Decky Yao, chairman of Indonesia’s health supplements association, the Asosiasi Pengusaha Suplemen Kesehatan Indonesia (APSKI), told NutraIngredients that the partnership could be an opportunity to reduce regulatory uncertainty for Indonesian supplement companies seeking to access Singapore and regional markets.
Exposure to Singapore’s regulatory practices could also help raise industry standards in Indonesia.
“The exposure to Singapore’s regulatory practices can elevate compliance, documentation and quality systems among Indonesian manufacturers,” he said, adding that this could lead to increased confidence in supplement safety.
Still, there may be potential challenges, such as higher compliance costs for small local players in meeting stricter or more detailed regulatory expectations.
“For both countries, the partnership encourages a more robust, transparent and internationally aligned health supplement ecosystem, supporting sustainable industry growth rather than short-term volume expansion,” Yao said.
Exchange of info and best practices
The two agencies signed a Memorandum of Understanding (MoU) on Jan. 15 in Jakarta.
The collaboration seeks to strengthen the regulation of medicines and complementary health products through the exchange of information and best practices.
For instance, there would be joint assessments of medicines and complementary health products, and strengthening of clinical trial regulations.
Other examples include participating in international and regional regulatory programs and developing joint strategic initiatives to integrate artificial intelligence (AI) into drug and healthcare product oversight, staff training programs and post-market safety surveillance of approved products.
Market access benefits
The regulators also hope to benefit businesses seeking market access in both countries.
Dr. Raymond Chua, CEO of the HSA, said that the partnership could provide more efficient regulatory pathways for companies entering both countries.
“By working together, we can better protect public health in Singapore and Indonesia while building stronger regulatory frameworks that benefit both our jurisdictions and provide avenues for more efficient regulatory pathways for businesses seeking market access in both countries.”
Dr. Taruna Ikrar, chairperson of BPOM (Badan Pengawas Obat dan Makanan), added, “This shared achievement provides a strong foundation to advance joint initiatives, strengthen institutional capacity and further align regulatory practices with internationally recognized standards, with the ultimate goal of enhancing public health protection across the region.”
Yao also highlighted how regulatory harmonization, joint assessments and information sharing could support quicker market access.
“With more aligned standards in safety, quality and post-market surveillance, there can be a reduction in duplication and a speed-up in product approvals,” he said.
However, he added that this could be a double-edged sword, as the alignment of regulations may create initial uncertainty as companies adjust to new interpretations or processes.
An easier market access in Indonesia also means increased competition from Singapore-based or international brands, he said.
WLA status as a foundation
The partnership was built on the foundation of both agencies achieving the World Health Organization (WHO) Listed Authority (WLA) status, which recognizes that their regulatory systems meet WHO’s highest international standards for oversight of medical products.
The HSA was conferred the WLA status on Oct. 26, 2023, while BPOM was recognized in December last year.
BPOM was conferred the status together with Australia’s Therapeutic Goods Administration (TGA), according to the WHO’s announcement.
A total of 41 authorities from 39 countries were recognized as WLA as of last December. Within Southeast Asia, only Singapore and Indonesia have achieved the WLA status.
The HSA said that the WLA status has provided a strong foundation for regulatory cooperation with BPOM.
In addition to the MoU signing, the two agencies held a bilateral meeting discussing topics such as strengthening the regional collaboration framework in the ASEAN (Association of Southeast Asian Nations) region and developing regulatory reliance and joint assessment mechanisms.
They also shared insights on regulatory developments using technological and innovative approaches, such as regulations for cell- and gene-based therapies, radiopharmaceuticals, digital therapies and the use of AI in health product oversight.
Industry’s hopes for the partnership
Speaking on behalf of APSKI, Yao hopes that the partnership will achieve five key goals.
At the top of the list is to establish clearer and faster regulatory pathways, particularly for well-established, compliant health supplement products.
Second, by aligning with globally recognized regulatory benchmarks, the association aims to strengthen Indonesia’s position as a regional manufacturing hub.
Third, the partnership is expected to facilitate knowledge transfer and capacity through training programs, joint initiatives and the sharing of regulatory science.
Fourth, it can be steered to support innovation in health supplements, including functional ingredients, evidence-based formulations and emerging technologies.
Last but not least, the association seeks to promote consumer protection while simultaneously supporting industry growth.
Lead up to the collaboration
The two agencies had discussed opportunities for joint assessments and shared experiences on the process towards WLA back in July 2024, according to BPOM.
That same year, HSA participants received training at BPOM’s National Center for Drug and Food Testing Development (PPPOMN) Laboratory through a workshop on Lot Release and Laboratory Testing for Diphtheria, Tetanus and Pertussis, Influenza and Meningococcus Vaccines.
Last April, leaders from the two agencies held a bilateral meeting in Tokyo, which sparked the signing of an MoU to strengthen the collaboration agreement in the regulatory field.
“The collaboration between BPOM and HSA Singapore is an important and highly strategic step in strengthening national regulatory capacity and increasing trust in the drug and health product monitoring system,” said Dr. Ikrar of BPOM.
He added that the collaboration is also seen as an effort to strengthen the regulatory system in the wider ASEAN region.
“BPOM views this collaboration as not only important for Indonesia and Singapore, but also as part of efforts to strengthen the regulatory system in the ASEAN region, particularly in addressing the challenges of health technology innovation and the safe and responsible development of advanced therapeutic products,” he said.
