- West Africa Medicines Regulation Harmonization Initiative

Author: WAHO

Category: Clinical Trials, Pharmacovigilance and Medicines Safety

Language: English

Description The guideline has been developed by AVAREF and adopted by WAHO to provide a model of joint scientific review of CTAs by NMRAs and ECs. This model may also be applied to the review of unconventional regulatory pathways at different stages of the product lifecycle. This guideline is intended to assist WAHO, individual countries and sponsors in how to plan, organize and conduct joint review of applications for medical products. The guideline is not intended to replace but rather facilitate compliance with the regulatory requirements of countries in the review, approval and authorization of medical products clinical trials as outlined in each country legislation. ECOWAS countries are encouraged to consider this joint review model into their review process as a means of fulfilling regulatory requirements. This guideline should be used together with WHO’s Technical Report Series on review of clinical trials (WHO Technical Report Series No 924-Guidelines on Clinical Evaluation of Vaccines: Regulatory expectations) and other international guidelines for the review of CTAs by ECs/institutional review boards (IRBs) and NMRAs. It is also expected that WAHO will serve to promote convergence of CTA technical requirements and processes. The guideline is subject to amendment as further experience is gained with the joint review process

Abstract The guideline covers all aspects of the joint review of a qualifying medical product 1 using the WAHO platform specifically: • Conditions or requirements for joint/assisted reviews, including criteria for triggering a review; • Key participants as well as their roles and responsibilities in the review process; • The stops and time lines interview process, from pre-submission meeting to the conclusion of the joint review exercise; • Expected outcomes from the joint review process; and post-review steps leading to the commencement of the clinical trial

Essential Medicines & Vaccines

WAHO Guideline for Joint Review of Clinical Trial Application