- BPOM-TGA boost regional health regulation
- Focus on WHO Maturity Level 3 support
- Cooperation spans advanced therapies, trials
Indonesia’s National Agency of Drug and Food Control (BPOM) and Australia’s Therapeutic Goods Administration (TGA) are expanding collaboration to reinforce health regulation standards across the Western Pacific region. The initiative aims to support more countries in achieving the World Health Organization’s Maturity Level 3 benchmark, a key indicator of a stable and well-functioning regulatory system.
The strengthened partnership follows both agencies attaining WHO-Listed Authority (WLA) status, positioning them as recognised global regulators. BPOM Head Taruna Ikrar said in Jakarta recently that the cooperation is strategically designed to enhance capacity-building programmes, training exchanges and regional harmonisation platforms.
“We want to ensure this collaboration delivers tangible benefits for public health protection, drives innovation, and strengthens regional stability in the WHO Western Pacific region,” he noted.
The discussions build on Ikrar’s official visit to Canberra in August 2025, during which the two agencies launched the inaugural Indo-Pacific Regulatory Strengthening Program (RSP) internship. The programme has facilitated knowledge transfer from TGA and supported Indonesia’s transition toward a more adaptive, efficient and risk-based regulatory framework.
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Talks also covered regulatory approaches for advanced therapies, including gene therapies and Advanced Therapy Medicinal Products (ATMPs), as well as clinical trial oversight, e-cigarette and novel nicotine product regulation, and joint assessment mechanisms to accelerate patient access to innovative medicines.
BPOM proposed strengthening bilateral reliance practices in accordance with WHO’s Good Reliance Principles, highlighting transparency, legal clarity, consistency and respect for national sovereignty.
TGA Deputy Secretary Anthony Lawler welcomed the proposal, stating, “TGA views BPOM as a regulator that is increasingly mature and credible. With both countries now holding WLA status, there is greater scope for structured reliance pathways and deeper technical collaboration.”
Indonesia also underscored its potential as a regional hub for multinational clinical trials, supported by an integrated regulatory framework and extensive clinical research networks. The collaboration is expected to further advance research partnerships across the Asia-Pacific.