Third African Medicines Regulatory Harmonisation (AMRH) Week Held In Accra (PICS)

The third African Medicines Regulatory Harmonisation (ARMH) week has been held at the Labadi Beach Hotel, in Accra.

The ARMH seeks to represent an important platform for strengthening regulatory systems on the continent.

Speaking at opening ceremony, Chief Executive Officer (CEO) of the Food and Drugs Authority (FDA) Ghana, Delese Mimi Darko said "The AMRH forms part of the broader African Union Framework on Pharmaceutical Manufacturing Plan for Africa (PMPA). At its core, the goal of the AMRH is to facilitate and coordinate the harmonization of medicines regulation and increase access to quality, safe, efficacious and affordable medicines in Africa. There are numerous reasons why this is crucial but none more glaring than the recent ravages of the COVID-19 pandemic"

Explaining further, Madam Mimi Darko revealed that since tye last AMRH week held in 2020, the conversations on COVID-19 have shifted from addressing the urgent short-term needs to building the long-term resiliency of our continent on pandemic preparedness.

She stressed that it is no surprise that vaccine production is at the centre of this need, culminating in the establishment of the Partnerships for African Vaccine Manufacturing (PAVM).

"PAVM’s laudable continental strategy and framework for action is focused on 8 bold initiatives that have been transposed into annual priorities for action. For this year attention is on regulatory process harmonisation, strengthening National Regulatory Authorities (NRAs) and strengthening the Regional Centres of Regulatory Excellence (RCORE) platform to facilitate vaccine regulatory oversight"

Tauting some remarkable achievements, Madam Darko hinted that the FDA over the past 25 years with support from such strategic partners have attained ISO 9001-2015 certification for its technical and administrative operations and the ISO/IEC 17025-2017 accreditation for 58 tests covering allopathic medicines, medical devices, cosmetics, and food.

"Thus, giving the FDA the highest testing scope under one roof in Africa. As a Regional Centre of Regulatory Excellence, we have trained more than 52 African regulators in clinical trial oversight, pharmacovigilance, and marketing authorization"

"Since 2020 we have been designated as a Maturity Level 3 agency based on the World Health Organization’s Global Benchmarking Tool and we are working assiduously to achieve ML4. In August 2022 the Drugs Physico-chemical Laboratory of the CLSR attained WHO-Prequalification status. These are no mean feats and as we bask in the light of these achievements, we also acknowledge the responsibility this places on us to support other NRAs"

The CEO also disclosed that her outfit has shown its commitment to such a responsibility by training 12 countries in medicines authorisation and registration, seven (7) countries in pharmacovigilance and eleven (11) countries in clinical trial oversight across Africa.

She stressed that the momentum for joint learning and mentorship is rife adding that FDA is keen to grow along with many other NRAs to achieve the audacious vision of a robust medicines regulatory regime in Africa.

"The AMRH has been instrumental in the operationalization of the PAVM and I have no doubt that this same fastidiousness would be extended to the realization of the African Medicines Agency (AMA). Indeed, these are moments in history, and we are privileged to play our parts in laying the foundations for this ambitious task"

"To all partners, we thank you for the commitment demonstrated toward developing a strong medicine regulatory environment. You would agree with me that the vision of a harmonized and robust continental medicines regime is only achievable through collaboration"

Reading a speech on behalf of the Regional Director, WHO, Regional Office for Africa, Dr. Rebecca Matshidiso Moeti, the Representative of WHO, Dr. Elizabeth Juma said "It is a significant milestone in regulatory harmonization, that this AMRH week is being celebrated in Accra, Ghana, because 16 years ago, WHO established the African Vaccines Regulatory Forum (AVAREF) in this same city and country, with the sole purpose of promoting regulatory harmonization and capacity building. AVAREF remains a technical working group supporting clinical trials of vaccines and registration of products in emergencies"

She added that substantial progress has been observed over the past 3 years of the Regulatory capacity of National Regulatory Agencies in the African Region.

She noted that in line with the Regional Framework for Regulation of Medical Products 2016–2025, WHO continued to build technical capacity of regulators through evaluating, sharing best practices and training on WHO guidelines.

"The AMRH being implemented in five RECs has been able to deliver positive results in helping countries in establishing robust legal frameworks, and harmonize regulatory requirements, standards, processes, and capacity-building. Expansion of the scope from generic medicines to new chemical entities, vaccines, and medical devices/IVDs, and the reduction of timelines for granting marketing authorizations are a few to mention"

"Regional economic communities are involved in harmonization initiatives to increase access to good quality, safe and effective medicines through harmonizing medicines regulations, and expediting registration of essential medicines"

She mentioned that WHO has been working with the African Union Commission (AUC) and the Africa Union Development Agency (AUDA)/NEPAD) on the best strategy and modalities to expedite the signing/ratification of the AMA Treaty and its operationalization.

"It has allocated $1 million USD for the AU-WHO joint work plan for the establishment and operationalization of the African Medicines Agency (AMA). The WHO will continue providing technical support in the operationalization of AMA through participation in different fora established under the AMRH program to support AMA operationalization and the secondment of competent technical staff to AUC"

"Despite substantial progress in improving access to good quality safe and efficacious medicines, challenges remain, and countries are at different stages with these challenges. The COVID-19 Pandemic highlighted some gaps in our health systems including our Regulatory systems and taught us some very useful lessons which require us to build resilience into our health systems to deal with the next pandemic when it occurs"

Current Issues in Regulation of Health Products on the Continent

She said "In July 2022, Gambia saw an increased number of children dying from Acute Kidney Injury (AKI). Following investigations, Di-Ethylene glycol (DEG) was found in 4 different paediatric syrups. One would ask what went wrong with the regulatory process which resulted in the introduction of these toxic substances on the market in the Gambia"

She hinted that it is important to invest in the regulatory process to safeguard public health and save lives.

"For instance, 72,000 to 169,000 deaths are caused by substandard and falsified antibiotics in children under 5 suffering from pneumonia. Similarly, 31,000 to 116,000 deaths are caused by substandard and falsified antimalarials in sub-Saharan Africa with an estimated US$38.5million annual spending on these products"

Vulnerability of the health product value chain in Africa

She explained that Africa is 70% dependent on imported pharmaceuticals.

She added that to reduce dependence on imported medical products, African leaders expressed their will to boost local manufacturing capacity.

"The 74th World Health Assembly resolution on Strengthening Local Production of Medicines and Other Health Technologies to Improve Access urges Member States to engage in North–South and South–South development cooperation, partnerships and networks to build and improve the transfer of technology. The resolution was co-sponsored by more than 100 Member States, including all the African countries."

Progress to date

"All countries in WHO African region currently have NRAs (or at least an administrative unit performing some or all the functions of an NRA) but their organizational set-up and functionality is variable. Countries should view the establishment of the AMA (African Medicines Agency) as an opportunity to improve NRAs’ capacity in Africa"

"To date five African National Regulatory Authorities - Egypt, Ghana, Nigeria, South Africa and Tanzania operate at Maturity Level (ML) 3 commensurate with stable, wellfunctioning and integrated regulatory systems. Both Egypt and South Africa perform at maturity level 3 for vaccines regulation and are vaccines manufacturers. The NRAs with strong capacities and operating at ML 3 will be instrumental for the continental regulatory functions to be performed by AMA"

Call to action

Touching on the call to action, she said "There is need to invest in regulatory systems strengthening for effective AMA and in ensuring supply and access to safe, effective, and quality assured medical products. Harmonization initiatives need to relook and rethink the harmonization process and need to develop innovative ways to promote harmonization in Africa"

"Strengthening of the AMRH partnership platform (the WHO Coalition of Interested Parties Regional Steering Group) and ensuring fair distribution of partners’ support to NRAs and REC’s MRH initiatives.

Representing the Minister of Health, Dr. Kwaku Agyeman Manu, the Special Advisor to Minister of Health on Human resource, Dr. Baffour Awuah said "Natural Regulatory Authorities (NRAs) plays a critical role in ensuring access to quality assured products such as vaccines, when need expedited development, manufacture, and deployment especially in the event of a public health crisis"

He added that many African governments have realised and agree that there is an urgent need to strengthen manufacturing capacities on the continent for vaccines and other medical products.

Story by: Joshua Kwabena Smith