Indonesia Boosts ATMP Research with Clinical Trial Expansion and Lab Upgrades
核心洞察
Indonesia's Health Ministry is facilitating Advanced Therapy Medicinal Products (ATMPs) research by establishing clinical research units in hospitals.
The initiative supports the global shift towards biological medicines, now comprising 65% of the market, to enhance national pharmaceutical resilience.
The National Food and Drug Authority (BPOM) (搜索) plans to upgrade 80 labs to international standards, improving accuracy and global recognition.
Indonesia is intensifying its focus on Advanced Therapy Medicinal Products (ATMPs) by expanding clinical trial capabilities and upgrading laboratory infrastructure. The Health Ministry is coordinating the establishment of clinical research units within hospitals to bolster national pharmaceutical resilience and support the development of innovative biological medicines.
Supporting Biological Medicine Research
Lucia Rizka Andalusia, the Health Ministry's Director General for Pharmaceuticals and Medical Devices, emphasized the growing global trend toward biological medicines, which currently account for 65% of the pharmaceutical market. She highlighted the critical need to support research and development in this area to ensure national pharmaceutical independence. "These health product studies align with our health system transformation," she stated, underscoring the strategic importance of ATMP research.
ATMPs, which include cell therapies and tissue engineering, represent a cutting-edge approach to medical treatment. The ministry's comprehensive strategy encompasses the preparation, research, production, and application of these therapies. Andalusia noted that clinical trials are the most challenging aspect of health technology research, prompting the ministry to facilitate the process through dedicated clinical research units. The research will be evidence-based, informing the National Food and Drug Authority (BPOM) (搜索) in its approval process based on product safety and efficacy.
BPOM's Laboratory Upgrade Initiative
BPOM Head Taruna Ikrar announced plans to upgrade 80 laboratories across Indonesia to meet international standards. This initiative aims to enhance the accuracy and sustainability of lab services through digitalization. Achieving international recognition from the World Health Organization (WHO) is a key goal, which would significantly improve the quality of lab services and BPOM's overall performance. "This will positively impact the quality of lab services and BPOM’s performance," Ikrar stated. "Ultimately, it will benefit the economy and public welfare as a whole."
Indonesia already has pharmaceutical companies producing essential biological products like insulin for diabetes (搜索) and erythropoietin for kidney (搜索) patients. The Health Ministry is committed to further improving the industry's capacity and quality to produce a wider range of biological products. The upgraded laboratories are expected to accelerate the research and development of ATMPs, contributing to a stronger and more resilient national pharmaceutical sector.