Improving registration pathways for priority antimalarial products in Lao PDR




National partners are coming together in Vientiane, Lao PDR this week in an effort to strengthen regulatory capacity for the registration of new and priority medicines and diagnostic tests. The initiative is being led the Australian Therapeutic Goods Administration (TGA), the Australian Department of Foreign Affairs and Trade (DFAT) and the Asia Pacific Leaders Malaria Alliance (APLMA).

Fast tracking the registration of new and priority medicines and diagnostic tests is an essential step to achieving malaria elimination by 2030. TGA, DFAT and APLMA are working closely with the Lao PDR Food and Drug Department (FDD), the Bureau of Food and Drug Inspection (BFDI) and the Centre for Malaria Parasitology and Entomology (CMPE) – focusing first and foremost on market authorization and registration.

The initiative is part of the work of the Regional Regulatory Partnership for Malaria Elimination (RRP), and is funded by the Australian Government’s Health Security Initiative for the Indo-Pacific Region. The technical support provided by the TGA is based on the validated RRP Workplan and is aimed at building regulatory capacity where it is most needed. These efforts will also serve to improve broader health security by improving rapid access to other priority medical products. This is also important in light of the threat posed by drug-resistant malaria, emerging in the Greater Mekong Subregion.

Despite important progress in the fight against malaria leading to a 46% reduction in malaria-related deaths1, 96% of Laos’ population is still at risk of the disease.2 Strengthening Lao PDR’s medical product regulatory system forms part of the solution to strengthening the momentum towards malaria elimination.

Lao PDR is dedicated to the elimination of malaria by 2030 and has demonstrated a strong commitment to addressing priority gaps in both the registration and market authorization of new and existing priority antimalarial products. Dr Bounxou, Deputy Director of the FDD, as well as Dr Simone Nambanya, Deputy Director of the CMPE, actively participated in the Third WHO RRP Workshop held in Ho Chi Minh City, Viet Nam in August 2017, where the priority workplan for regulatory systems strengthening was developed and validated. Dr Nambanya also highlighted the relevance of regional collaboration and sharing best practices between country members of the RRP.

We would like to thank the FDD, BFDI and CMPE in the Lao PDR for their commitment towards malaria elimination and towards the RRP.

1 Kouunnavong et al. (2017) Malaria elimination in Lao PDR: the challenges associated with population mobility, Infectious Diseases of Poverty, 6(81) pp. 1-9.

2 World Malaria Report 2017. Geneva: World Health Organization; 2017.

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