Adaptive regulations key to downstream pharma innovations: BPOM

Jakarta (ANTARA) - Indonesia's Food and Drug Supervisory Agency (BPOM) said adaptive biotechnology and pharmaceutical regulations are essential to speed innovation while ensuring public safety, as the global advanced therapy market is expected to more than double by 2031.

BPOM Head Taruna Ikrar said the global market for Advanced Therapy Medicinal Products (ATMPs) is projected to grow from US$41.46 billion in 2026 to US$86.76 billion by 2031.

"The data shows ATMPs are expanding rapidly worldwide. This highlights the need for strong, adaptive regulations to protect public health while ensuring safe and efficient access to innovative therapies," Ikrar said on Saturday.

He said the trend underscores the need for closer integration of neuroscience, pharmaceutical innovation and regulatory leadership to commercialize research and strengthen Indonesia's competitiveness.

"BPOM has issued guidelines for evaluating advanced therapy products under Regulation No. 8 of 2025, including Good Manufacturing Practices certification and digital monitoring of drug side effects through e-MESO," he said.

BPOM has established 186 partnerships with universities and supported innovative products from research to licensing, including the Merah Putih vaccine, Detemir insulin and stem cell therapy.

The agency said the collaboration is expected to strengthen Indonesia's innovation ecosystem and improve global competitiveness.

BPOM is also reinforcing Good Regulatory Practices, expanding regional and international cooperation, and strengthening digital oversight.

The efforts have been supported by Indonesia's recognition as a World Health Organization Listed Authority for vaccines, reflecting confidence in the country's regulatory system.

"The WLA status must be maintained through consistent performance and continuous improvement," Ikrar said.

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Translator: Mecca, Kenzu

Editor: Rahmad Nasution

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