Covid-19 vaccines: safety surveillance manual - Regulatory reliance and work-sharing

Overview

Regulatory reliance is defined in the WHO draft guideline on good reliance practice standards as “the act whereby the national regulatory authority (NRA) in one jurisdiction may take into account and give significant weight to assessments performed by another NRA or trusted institution, or to any other authoritative information in reaching its own decision. The relying authority remains independent, responsible and accountable regarding the decisions taken, even when it relies on the decisions and information of others.”.

The levels of reliance between NRAs can range from independent decisions by NRAs (no reliance) to mutual recognition (full reliance). Recognition is a formalized process for reliance, based on legal provisions whereby one regulatory authority recognizes the decisions of a reference regulatory authority, without additional regulatory assessment. Recognition may be unilateral or mutual and several NRAs may participate in the same recognition agreement.