Addis Ababa – Heads of national regulatory agencies and national ethics committees from across Africa have agreed to harmonise their practices to strengthen regulatory oversight of clinical trials.

At the end of a two-day extraordinary meeting of the African Vaccine Regulatory Forum (AVAREF) in Addis Ababa, Ethiopia, consensus was reached to expand AVAREF’s scope and membership as well as to promote collaboration, harmonization of regulatory systems and best practices across the continent. This will be accomplished through a new governance structure that will help provide the foundation for the future African Medicines Agency which is scheduled to be launched in 2018.

The World Health Organization (WHO) established the AVAREF in 2006 to address the increased number of clinical trials, limited infrastructure, limited expertise and unclear operating models in African countries.  The Forum is comprised of the National Regulatory Agencies (NRAs) and National Ethics Committees of 23 countries targeted for clinical trials of HIV, Malaria and TB vaccines.

“As a network of regulatory authorities and ethics committees, AVAREF has over these years strengthened the capacity of countries in Africa to regulate clinical trials, particularly of vaccines and has contributed to access to important vaccines such as the conjugate meningitis A vaccine, thereby helping to significantly reduce epidemics of meningitis”, said Dr Matshidiso Moeti, WHO Regional Director for Africa, in a speech read on her behalf at the landmark event.

“Despite its success, the network still faces some challenges. The time has come for a new vision and blueprint for AVAREF which takes into account the rapidly evolving global and regulatory environment, as well as the opportunities presented by new initiatives”, she added.

Currently African countries face significant regulatory challenges including the increased circulation of sub-standard/spurious/falsely labeled/falsified/counterfeit products, lack of technical expertise and capacity within individual NRAs and Ethics Committees, among others. Similarly product developers face challenges associated with disparate application requirements.

In an effort to address these challenges, participants unanimously agreed to expand the existing AVAREF with a new vision to address evolving global and regulatory challenges. The new AVAREF will be a pan-African network to provide robust clinical trial oversight and enhance other regulatory functions to increase access to safe and effective medical products such as medicines, vaccines and diagnostics for the African population. It will also facilitate increased efficiency and build capacity of its membership.

In his remarks, Dr Vincent Ahonkai, Senior Adviser for Regulatory Affairs, from the Bill & Melinda Gates Foundation (BMGF) noted that this vision is a game changer in the continent’s regulatory environment.  “We are living in an era of cooperative, collaborative networks, and strategic alliances. Building an efficient clinical trial platform is a core component of access to quality health products for Africa. AVAREF aims to build that platform and is a welcome initiative that will benefit the citizens of Africa,” he said.

Speaking to reporters at the event, Dr Thomas Nyirenda, Director at the European and Developing Countries Clinical Trials Partnership (EDCTP) said: “Alignment, harmonization and expansion of the scope of AVAREF taking into account other regional initiatives on the African continent is timely and will complement the efforts of EDCTP which has an expanded mandate to fund all phases of clinical trials for products against targeted diseases”.

Over 70 participants attended the meeting, including delegates from   Member States, Regional Economic Communities, African Union Commission, NEPAD Agency, product developers, development partners and technical experts.