Dili: When a child is vaccinated or a patient swallows a tablet, how can anyone be sure the product is safe, effective and of good quality?
This depends not only on doctors, nurses and pharmacists. It rests on laws and regulatory systems that check medical products before they reach patients and keep checking long afterwards.
Strengthening these safeguards was the focus of a three-day national workshop in Dili from 21 to 23 October, led by the Ministry of Health with technical support from the World Health Organization Timor-Leste, the WHO Regional Office for South-East Asia and Australia's Therapeutic Goods Administration (TGA).
/countries/timor-leste/national-worshop-for-legal-framework-for-medical-product.jpg?sfvrsn=f6c5bddd_2 "National Worshop For Legal Framework for medical Product")
The discussions on the table were: Who approves medicines before they enter the market? How are pharmacies and health facilities licensed and inspected? What happens when a product turns out to be unsafe or of poor quality? And do public and private health facilities answer to the same standards?
Dr Raimundo dos Santos, Director General of Health Services, highlighted that regulators are an essential part of the health workforce, although patients rarely meet them. “Good regulatory practices are fundamental for public health,” he said.
/countries/timor-leste/dr-raimundo-dos-santos--director-general-of-health-services.jpg?sfvrsn=f775cff4_2 "Dr Raimundo dos Santos, Director General of Health Services")
Dr Raimundo dos Santos, Director-General of Health Services, opens the workshop. @WHO Timor-Leste
Nearly a decade of WHO support
WHO has been working with the Ministry of Health and these institutions for nearly a decade to strengthen Timor-Leste's capacity to regulate medicines and health products.
2016 assessment supported by WHO and GAVI, the Vaccine Alliance, placed the country’s vaccine regulatory system at the earliest stage of development. A follow-up in 2023 noted some improvements but also identified areas for improvement, especially regarding legal provisions. Both assessments shaped WHO’s continuing technical support.
In 2025, a joint WHO–TGA mission noted that Decree-Law No. 2/2025, which replaced the earlier legislation, did not cover several essential regulatory functions, including aspects of medicine registration, licensing, inspections and enforcement. WHO and TGA recommended completing and harmonising the remaining legal provisions so that the system could work as a whole.
Timor-Leste has since taken several steps forward. The National Medicines and Health Products Policy 2025 provides a foundation for stronger regulation, a decree-law on medical prescriptions has been finalised, and a draft law on medicine registration has been developed.
The October workshop built on that momentum. It brought the regulatory institutions and legal experts into one room to review existing and proposed laws, clarify who is responsible for what, and pin down the gaps that remain.
Dr Benjamin Gilbert of the TGA and Dr Adrien Inoubli, Unit Head at the WHO Regional Office for South-East Asia, provided technical expertise working alongside Ministry of Health officials and the directors of the four institutions.
/countries/timor-leste/dr-adrien-inoubli-delivers-a-presentation-at-the-national-workshop-in-dili.jpg?sfvrsn=29712a6d_2 "Dr Adrien Inoubli delivers a presentation at the National Workshop in Dili")
Dr Adrien Inoubli, Unit Head at the WHO Regional Office for South-East Asia, presents the framework for medical product regulation in Timor-Leste. @WHO Timor-Leste
What needs to happen next?
Dr Arvind Mathur, WHO Representative to Timor-Leste, said the first priority is clear and consistent rules for the approval, inspection and monitoring of health products across the country. “Important steps also include the opportunity to review Decree-Law No. 2/2025 in 2027 to address gaps in inspection and licensing, including the current exemption for public sector facilities,” he said.
The workshop also underlined that a new decree-law is needed to cover marketing authorisation, vigilance, market surveillance and control, Good Manufacturing Practices and clinical trials. Dedicated legal provisions for laboratory testing are also required. Addressing these gaps will ensure Timor-Leste is aligned with international standards, including ASEAN requirements.
/countries/timor-leste/national-workshop-for-legal-framework-for-medical-product-1.jpg?sfvrsn=7f7d5843_2 "National Workshop For Legal Framework for medical Product 1") | /countries/timor-leste/national-workshop-for-legal-framework-for-medical-product-2.jpg?sfvrsn=f120a4fd_2 "National Workshop For Legal Framework for medical Product 2") |
WHO's support extends beyond reviewing legislation. Through its regulatory systems strengthening programme, WHO helps countries assess their systems against international standards, develop improvement plans and build the technical capacity needed to implement them.