📋 Tender Overview
Project Name
Strengthening Regulatory Ecosystem and Manufacturing for Vaccines, Therapeutics, and Diagnostics in Asia and the Pacific (REVITALIZE)
Project Number
58071-001
Country / Economy
Regional
Bangladesh
Indonesia
Pakistan
Project Status
Active
Project Type / Modality of Assistance
Technical Assistance
Source of Funding / Amount
TA 10528-REG: Strengthening Regulatory Ecosystem and Manufacturing for Vaccines, Therapeutics, and Diagnostics in Asia and the Pacific (REVITALIZE)
Republic of Korea e-Asia and Knowledge Partnership Fund US$ 1.00 million
Sector / Subsector
Health / Disease control of communicable disease
Gender
Effective gender mainstreaming
Description
The technical assistance (TA) will support Asian Development Bank (ADB) developing member countries (DMCs) through capacity building to strengthen their regulatory ecosystems for vaccines, therapeutics, and diagnostics (VTD). The strengthened regulatory capacities will help DMCs prepare, prevent, and respond to future disease outbreaks and pandemics. The TA will initially support Bangladesh, Indonesia, and Pakistan. Additional DMCs will be considered based on their regulatory needs, government commitment, regional relevance, and potential for scalable impact.
The TA will support the implementation of ADB's Strategy 2030, particularly operational priority (OP) 1 (addressing remaining poverty and reducing inequalities), OP3 (tackling climate change, building climate and disaster resilience, and enhancing environmental sustainability), and its focus area of enhancing human capital and social protection for all.
Project Rationale and Linkage to Country/Regional Strategy
The coronavirus disease (COVID-19) pandemic highlighted significant vulnerabilities in the global vaccine security system, which was intended to ensure equitable access to quality vaccines on an affordable and timely basis. Access to vaccines are critical for the prevention of, and response to, outbreaks, epidemics, and pandemics; and delayed access was evident globally and in Asia and the Pacific during the pandemic. Therefore, regulatory ecosystems and capacities for VTD need to be strengthened as they are critical for ensuring vaccine security in the region.
National regulatory authorities (NRAs) are responsible for the safety, quality, and efficacy of VTDs. NRAs supervise and implement drug regulations and regulate activities related to importing and procuring raw materials and packaging. They regulate the export of finished drugs, diagnostics, equipment, diagnostic reagents, biotherapeutics, and vaccines. An effective and fully operational regulator is essential to ensure pharmaceutical products' safety, efficacy, and quality. Robust regulatory oversight is pivotal in fostering a sustainable, quality-focused local vaccine manufacturing base. Clear regulatory guidelines and requirements can promote the development of safe and effective VTDs. Regulatory pathways are also critical entry
