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.

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) organised during September 20-24 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 Immunisation.

The improvement, effective from August 27, 2021, also reflects Thailand’s aspiration to be a trusted authorisation 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.

Meanwhile the Centre for Covid-19 Situation Administration (CCSA) said there were 10,817 new coronavirus cases and 84 deaths today (Oct.10) taking the cumulative confirmed total since April 1 to 1,682,021.

Of the new batch of cases 10,055 emerged in surveillance and healthcare systems, 649 were found through proactive search in communities, 50 fell sick in prisons and detention centres while 63 foreign arrivals tested positive.

Another 9,981 patients were cured taking total recoveries since April 1 to 1,554,887 while 110,880 are still undergoing treatment.

At the same time the Bangkok Metropolitan Administration revealed that there were 879 cases across all 50 districts today (Oct. 19) with Don Mueang and Thonburi logging the highest number of cases at 42 each.

The top 10 districts report the most cases today is as follows: 

– Don Mueang, 42;

– Thonburi, 42;

– Bang Khun Thian, 38;

– Ratchathewi, 36;

– Rat Burana, 32;

–  Saimai, 32;

– Bangkok Noi, 28;

– Bangbon, 28 ;

– Yannawa, 25;

– Chomthong, 24. 


Top: Dr Alireza Khadem, one of the three WHO evaluators, (right)  discusses with officials from the Thai FDA during the assessment mission, on June 1, 2021.

Home Page: The Bangkok Metropolitan Administration’s mobile vaccination bus made a stop at Bang Kho Laem district to offer Covid-19 vaccine to vulnerable people in local communities recently. Photo: NNT

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