Fast-tracking registration of key antimalarial products in Myanmar

Australia’s national medicines regulatory organization – the Therapeutic Goods Administration (TGA) – is an active partner in the Regional Regulatory Partnership for Malaria Elimination (RRP). The TGA recently completed three days of working sessions in Myanmar with the country’s National Medicine Regulatory Authority and the National Malaria Programme.

The RRP helps countries strengthen national capacities to effectively register and monitor the quality of new/priority medicines and diagnostic tests, including antimalarial products. Key efforts already underway in Myanmar include setting up an online registration system, with support from the Asian Development Bank (ADB).

Representatives from the TGA, the Australian Department of Foreign Affair’s (DFAT) and APLMA met with the Department of Food and Drug Administration (DFDA) and the National Malaria Programme to agree on areas for technical support and capacity building by TGA. Discussions highlighted the need for technical assistance with development of guidelines for fast-tracking registration of critical health technologies. This was prioritized during consultations with other RRP partners, including the World Health Organization (WHO), and is likely to be part of TGA support to Myanmar over the next five years. A similar activity was recently conducted in Lao PDR, where expediting registration of key antimalarial products is also key to achieving malaria elimination by 2030. Fast-tracking of key products will also help tackle the emerging threat of drug-resistant malaria in the Greater Mekong Sub-region, and contribute to broader regional health security.

RRP partners also had the opportunity to meet with Dr Thandar Lwin, Deputy Director General of the Communicable Disease Department, and Dr Aung Thi from the National Malaria Control Programme to outline the fast-tracking initiative. Both welcomed efforts as part of a broader coordination with international partners working in Myanmar, including the RRP. Dr Aung Thi acknowledged the positive role of APLMA and the RRP in fostering regional collaboration to improve access to priority health products in Myanmar.

We are thankful to the International Relations Division of the Ministry of Health and Sports for their support in arranging this visit. We would also like to acknowledge the DFDA and the National Malaria Control Programme for their continuous commitment to malaria elimination and the work of the RRP.

TGA’s work in Myanmar is funded by the DFAT Health Security Initiative for the Indo-Pacific Region.