Thailand’s vaccine regulatory system reaches WHO’s second-highest level

The World Health Organization (WHO) has announced that Thailand's National Regulatory Authority (NRA) for vaccines reached Maturity Level 3, the second highest in the WHO classification of national regulatory system, effective from 27 August 2021.

Dr Marieangela Simao, the Assistant Director-General on Access to Medicines and Health Products, announced the news during her opening remarks at the extraordinary virtual International Conference of Drug Regulatory Authorities (ICDRA) organized from 20-24 September 2021.  

WHO classification is carried out by employing WHO's Global Benchmarking Tool (GBT) to ensure vaccines' quality, safety, and effectiveness. The tool assesses the overarching regulatory framework through nine cross-cutting functions with a series of sub-indicators. In June 2021, a WHO team comprising three experts re-assessed Thailand's NRA using an updated and more comprehensive GBT with new functions and benchmarking criteria. This is a follow-up on the earlier country mission in mid-2018.

GBT evaluation results are presented as maturity levels on a scale of 1 to 4. Achieving Maturity Level 1 means some elements of the regulatory system exists. Maturity Level 2 indicates an evolving national regulatory system that partially performs essential regulatory functions. Maturity Level 3 confirms a stable, well-functioning and integrated regulatory system is in place. The highest level, Maturity Level 4, is achieved by a regulatory system operating at an advanced level of performance and continuous improvement.

In recent years, Thailand has enhanced its NRA for vaccines to meet the increasing domestic demands, especially for the set of 10 vaccines provided to children in the Expanded Programme on Immunization.

 The improvement also reflects Thailand's aspiration to be a trusted authorization body so domestically-produced vaccines could be exported, contributing to the regional and global vaccine supply. Accelerated efforts are continuing to expand NRA maturity to medicines and other medical products.

Dr Poonam Khetrapal Singh, WHO South-East Asia, Regional Director, congratulated the country on this recent achievement to H.E. Mr Anutin Charnvirakul, Deputy Primes Minister and Minister of Public Health. This remarkable achievement attributable to the strong leadership of the Royal Thai Government (RTG) and the strong commitment of the Thai Food and Drug Administration (TFDA) reaffirms the continuous collaboration between the Thai government and WHO in achieving universal access to safe, effective and affordable vaccines.

Thailand NRA is now on the list of National Regulatory operating at the maturity level 3 under the WHO-listed authority (WLA). WHO-listed authority (WLA) provides a transparent and evidence-based pathway for 116 regulatory authorities to be globally recognized as meeting WHO and other international 117 recognized standards and practices. The designation of a regulatory authority as a WLA is ultimately meant to promote access and supply of safe, effective and quality medicines and vaccines.

Original article published on WHO Thailand.