Opening Remarks by Dr Shin Young-soo, WHO Regional Director for the Western Pacific, at Workshop on procedure for Expedited Review for Imported Prequalified Vaccines for use in Immunazation Programmes

Manila, Philippines
3 December 2012


Good morning and welcome to this important workshop.

As always, it is a pleasure to see you here in the Regional Office.

As you know, vaccination programmes prevent the death of millions of children each year in the world.

In fact, immunization is the single most effective way to reduce the burden of diseases and their devastating toll on development.

Over the years, WHO's immunization programmes have grown tremendously to meet the demands of Member States as they strengthen national programmes to increase access to immunization.

Today, the Expanded Programme on Immunization in member states offer protection against 12 diseases and reaches more than 100 million children each year worldwide.

But we cannot rest on our successes….

We must continue to ensure the quality, safety and efficacy of vaccines through independent and functional regulatory systems, applying strict international standards.

WHO has played a strong role in helping countries to build their regulatory capacity.

But most countries in the Region still do not have functional regulatory systems for vaccines.

As of October, only seven countries in the Western Pacific Region — including China most recently — have been rated as having functional regulatory systems.

Four of those seven countries, in fact, are vaccine producers.

Now WHO is supporting China in its vaccine prequalification process for UN procurement.

The addition of China would boost vaccine production in the Region and help fulfil the goal of making quality-assured vaccines at affordable price.

At present, 19 countries in the Region still rely on the United Nations procurement system for most of their vaccine needs.

The UN procurement system helps countries without a functional regulatory system to obtain safe and effective vaccines.

These countries, however, still should carry out two regulatory functions 1. marketing authorization and licensing activities 2. pharmacovigilance activities including surveillance of adverse events following immunization.

In recent years many countries have asked for regional mechanisms to establish or strengthen their regulatory systems.

During the first workshop for national regulatory authorities last year in Seoul, countries tasked the WHO Regional Office to establish such an alliance for national regulatory authorities for vaccines.

I am pleased to inform you that we have formed the taskforce committee for formulating Regional Alliance for NRAs for vaccines and completed the concept paper and work plan.

These documents have already been shared with countries and we are planning to finalize them in 2nd NRA workshop in March 2013.

At this workshop, you will be discussing the newly developed WHO procedures to expedite licensing of prequalified imported vaccines for immunization programmes.

This procedure will help countries fulfil their licensing obligation while they take another step towards the creation of a functional national regulatory authority.

Thank you for participating in this workshop and embracing the life-saving role you play in strengthening regulatory capacities.

I wish you successful deliberations and look forward to seeing the outcomes of your work.

Enjoy your stay in Manila.