BPOM: Adaptive Regulations Boost Innovation in Precision Medicine and ATMP

The Indonesian Food and Drug Authority (BPOM) has stated that adaptive regulation is a proactive step for Indonesia to welcome the development of precision medicine and Advanced Therapy Medicinal Products (ATMP), ensuring they can flourish while maintaining safety, efficacy, and quality.

Speaking in Jakarta on Monday, the Head of BPOM, Taruna Ikrar, noted that accelerating regulation is a vital component in building a health innovation ecosystem capable of addressing both scientific advancements and public needs. However, he emphasised that such acceleration must proceed with the principle of precaution and robust supervision to ensure that developed products meet established requirements.

“BPOM is actively supporting domestic innovation through special regulatory pathways at every stage of product development, referring to BPOM Regulation Number 8 of 2025 regarding the Assessment of Advanced Therapy Products and BPOM Regulation Number 24 of 2025 regarding the Approval of New Drug Development,” said Taruna Ikrar.

Meanwhile, the Minister of Health, Budi Gunadi Sadikin, expressed appreciation for the efforts to support biotechnology-based health transformation. He emphasised the importance of collaboration with industry and the utilisation of science, including genomic data through the Biomedical and Genome Science Initiative (BGSi), to strengthen national health resilience and prepare Indonesia for next-generation health technology developments.

Furthermore, the President Director of PT Kalbe Farma Tbk, Irawati Setiady, stated that the company will continue to be part of an ecosystem that brings together science, innovation, and collaboration, ensuring that advancements in health technology provide tangible benefits to patients and the Indonesian people.

Through BPOM’s presence in this scientific forum, cross-sector collaboration is expected to strengthen in overseeing the development of next-generation health technologies. BPOM remains committed to providing adaptive and responsive regulations to scientific progress, while ensuring every innovation developed adheres to the principles of safety, efficacy, and quality to provide optimal benefits for the Indonesian public.