Strengthening national regulatory authorities to ensure safe and effective health technologies

Por Access and Delivery Partnership

WHO evaluators discuss with officials from the Thailand Food and Drug Authority during an assessment mission in June 2021. Photo: WHO

Improving access to medicines and other medical products is a critical public health priority and a fundamental requisite for universal health coverage. The national regulatory system assesses and monitors the safety, quality and efficacy of all medical products introduced into a country, including medicines, vaccines, blood and blood products, and medical devices such as in-vitro diagnostics, among others. However, the World Health Organization (WHO) has estimated that fewer than 30 percent of the world’s regulatory authorities have sufficient capacities to perform all of the required functions to ensure medicines, vaccines and other medical products are safe and effective.

Where medical products are of substandard quality, or are improperly produced, stored or transported, or where they are falsified, used incorrectly or abused, they pose significant risks to public health, and can lead to hospitalization or death.

Over the last several decades, the WHO Regulatory Systems Strengthening programme has developed and refined a robust model of technical support that involves the assessment of regulatory systems and functions using a standardized tool—the Global Benchmarking Tool (GBT)—and the formulation of institutional development plans (IDPs) that are designed to assist countries in implementing effective regulatory oversight. IDPs provide a blueprint to inform and guide government investments and the provision of technical assistance by WHO and other development partners. Coupled with the GBT indicators, the IDPs also provide an objective baseline to monitor and encourage progress.

Working with the Access and Delivery Partnership (ADP) in recent years, the national regulatory authorities (NRAs) in a number of ADP focus countries have attained a high level of capacity improvement, as indicated by WHO’s benchmarking process.

Strengthening national regulatory authorities to ensure safe and effective health technologies

The NRAs in Ghana, India, Indonesia, Tanzania and Thailand have achieved maturity level 3 (against a highest of level 4) for their vaccine regulatory systems. Two of the countries—Tanzania and Ghana—have achieved maturity level 3 for both their medicine and vaccine regulatory systems.

Maturity level 3 confirms a stable, well-functioning and integrated regulatory system is in place. This means that these countries have made considerable improvements in recent years, following WHO’s guidance based on assessments made by the GBT, to ensure medical products within their health systems are of good quality and safe, and produce the intended health benefits.

Notably, Tanzania and Ghana are the first two countries in Africa to achieve this milestone.

Most recently, Thailand also achieved this milestone in September 2021. Over the years, the Thailand Food and Drug Authority (FDA) has enhanced its regulatory system for vaccines to meet increasing domestic demands, especially for the 10 vaccines provided to children in its Expanded Programme on Immunization. The improvement also reflects Thailand’s aspiration to be a trusted authorization body to allow for export of domestically produced vaccines, contributing to the regional and global vaccine supply. Accelerated efforts are ongoing in the country to expand the Thailand FDA’s increased maturity level to medicines and other medical products.

Additionally, ADP is currently supporting the development and implementation of IDPs for NRAs in Bhutan, Burkina Faso, Malawi and Senegal.

Further information:

WHO, ‘WHO Global Benchmarking Tool (GBT) for evaluation of national regulatory systems’

WHO, ‘List of National Regulatory Authorities (NRAs) operating at maturity level 3 and maturity level 4’

WHO, ‘Manual for benchmarking of the national regulatory system of medical products and formulation of institutional development plans’, February 2021

This is part of a collection of impact stories highlighting the work of the Access and Delivery Partnership in ensuring access to health technologies for those in need. For more information and to read additional impact stories, please visit the ADP website.