Regional Director’s Welcome Address at the Regional Hybrid Workshop on Optimizing the Use of Reference Standards, Bangkok, Thailand,

14 May 2024

Esteemed Hosts from the Ministry of Public Health Thailand, Distinguished Guests, Esteemed Colleagues, Scientists, Specialists, Civil Servants, Development Partners, Academics, and WHO Representatives,

A warm greeting to each of you, and a heartfelt welcome to this Regional Hybrid Workshop focusing on Optimizing the Use of Reference Standards.

First and foremost, I extend my sincere gratitude to the Department of Medical Sciences in Thailand for graciously hosting this gathering. Their status as a WHO prequalified Quality Control Laboratory speaks volumes about their commitment to excellence.

Thailand's leadership within the South-East Asia Regulatory Network (SEARN) is exemplary, characterized by active engagement and valuable contributions to SEARN's drafting groups and working bodies. Moreover, Thailand's pivotal role in the ASEAN Working Group on Pharmaceutical Development as Coordinator, Regional Training Center, and producer of ASEAN Reference Substances is commendable.

Reference standards, including biological reference standards, are indispensable tools for our National Quality Control Laboratories (NQCLs). They underpin the essential task of assessing the quality, safety, and efficacy of medical products, thereby safeguarding public health, and advancing Universal Health Coverage.

Indeed, the access and utilization of Reference Standards are pivotal in our pursuit of Universal Health Coverage. SEARN members have consistently voiced challenges in accessing reference standards, especially amidst the COVID-19 pandemic, where the need for robust quality testing of medical products has been paramount.

The lack of access to Reference Standards for certain products, such as Covid-19 vaccines, coupled with challenges in sourcing and high procurement costs, has underscored the urgency of addressing this issue.

The adoption of a Strategy by the SEARN Assembly in July 2023 to enhance access and use of reference standards is a laudable step forward. This Strategy, which includes the organization of this workshop and a feasibility study on regional secondary reference standard production, reflects our collective commitment to addressing this critical issue.

We eagerly anticipate the preliminary findings of this study, to be presented later today.

Partnerships and collaboration lie at the heart of our endeavors, and I am delighted that this workshop provides an opportunity to enhance coordination with other initiatives, such as the WHO Network of National Control Laboratories for Biologicals.

This collaborative effort aims to establish a Diagnostics and Vaccines Library of Standards and Reagents in the region, facilitating access for regulators and the industry alike. However, it is essential to recognize that improved access to reference standards alone cannot ensure the quality of medical products.

It must be complemented by other measures, including the rational use of these standards, regional cooperation in testing and information sharing, strengthening regulatory systems, and prioritizing tests based on risks.

The significance of these efforts cannot be overstated; they are quite literally lifesaving. I wholeheartedly endorse SEARN's ongoing endeavors to strengthen cooperation among NQCLs. Rest assured; our WHO Regional Office stands ready to lend its unwavering support to these endeavors.

I wish each of you a fruitful and productive experience over the next two days. I urge you all to actively engage and contribute, ensuring that the needs of your respective countries are voiced and addressed. May this workshop be a resounding success, and I eagerly await the outcomes. Once again, please accept WHO's steadfast commitment to supporting your endeavors.

Thank you.