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To provide innovative, quality and sustainable ICT solutions and services that meet the aspiration African Medicines Regulatory Agency in term of communication, collaboration, harmonization, reliance and convergence of medicine regulations in Africa.
A trusted role model for sustainable regulatory harmonization and convergence for all using Information and Communication Technologies
In this edition:
Introduction
An overview of 2021 highlights
The months ahead – plans for AU-3S in 2022
Country Focus: Med Safety App use in South Africa
Scaling up data sources into AU-3S DISD system
Update on AU-3S JSM Group
AU-3S capacity strengthening training…
WHO Global Model Regulatory Framework (GMRF) for Medical Devices and IVDs recommendations adopted by members.
Regional, continental, and internationally harmonized technical guidelines relating to Medical Devices and IVD Medical Devices developed and implemented
Increased awareness of…
Capacity building on registration and common dossier submissions; quality audit and inspection; clinical performance studies; and post-market surveillance.
Conducting training programmes and providing resources to NRAs as part of capacity building.
The purpose of the Forum is to establish a harmonized framework for regulation of medical devices including in vitro diagnostics (IVDs) in Africa based on the WHO Global Model Regulatory Framework for Medical Devices including in vitro diagnostics
To study and recommend ways to harmonize medical devices and diagnostics regulation in Africa.
Capacity building on registration and common dossier submissions; quality audit and inspection; clinical performance studies; and post-market surveillance.
Conducting training programmes and providing resources to NRAs as part of capacity building.
The objectives of AVAREF, are as follows:
To effectively provide timely and relevant information to African countries which are targeted for clinical trials of medicines, and updates on clinical development of relevant products.
To provide expertise to and to enhance capacity for African…
AVAREF will expand its responsibilities and activities in a step-wise manner from vaccines to include all medical products and geographically to include all African countries. As such, AVAREF represents the first pan-African medical products regulatory network in fulfilment of the goals of AMRH,…
