Proposed Model to Build Capacity for Emergency Use Authorization for Therapeutics: Guidance for National Medicine Regulatory Authorities

The new Emergency Use Authorizations for Therapeutics: Guidance for National Medicine Regulatory Authorities, provides practical guidance to MRAs on adopting, implementing, and managing expedited approval pathways for therapeutics (drugs and non-vaccine biological products). The guidance provides recommendations for therapeutics emergency use authorization (EUA) and examples of different approaches Medicine Regulatory Authorities (MRAs) in low, middle, and high-income countries have taken to address these recommendations. The goal of this resource is to facilitate rapid access to safe, effective, and quality therapeutics in response to public health emergencies and to facilitate greater international collaboration, harmonization, and data sharing between MRAs. The primary audience for this guidance are MRAs and other stakeholders in countries that have yet to reach Maturity Level 4 (ML4) based on the WHO Global Benchmarking Tool. This guidance should be useful to MRAs without a current EUA pathway and to MRAs looking to strengthen their existing EUA framework.