington Dengu, Good Manufacturing Practice (GMP) Inspection Coordinator of the African Project for Convergence of Pharmaceutical Regulatory Services (AMRH). In his opening remarks, Taruna introduced the current regulatory situation in Indonesia. Indonesian pharmaceutical regulation covers the entire lifecycle, including product development, clinical evaluation, production, distribution, and post-market surveillance. “Multiple dynamics in the pharmaceutical industry, such as accelerated product innovation, the expanding global supply chains, and faster and more convenient cross-border trade, have led to an increase in the risks of illicit/counterfeit/inferior drug distribution and other threats to public health,” Taruna explained. He added, “Therefore, BPOM remains adaptable, vigilant, and innovative, implementing a comprehensive regulatory system covering pre-market controls, post-market surveillance, enforcement, and public empowerment.” Several strategic agendas for Indonesian drug regulation include: science-based regulation, risk-oriented inspections, accelerating access to innovative and essential medicines, strengthening regional supply chains, and achieving self-sufficiency in pharmaceutical raw materials. To advance these strategic agendas and simultaneously strengthen national pharmaceutical policy, Taruna emphasized the importance of regional and global collaboration. Indonesia joined the Pharmaceutical Inspection Cooperation Scheme (PIC/S) in 2012, which is one of its forms of global collaboration.
The PIC/S is an informal collaboration between pharmaceutical and food regulatory agencies aimed at harmonizing global inspection procedures by developing common standards in the field of Good Manufacturing Practices (GMP). Joining the PIC/S provides training opportunities for GMP inspectors and fosters cooperation and networking among competent authorities, regional and international organizations, thereby enhancing mutual trust. Furthermore, Taruna reviewed the progress made in pharmaceutical regulatory convergence since 1992 within the framework of the ASEAN Advisory Committee on Standards and Quality (ACCSQ). ACCSQ established the Pharmaceutical Products Working Group (PPWG) in 1999, which aims to promote pharmaceutical regulatory convergence among ASEAN member states, including refining and advancing the ASEAN Free Trade Area (AFTA) objectives in the pharmaceutical sector, while ensuring the protection of public health through maintaining standards of safety, efficacy, and quality. “With ACCSQ and the PPWG, we have jointly developed joint documents, common technical requirements, common guidelines, and now mutual recognition agreements. This cooperation certainly requires a high degree of regulatory trust, so progress has been gradual but strategic. Ultimately, these efforts aim to create a more integrated, efficient, and people-centered regulatory environment for the whole of ASEAN,” Taruna added. Following his speech, the BPOM Director General gave interviews to several media outlets present. When asked by a reporter for his assessment of IFPI activities, Taruna expressed positive affirmation of the forum as a platform for regional and global collaboration. “Cooperation is better than competition. If we cooperate, everyone will benefit,” Taruna concluded. (HM-Julio/HM-Herma)