The purpose of this document is to guide and assist ethics committees (ECs) and national regulatory authorities (NRAs) to plan, undertake expedited reviews and approvals of clinical trial applications, and provide oversight of trials during a pandemic or epidemic. This strategy is consistent with national emergency preparedness and response plans for public health emergencies.

It is also intended to inform and guide regulators and ethics committees of the Regional Economic Communities (RECs) in Africa and sponsors on the critical elements of emergency preparedness to ensure that ethics and regulatory decisions do not constitute barrier to access, but rather promote public health. Ultimately, the intention is to facilitate compliance of all stakeholders with the ethics and regulatory requirements of countries in the review and approval of clinical trials of medicines and vaccines as outlined in each country’s regulatory frameworks.

This document does not replace national guidelines and processes for reviews of clinical trial applications and should be used together with the provisions of WHO’s Technical Report Series on review of clinical trials, WHO Technical Report Series No 924 (Guidelines on Clinical Evaluation of Vaccines: Regulatory Expectations), together with related WHO documents 3,4,5,6 and other related international guidelines.