Distinguished representatives of Ministries of Health and National Regulatory Authorities
Directors and experts from National Quality Control Laboratories
Director and Representatives of the National Institute of Biologicals
Colleagues from CEPI, WHO Headquarters and our partner organizations
Ladies and Gentlemen
A very good morning to everyone.
The WHO South-East Asia Region is one of the world’s leading producers of vaccines and biological products.
It supplies a substantial proportion of global demand and plays a critical role in ensuring equitable access to life-saving medical products.
The Region is also rapidly emerging as an important centre for in vitro diagnostic (IVD) manufacturing.
With this responsibility comes the need for strong regulatory systems and robust quality assurance.
Biological reference standards are an essential part of that system.
These reference standards are largely invisible to the public.
Yet without them, laboratory testing loses its reliability, and regulators lose a basis for consistent decisions.
Without them, countries lose the means to confirm that vaccines, biological medicines, and in vitro diagnostics are high quality, safe, and effective.
Reference standards also underpin the capacity of countries to manufacture these products locally.
The COVID-19 pandemic tested this system directly.
We saw that preparedness depended not only on manufacturing capacity, but also on the scientific infrastructure to evaluate and monitor medical countermeasures quickly.
Access to biological reference standards became a bottleneck worldwide for regulators and manufacturers alike, a lesson that continues to shape how countries prepare for the next health emergency.
SEARN responded with a regional strategy to strengthen access to reference standards and their use across Member States.
A first workshop in Bangkok in 2024 addressed chemical reference standards.
This one takes the next step: biological reference standards.
Importantly, this workshop is not only about understanding reference standards.
It is about building a more connected regional system: one where countries share expertise, strengthen laboratory capacity, promote regulatory convergence, and expand access to quality-assured medical products across South-East Asia.
Your discussions here will shape SEARN’s future strategy on biological reference standards.
They will also inform our broader regional efforts to strengthen the biological reference standards ecosystem, including its role in pandemic preparedness and response.
Your outcomes will also feed into an upcoming workshop dedicated to that broader ecosystem.
WHO remains fully committed to supporting Member States in this vital work.
But its success depends on more than WHO alone. It depends on all of us: on sustained collaboration, mutual trust and collective ownership among our national institutions.
I encourage you all to engage actively, share your experiences openly, and identify practical solutions that can be translated into concrete actions.
I would like to thank the National Institute of Biologicals for hosting us, and CEPI for the generous support that made this workshop possible.
My thanks also to every participant and partner who has travelled from across the Region and beyond to be here.
I wish you a productive workshop, and look forward to being apprised of the outcomes.
Thank you.