- West Africa Medicines Regulation Harmonization Initiative

Author: WAHO

Category: Clinical Trials, Pharmacovigilance and Medicines Safety

Language: English

Description This Guideline is hereby made by WAHO with references from FDA Ghana, Pharmacy Board of Sierra Leone, MCC South African, ICH and WHO to define the general norms and scientific principles and to set applicable standards for the conduct, performance and control of clinical trials in human beings in West Africa particularly in relation to granting of marketing authorization.

Abstract This guideline provides clearly articulated standards of good clinical practice in research that are also relevant to local realities and contexts and to ensure that clinical trials conducted on human participants are designed and conducted according to sound scientific and ethical standards within the framework of good clinical practice. These Guidelines are addressed to investigators, pharmaceutical manufacturers and other sponsors of clinical trials whether for academic purposes or for generation of data intended for inclusion in the regulatory submissions for medicinal products. They are intended to be applied during all stages of drug development both prior to and subsequent to product registration and marketing.

Essential Medicines & Vaccines

WAHO Guideline for Application and Authorisation of Clinical Trials of Medicinal Products