Partners, Colleagues, Associates and Friends
Good morning, and welcome to this important workshop, bringing together vaccine regulators, manufacturers, and stakeholders from our South-East Asia Region.
We are here to advance five overarching and interrelated objectives:
First, understanding the manufacturing and testing processes for vaccines produced through emerging novel technologies.
Second, increasing the capacity of national regulatory authorities (NRAs) in assessing the dossiers of vaccines produced through novel technologies through multi-faceted collaborations.
Third, developing models for efficient use of limited NRA resources for implementing Good Reliance Practices for vaccines.
Fourth, developing expertise in new approaches in regulatory inspection practices for multi-product facilities with rapid campaign changes and online tools.
And fifth, evaluating and approving warm bases of vaccine manufacturing with minimal and low level of production, while cognizant of potential increase in production due to a pandemic onset and resultant increase in demand.
Since the COVID-19 pandemic, there has been a strong drive to diversify vaccine manufacturing capacity, so all regions are better able to produce vaccines to meet regional needs, particularly during pandemics. WHO supports Member States, particularly low- and middle-income countries, to strengthen sustainable local production and technology transfer. This is to improve timely, equitable access to quality, safe and effective essential medical products. Our Region is a global hub for vaccine production, and manufacturers based here are meeting almost 50% of global demands of EPI vaccines supplied through UN agencies.
The COVID pandemic has been the catalyst for change in global and regional regulatory practices. The new regulatory issues included a considerable increase in workload requiring inter NRAs collaborative oversight of global supply chains, while knowledge and technologies related to vaccine development and manufacturing were rapidly evolving.
The Good Reliance Practices (GRP) defines reliance as when ‘the regulatory authority in one jurisdiction considers and gives significant weight to assessments performed by another regulatory authority.’ COVID-19 proved to be a real catalyst to moving reliance from theory to real-life implementation, as reliance played a crucial role in facilitating access to COVID-19 vaccines.
The highest level of collaboration, information sharing, coordinated actions, and reliance is required from regulators in response to a public health emergency.
A landmark resolution WHA74.6 on strengthening local production of medicines and other health technologies to improve access was adopted in the Seventy-fourth World Health Assembly, signaling the important role, local production plays in improving access and strengthening health security.
Currently, many new vaccines based on novel technologies such as mRNA are being developed such as Dengue, Rabies, RSV, Yellow fever, and multivalent COVID-19 vaccines.
The WHO initiative for the set-up of the WHO Listed authorities will also create great opportunities for reliance, as it will clearly define which regulatory authority can be relied upon and for which specific regulatory function.
The implementation of GRP will ensure that redundancy of regulation is avoided, saving many NRA resources which can be utilized for other mandatory functions such as Pharmacovigilance, Vaccine Safety, AEFI management, Market Control and Licensing of Establishments.
As I conclude, I would like to wish you all productive deliberations, and look forward to the outcomes of this Regional Workshop.
Thank you.