BPOM: Adaptive Regulation Key to Downstreaming Indonesian Pharmaceutical Research

The Food and Drug Monitoring Agency (BPOM) has stated that regulations adaptive to global developments in biotechnology and pharmaceuticals can ensure that innovations are swiftly downstreamed into tangible products beneficial to the public. In a statement in Jakarta on Saturday, BPOM Head Taruna Ikrar noted that the global manufacturing market for advanced therapy medicinal products (ATMP) is projected to increase from USD 41.46 billion (approximately IDR 697.73 trillion) in 2026 to USD 86.76 billion (approximately IDR 1,460 trillion) by 2031, with a compound annual growth rate (CAGR) of 15.91 percent. “This data shows that ATMP is experiencing dynamic and accelerating growth worldwide. This development underscores the importance of strong and adaptive regulatory readiness to protect public health, while ensuring safe, effective, and efficient access to innovative therapies,” said Taruna Ikrar. “BPOM has established evaluation guidelines for advanced therapy products through BPOM Regulation Number 8 of 2025 concerning Guidelines for the Assessment of Advanced Therapy Products, including Good Manufacturing Practices (GMP) certification and digital monitoring of drug side effects via e-MESO,” he said. Furthermore, the agency not only plays a role in safeguarding public protection but also paves the way for investment in drugs and food. In the context of research downstreaming, he emphasised the importance of triple-helix collaboration between academia, industry, and government, known as ABG Synergy. This synergy is believed to be capable of strengthening the national innovation ecosystem while boosting global competitiveness. BPOM is also strengthening Good Regulatory Practices (GRP), regional and global collaboration, and digitalisation of supervision, especially following Indonesia’s recognition as a WHO-Listed Authority (WLA) for vaccines, reflecting international trust in national regulatory capabilities. “WLA status must be maintained through consistent performance and continuous improvement,” said BPOM Head Taruna Ikrar.