BPOM: Adaptive Regulation Key to Downstreaming Indonesian Pharmaceutical Research

Data shows that ATMPs are experiencing dynamic and increasingly rapid growth worldwide. This development underscores the importance of strong and adaptive regulatory readiness to protect public health.

Jakarta (ANTARA) — The Food and Drug Supervisory Agency (BPOM) has stated that regulation adaptive to global developments in biotechnology and pharmaceuticals can ensure that innovations are promptly downstreamed into real products that benefit the public.

In a statement issued in Jakarta on Saturday, BPOM Head Taruna Ikrar said the global market for advanced therapy medicinal products (ATMP) is projected to grow from US$41.46 billion (around Rp697.73 trillion) in 2026 to US$86.76 billion (around Rp1,460 trillion) by 2031, with a compound annual growth rate (CAGR) of 15.91 per cent.

“These data show that ATMPs are experiencing dynamic and increasingly rapid growth across the world. This development affirms 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 guidelines for evaluating advanced therapy products through BPOM Regulation Number 8 of 2025 on Guidelines for the Assessment of Advanced Therapy Products, including Good Manufacturing Practices (GMP) certification and oversight of drug side effects through digital monitoring via e-MESO,” he said.

In addition, the agency’s role is not only to safeguard public protection but also to pave the way for investment in medicines and food.

In the context of downstreaming research, he emphasised the importance of triple helix collaboration between academia, industry and government, or the ABG Synergy.

This synergy is believed capable of strengthening the national innovation ecosystem while driving improvements in global competitiveness.

BPOM is also strengthening Good Regulatory Practices (GRP), regional and global collaboration, and the digitalisation of oversight. This is particularly so given that Indonesia has now been recognised as a WHO-Listed Authority (WLA) for vaccines, reflecting international trust in the country’s national regulatory capabilities.

“WLA status must be maintained through consistent performance and continuous improvement,” said BPOM Head Taruna Ikrar.