Chief Executive of Biotis Reveals Impact of BPOM's WHO Listed Authority Status on Business

Jakarta — The Chief Executive Director of Biotis Pharmaceuticals Indonesia, FX Sudirman, has stated that the WHO Listed Authority (WLA) status acquired by Indonesia’s Food and Drug Regulatory Authority (BPOM) will enhance the credibility of Indonesia’s healthcare industry. He asserted that the quality of Indonesian pharmaceutical products is on par with global standards.

“It is not just for international markets, but also for domestic consumers, because many Indonesians lack trust in local products. When the closest people to them trust our products, that is the most significant impact,” said Sudirman during the CNBC Indonesia Health Forum on Friday, 27 February 2026.

Another positive consequence of the WLA designation is that Indonesia’s healthcare industry can expand into various other countries more readily. Such expansion will be facilitated because Indonesia has gained the trust of target nations.

“With this WLA status, it is time for us to expand. Other countries now recognise us as credible. We hope for reliance. When we register in other countries at a similar level, we will not have to start from scratch,” Sudirman emphasised.

As a manufacturer of paediatric vaccines, Sudirman stated that his company is targeting new market segments in countries with high birth rates. These include Nigeria, which has an annual birth rate of 8 to 9 million, and Pakistan, which has an annual birth rate of 7 million.

“With this WLA status, we hope for an easier government-to-government approach, such as through diplomatic channels involving the Ministry of Health with Pakistan recently, because Pakistan has a high birth rate. If they can recognise our WLA status, it will be easier,” Sudirman asserted.

For context, BPOM was recently formally designated by the World Health Organization (WHO) as a WLA, a recognition that places BPOM on equal footing with leading regulatory authorities in developed nations, such as Australia’s Therapeutic Goods Administration (TGA).