- 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 Good Pharmacovigilance guidelines Nigeria, 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 pharmacovigilance activities in West Africa.

Abstract underlying objectives of this guideline are to: • harmonize the requirement for reporting adverse reactions in humans arising from the use of Authorized medicinal products within or outside the terms of marketing Authorization; • promote the safe and effective use of medicine, in particular through providing timely information about the safety of medicine to patients, healthcare professionals, marketing Authorization holder and the public. • contribute to the protection of patients’ and public health.

Essential Medicines & Vaccines

WAHO Guideline on Good Pharmacovigilance Practice