The Process of Acquiring WHO ML3 Status: Insights from the Serbian National Regulatory Authority

Understanding WHO’s Global Benchmarking Tool

As part of the VISION project, an online webinar explored the process of achieving Maturity Level 3 (ML3) under the World Health Organization’s (WHO) Global Benchmarking Tool (GBT), highlighting the role of regulatory systems in supporting vaccine quality, safety, and manufacturing.

The session was presented by Dr. Vera Simic, Expert Associate for Laboratory Testing and Vaccine Lot Release at the Institute of Virology, Vaccines and Sera “Torlak” in Serbia. Drawing on the Serbian experience, the webinar offered insights into the regulatory development process and its implications for vaccine production.

The pathway towards ML3 maturity

The WHO Global Benchmarking Tool is used to evaluate national regulatory authorities (NRAs) against established indicators of regulatory system performance. Achieving ML3 indicates that a regulatory system demonstrates a stable, well-functioning level of performance and meets the relevant WHO maturity requirements.

The webinar examined the process of progressing towards ML3, addressing the importance of developing regulatory capacities, strengthening institutional processes, and ensuring that regulatory functions operate effectively and consistently.

Collaboration between regulators and vaccine manufacturers

A key theme of the session was the relationship between national regulatory authorities and vaccine producers. Dr. Simic highlighted the importance of communication and collaboration between these stakeholders in supporting regulatory development and facilitating vaccine manufacturing activities.

A WHO-verified ML3 status can also be an important milestone for countries seeking to strengthen their vaccine production capabilities and support future manufacturing projects. Effective regulatory oversight helps build confidence in the quality and safety of vaccines while contributing to a more robust environment for vaccine development and production.