Who We Are | AUDA-NEPAD- AMRH

About AMRH
AMRH Vision
AMRH Governance Structure
AMRH Steering Committee Members
AMRH Joint Secretariat Members
Current Partners

About AMRH

African Medicines Regulatory Harmonization (AMRH) programme started in 2009 as a response to addressing challenges faced by National Medicine Regulatory Authorities (NMRAs) in Africa. These challenges include; weak or non-coherent legislative frameworks, sluggish medicine registration processes and subsequent delayed approval decision, inefficiency and limited technical capacity, among others. This situation translates in to poor access to priority essential medicines by patients and is a contributing factor to over-priced medicines.

The aim of the programme is to facilitate and coordinate the harmonization of medicines regulation and improve access to quality, safe, efficacious and affordable medicines in Africa as part of the broader African Union Framework on Pharmaceutical Manufacturing Plan for Africa (PMPA). To achieve this aim, AMRH works towards improving medicine registration processes and operational inefficiencies, thereby reducing registration times whilst enhancing the quality of the registration decision. The programme is implemented under the Program Delivery and Coordination Directorate.

AMRH Vision

To ensure that African people have access to essential medical products and technologies.

AMRH Governance Structure

The African Medicines Regulatory Initiative (AMRH) was established in 2009 as part of the Pharmaceutical Manufacturing Plan for Africa (PMPA) to provide an enabling environment for facilitating access to good quality, safe and efficacious medical products and health technologies. The initiative which works through regional economic communities (RECs), has established expert working groups and/or technical working groups and steering committees at regional levels supported technically and strategically by the AMRH Technical Committees and a Steering Committee, at continental level. The African Medicines Regulators Conference (AMRC) serves as the AMRH Assembly and serves as a platform for sharing best practices on regulatory matters and a mechanism for generating technical information to guide AU decision making processes’.

As part of alignment of regulatory systems strengthening (RSS), harmonization efforts and networks across the continent, the AMRH has ten technical committees. They include the African Medicines Quality Forum (AMQF) on quality assurance and post marketing surveillance; the African Medical Devices Forum (AMDF); the African Vaccines and the African Vaccines regulatory Forum (AVAREF) for clinical trials and ethics oversight. Pharmacovigilance (PV); the African Blood Regulators Forum (ABRF); Medicines Policy and Regulatory Reforms (MPRR); Regulatory Capacity Development (RCD) and Good Manufacturing Practice (GMP); Registration and Marketing Authorisation (MA) and Information Management System (IMS). The AMRH partnership Platform provides support to the Technical Committees. African Union Development Agency-New Partnership for Africa’s Development (AUDA-NEPAD) and the World Health Organization (WHO) serve as Joint Secretariat for the AMRH Initiative; together with the African Union Commission.

The African Medicines Regulatory Harmonization Governance Framework

AMRH Steering Committee

Boitumelo Semete-Makokotlela

CHAIR

Dr. Boitumelo Semete-Makokotlela Chair of AMRH Steering Committee, CEO, South African Health Products Regulatory Authority. With a Ph.D. in Biochemistry and an MSc in Management Finance and Investment, Boitumelo has a diverse background. She's been an Executive Director at CSIR Biosciences, managed a biotechnology incubator at The Innovation Hub Management Company, and was a McKinsey Leadership Fellow. Boitumelo is a seasoned professional in the regulatory and scientific advisory spaces.

Adam Mitangu Fimbo

Vice Chair

Mr. Adam Mitangu Fimbo Vice Chair of the AMRH Steering Committee, Director General, Tanzania Medicines and Medical Devices Authority Adam holds a bachelor’s degree in pharmacy, two Master's degrees, and is pursuing a doctorate. Under his leadership, TMDA achieved ISO 9001 certification and WHO Maturity Level 3.

Richard Tendayi RUKWATA

Mr. Richard Tendayi Rukwata Director-General, Medicines Control Authority of Zimbabwe. With 25 years of experience, Richard is a pharmacist and currently heads the Medicines Control Authority of Zimbabwe. He also chairs the Pharmacists Council of Zimbabwe, serves on the Health Professions Authority of Zimbabwe, and co-founded the Pharmaceutical Regulatory Affairs Association of Zimbabwe.

Mrs. Delese Mimi Darko

Dr. Delese Mimi Darko. With a Bachelor of Pharmacy, MBA and PhD, Mrs. Delese Mimi Darko has three decades of experience in regulating food and drugs. She's a driving force behind FDA's recognition as a Regional Center of Regulatory Excellence. Mimi also chairs the WHO African Vaccines Regulatory Forum and the Steering Committee for West African Medicines Regulatory Harmonization.

Doctor Aminata P. NACOULMA

Dr. Aminata P. NACOULMA . A state doctorate in Pharmacy and a PhD in Biomedical and Pharmaceutical Sciences, Dr. Aminata P. NACOULMA is the Director General of the National Agency for Pharmaceutical Regulation in Burkina Faso. She has played a pivotal role in the creation of the agency and its subsequent growth.

Professor Christiana Mojisola Adeyeye

Professor Christiana Mojisola Adeyeye As the Director General of Nigeria's NAFDAC, Professor Adeyeye leads regulatory and administrative reforms. She is the former Chair of the AMRH Steering Committee, and currently chairs the WHO-based Global Pediatric Regulatory Network, and represents NAFDAC on international bodies. She's an expert in research, drug development, and regulatory science, with numerous accolades and a rich academic background.

Dr. David Nahamya

Dr. David Nahamya Secretary to the National Drug Authority of Uganda, Dr. Nahamya is a pharmacist with over 18 years of experience in drug regulation. He holds multiple master's degrees and has played various key roles within the NDA.

Mrs Heran Gerba

Mrs. Heran Gerba. Ms. Heran Gerba is Director General of the Ethiopian Food and Drug Authority. She has a master’s degree in Pharmaceutical Analysis & Quality Assurance and has been dedicated to the authority for many years.

Dr Dalia Abouhussein (Egypt)

Dalia Abouhussein, QA General Manager of the Egyptian Drug Authority since 2021. She holds a PhD in pharmaceutics and diploma in total quality management.

Dalia has been working in the Egyptian national quality control lab for more than 20 years after her graduation from faculty of Pharmacy, Cairo University. She was the Head of Central Administration of EDA Chairman office.

Dalia Abouhussein has 13 peer reviewed published articles in pharmaceutical and regulatory scope.

AMRH Joint Secretariat Members

Nancy Yang-Ngum

Public Health Expert

Nancy Yang-Ngum is a Public Health Expert at the African Union Development Agency (AUDA-NEPAD) working under the African Medicines Regulatory Harmonization (AMRH) initiative. Her primary responsibility is focused on the operationalization of the African Medicines Agency (AMA), by supporting the coordination of the Regional Medicines Regulatory harmonisation programmes and the AMRH Partnership Platform. She is also leading the team of experts in Africa tasked to oversee the development of a Regulatory Information Management System (RIMS) and Regulatory Information Sharing Platform (RISP) for Africa. She is passionate about patient access to safe, quality and efficacious medical products and has embarked on conducting studies to assess the performance of Regulatory Review Systems with a view to improving patients’ access to Medicines in Africa.