Regulatory & Governance

Strong regulation and governance are essential for building a safe, effective, and sustainable vaccine manufacturing system. It ensures vaccines meet quality standards, can move across borders, and reach people efficiently. Turning political commitment for regionalized vaccine manufacturing into action - through laws and policies that support regional cooperation - will be critical to making this system work in practice.

While many countries are strengthening their national regulatory systems, regional alignment remains limited. No region has yet achieved full regulatory harmonization, meaning manufacturers often face multiple approval processes to supply across borders. As a result, pathways such as WHO Prequalification remain critical for enabling exports, particularly for access to global markets.

To move forward, countries will need to better align national laws and policies with regional goals. For example, approaches such as regional regulatory reliance and mutual recognition can help reduce duplication and speed up approvals, but require governments to put in place the legal and institutional frameworks to support them.

Tracking this progress remains challenging. For example, there is limited visibility on how political commitments are being translated into concrete legal and policy changes. While this data gap persists, examining related indicators such as regulatory strength and regional scale can help gauge whether these efforts are delivering results.

Regulatory Strength

Strong regulatory performance enables locally produced vaccines to gain approval from well-functioning national authorities and, where needed, through WHO prequalification, helping ensure they can be safely used and supplied beyond domestic markets.

Most vaccines produced in the three regions are approved by national regulators that meet internationally recognized standards, making them eligible for export. This is particularly the case in ASEAN and LAC, where the majority of vaccines fall into this category. However, only a small share of vaccines have achieved WHO prequalification, which is often required for broader international supply. This reflects the fact that many manufacturers still focus mainly on domestic markets.

To move forward, achieving and sustaining higher levels of regulatory maturity remains important to ensure vaccine quality and safety. However, progress also depends on creating more integrated regional markets through advancing regional regulatory frameworks, such as reliance mechanisms and mutual recognition, alongside supporting manufacturers in being ready for regulatory assessments, such as WHO prequalification.

Regulatory Strength

Regulatory Strength

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