58071-001: Strengthening Regulatory Ecosystem and Manufacturing for Vaccines, Therapeutics, and Diagnostics in Asia and the Pacific (REVITALIZE) (2025)

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.

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 points for evaluating sex- and gender-based differences in terms of the safety, adverse events, efficacy, and effectiveness of VTDs.

DMCs in Asia and the Pacific face serious challenges in regulating VTDs. While regulatory processes for marketing authorization and regulatory inspections are established in many countries, backlogs persist in the registration and inspection of VTDs. This is partly because of the inability of many countries to determine the priority products needed for their population and the lack of capacity to implement risk-based approaches to regulation. Certain regulatory activitiesparticularly monitoring, surveillance, and pharmacovigilance are limited or almost nonexistent in some DMCs. This limited implementation has weakened the tracking of the pharmaceutical and vaccine manufacturing and supply chains, and the adverse drug or vaccine events. This has resulted in counterfeit and substandard products in the informal sector, many of which make dubious or exaggerated claims about their efficacy. Further, sex and gender are not adequately considered in clinical trial design and reporting, as was seen during the development of COVID-19 vaccines.

Challenges are more complex than ever because of (i) the increasingly transnational nature of medicine production and the supply chain, (ii) the rapid evolution of product science and technology, (iii) the increasing expectations by health care providers and patients on product quality, (iv) the continuing need for statutory and technical competence, and (v) the need for low-carbon and climate-resilient production and supply systems. Therefore, collaboration among NRAs is becoming more important than ever, particularly on information sharing, work sharing, and reliance on and recognition of NRAs of the regulatory decisions of other NRAs through multilateral and bilateral agreements.

The development and manufacturing of climate-resilient vaccines, and the design and implementation of climate-resilient vaccine manufacturing technology, are critical especially in the context of global efforts to reduce greenhouse gas emissions. Traditional vaccine production and supply chains are energy-intensive, contributing significantly to greenhouse gas emissions, which exacerbate climate change. By innovating climate-resilient technologies in vaccine manufacturing and supply chain, their carbon footprint can be substantially reduced. Such advancements would ensure that the essential public health benefits of vaccinations are delivered in a more environmentally sustainable way. Moreover, these technologies can help maintain the efficacy and stability of vaccines, including ensuring the availability of raw materials and distribution of vaccines, in the face of increasingly unpredictable and extreme weather conditions brought about by climate change. Integrating climate resilience into vaccine development and production is not only an environmental imperative but also crucial for ensuring vaccine security and safeguarding regional health security in Asia and the Pacific.

The TA will initially be implemented in three DMCs: Bangladesh, Indonesia, and Pakistan. Other DMCs in need will be also considered. The TA is expected to support the implementation of the ongoing Bangladesh Vaccines, Therapeutics, and Diagnostics Manufacturing and Regulatory Strengthening Project under the Asia Pacific Vaccine Access Facility, and provide support to Indonesia and Pakistan for a potential project in the pipeline, including regulatory system strengthening initiative. The TA gender categorization is effective gender mainstreaming.

Strengthened regulatory ecosystem in DMCs, emphasizing climate resilience in vaccine manufacturing, and enhancing regulatory and bio-manufacturing capacities.

Roadmaps for regulatory system strengthening developed in selected DMCs.

Enhanced capacity for regulatory functions in market entry and post-market control.

Technology transfer for VTD manufacturing facilitated.