The Centre for Health Security and the Australian Department of Health’s Therapeutic Goods Administration (TGA) launched the Indo-Pacific Regulatory Strengthening Program on 3 October 2018, alongside the ASEAN Regulators' Roundtable in Singapore. Six countries in the Indo-Pacific region: Cambodia, Indonesia, Myanmar, Papua New Guinea, Vietnam and Laos PDR, will participate in the program.
National Regulatory Authorities are responsible for registering medical products in their respective countries. The program aims to strengthen the capabilities of National Regulatory Authorities in the Indo-Pacific region, and improve access to quality registered medical products, mitigating diseases threatening public health.
“TGA is proud to collaborate with its counterparts to strengthen their regulatory practices. The TGA is pleased to provide support to help increase the availability of safe and effective medical products, most immediately for malaria and tuberculosis,” said Adjunct Professor John Skerritt, who leads Australia’s TGA.
Under-regulated medical products can hinder national disease control efforts and drive antimicrobial resistance, threatening neighbouring countries and the region. Close coordination between National Regulatory Authorities and national disease control programs improves access to good quality and appropriate medicines and medical devices.
“Building the regulatory capacity will accelerate safe access to new medical products, and complements Australia’s support for medical research,” emphasised Madeleine Moss, Deputy Head of the Indo-Pacific Centre for Health Security.
This program is all about ensuring the fruits of ground-breaking research can benefit the people who most need it.” Ms Moss continued.
The Indo-Pacific Regulatory Strengthening Program will build on the valuable foundational work of the Regional Regulatory Partnership for Malaria Elimination, and ease the challenges brought by the significant burden of drug-resistant disease across Southeast Asia.
Under the Program, Australia’s TGA will provide technical advice and assistance to the participating National Regulatory Authorities, to build internal capabilities through regular in-country missions, workshops, training events, information sharing activities and placements in Australia. To build technical knowledge, training and graduate certificates will be provided by the Centre of Regulatory Excellence at Duke-NUS in Singapore. This program will work closely with the World Health Organisation to support partner countries.
DFAT’s Indo-Pacific Centre for Health Security and the TGA will provide oversight of the Program.