Global Vaccine Safety

Regulatory framework

To promote a legal, regulatory and administrative framework for the safety of vaccines at national, regional and international levels.

Vaccine safety systems are rarely effective without strong regulatory support. Evidence shows that clear requirements, clear responsibilities and the enforcement of appropriate regulations help to protect health. The monitoring and management of vaccine safety concerns requires an officially prescripted systematic approach. The Global Vaccine Safety Initiative will promote a routine and functioning system for regular review of the safety and efficacy of specific vaccines.

WHO already has a system in place for the assessment of national regulatory authorities, which are the bodies responsible for ensuring that pharmaceuticals and biological products such as vaccines meet international standards of quality and safety. The assessment helps the authorities to recognize gaps in their critical functions and to identify solutions.

Few vaccines are used only in one country, so vaccine pharmacovigilance is an international responsibility. The GVSI will develop an international mechanism for the exchange of information about AEFI and vaccine safety.


February 2018

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Global Vaccine Safety Initiative
World Health Organization