Speeding up the registration of priority tests and treatments in Vietnam

Efforts to strengthen medicines regulation and accelerate the registration of tools to test and treat malaria are underway in Vietnam. Following the launch of the Indo-Pacific Regulatory Strengthening Program (RSP), the Australian Therapeutic Goods Administration (TGA) together with APLMA visited Viet Nam for a scoping mission this week, the 5th mission in the region since December 2017.

The purpose of the scoping mission is to work in partnerships, build on existing systems, and improve and streamline regulation of medicines and diagnostics, in line with WHO and ASEAN guidelines. By doing so, it is hoped that specific bottlenecks can be addressed and opportunities for improving the timeliness of registrations can be explored. The TGA conducted similar missions in Myanmar, Lao PDR, PNG and Indonesia.

In Vietnam, challenges in medicine regulation include large volumes of applications received leading to backlogs and delays. Recent evidence shows drug resistant malaria spread from Cambodia to Southern Vietnam, including the Bin Phuoc province of Vietnam and 4 other provinces.1 Malaria in the Greater Mekong Sub-region could become incurable unless new Artemisinin Combination Therapies (ACTs) are distributed, and this calls for faster registration of other ACTs.

During the mission to Hanoi, The TGA and APLMA jointly met with the Drug administration of Vietnam (DAV), the Department of Medical Equipment and Construction, Disease Programs and WHO. Over the course of three days, we identified tangible ways to reduce timelines from the submission of a dossier to the registration of a new drug. The DAV requested support in building the expertise of their staff for the evaluation of new drug applications and post market surveillance.

The team also met with the National Malaria Program National Institute of Malariology Parasitology and Entomology (NIMPE) to present the RSP program and understand registration priorities for new malaria commodities. This builds on APLMA and APMEN's ongoing collaboration with NIMPE to work towards malaria elimination by 2020 in Vietnam. The TGA will be working closely with identified technical staff in the DAV over three weeks in their next visit in early 2019.

Faster access to priority medicines and diagnostics means countries are better equipped to address emerging and re-emerging health threats including infectious diseases such as malaria and tuberculosis. It is an important pathway to ending these diseases for good.

The scoping mission is part of the broader Regional Regulatory Partnership and TGA’s work in Vietnam is funded by the DFAT Health Security Initiative for the Indo-Pacific Region.