Lao PDR: Continuing improvement of antimalarial regulatory approval

Comprehensive efforts to enhance market authorization for priority medicines, including antimalarial medicines, are continuing in the Lao People’s Democratic Republic (PDR). This week, a joint team from the Australian Therapeutic Goods Administration (TGA) and the Asia Pacific Leaders Malaria Alliance (APLMA) worked closely with staff from the Lao PDR Food and Drug Department (FDD) to review registration pathways and develop recommendations for strengthening and enhancing current systems for registration of priority medicines.

This ongoing collaboration builds on a first visit of the TGA with counterparts in Lao PDR in December 2017. The TGA is actively scoping and gathering information alongside technical FDD staff on how the review of drug applications takes place. By doing so, it is hoped that specific bottlenecks can be addressed and opportunities for improving the timeliness of registrations can be explored. The initial aim is to increase efficiency and reduce a current registration backlog. Faster registration of new priority antimalarial health technologies, including diagnostic tests and medicines, is an acknowledged essential step in achieving malaria elimination by 2030.

TGA activities in Lao PDR are funded by the Australian Department of Foreign Affairs and Trade (DFAT) Indo-Pacific Health Security Initiative. This technical support is coordinated by the Regional Regulatory Partnership for Malaria Elimination (RRP), a partnership of nine participating countries in the Asia Pacific, the World Health Organization (WHO), United States Pharmacopeia (USP), the NUS Centre of Regulatory Excellence (CORE) and the TGA, and convened by APLMA.

The latest country mission will inform a longer-term project design under the RRP to strengthen regulatory capacity in Lao PDR, ultimately contributing to better access to medical products to help improve health security.

As part of this visit, APLMA team members met with the Centre for Malaria Parasitology and Entomology (CMPE) and the World Health Organization (WHO) Lao PDR Country Office to align priorities and to assess the status of drug-resistant malaria in the country. Lao PDR is currently revising its treatment guidelines for Plasmodium vivax (which accounts for about 60% of the malaria burden in the country [1]) to include primaquine. In addition, pilot studies will commence this year to test the efficacy of two new artemisinin combination therapies: an artesunate–mefloquine combination and Pyramax, a fixed-dose combination of pyronaridine and artesunate.

APLMA warmly thanks the FDD and CMPE for their hospitality and continued commitment towards malaria elimination.

[1] World Malaria Report 2017. Geneva: World Health Organization; 2017.