Africa has taken a significant step toward improving healthcare access by approving five human medicinal products through a new continental regulatory process, marking the first-ever coordinated medicine approvals at the pan-African level.
The African Medicines Regulatory Harmonisation (AMRH) Initiative, operating under the African Union Development Agency (AUDA-NEPAD), announced this breakthrough during a recent virtual press conference. The initiative aims to address the continent's historically fragmented regulatory landscape that has delayed access to essential treatments and created opportunities for counterfeit medications to proliferate.
"This is an important milestone for the continent," said Chimwemwe Chamdimba, Head of the AMRH Programme. "It's the first-ever listing of human medicinal products at the continental level."
Approved Products and Evaluation Process
The five products that received approval through this landmark process include:
- Easy Six Vaccine: A combination vaccine for children
- Gardasil 9 (in both Prefilled Syringe and Vial formats): Vaccines to prevent HPV infections
- Bavencio: A treatment for certain types of cancer
- Keytruda: An advanced cancer medicine
The pilot approval process began in November 2023 and involved rigorous scientific evaluation by two technical committees: the Evaluation of Medicinal Products (EMP-TC) and the Good Manufacturing Practice (GMP-TC). These committees reviewed manufacturer dossiers, conducted scientific assessments, and inspected production facilities to ensure compliance with international standards.
Aude Perine Minyem Ngombi, Chair of the EMP-TC, emphasized the thoroughness of the evaluation process: "Each product underwent comprehensive scientific review to ensure safety, efficacy, and quality before receiving approval."
The Green Book: Enhancing Transparency
A key component of this new regulatory system is the "Green Book," a digital registry that documents all medicines approved at the continental level. This publicly accessible online resource includes essential information such as product names, compositions, approval dates, and listing expiration dates.
"The Green Book is a way to promote transparency," explained Ngombi. "It helps the public and stakeholders know what products have been approved and how they were evaluated."
In addition to the Green Book, the AMRH has published inspection and assessment reports detailing the decision-making process for each approved product. This unprecedented level of transparency aims to build trust among stakeholders and encourage broader participation from African nations.
Paving the Way for the African Medicines Agency
This continental listing process serves as a precursor to the establishment of the African Medicines Agency (AMA), a specialized African Union body created to oversee medicine regulation across the continent. The AMRH initiative is effectively testing systems and processes that will eventually be adopted by the AMA.
"This pilot paves the way for the African Medicines Agency's work," noted Chamdimba. "It sets up the systems and processes that AMA will pick up and run with."
Once fully operational, the AMA will support national regulatory authorities and help member states approve complex medical products using standardized scientific methods. The agency aims to foster mutual trust, shared responsibility, and more predictable market access across Africa.
Economic and Health Benefits
Health experts across Africa have highlighted the potential economic and health benefits of this harmonized approach to medicine regulation.
John Paul Omollo Odhiambo, a Global Health Specialist based in Kenya, described the development as "a monumental achievement" that "guarantees improved health outcomes and allows individuals to return to their productive lives sooner."
The harmonized system is expected to reduce costs for pharmaceutical companies by eliminating duplicative regulatory processes, potentially leading to lower medicine prices. Additionally, the strengthened regulatory framework will help combat substandard and falsified medicines, a significant public health threat across the continent.
"By reinforcing regulatory harmonization, we can ensure the availability of high-quality medicines, inspire innovation, and fortify our fight against fake drugs," Odhiambo explained. He added that the process would likely attract investment into Africa's growing pharmaceutical sector, creating jobs and promoting local manufacturing.
Implications for Individual Countries
For countries like Cameroon, which has struggled with delays in drug approvals and counterfeit medications, the new listing process offers tangible benefits.
Dr. Cynthia Ada Nge, a Cameroonian Public Health Expert, noted: "Cameroon has faced delays in drug approvals and struggles with fake medicines. This new system offers faster access to safe treatments."
According to Dr. Ada, Cameroon can now leverage the AU-approved medicines list to expedite market access for treatments. The country's drug testing laboratory, LANACOME, will also benefit from alignment with the African Medicines Agency's standards.
"Cameroon can now trace and verify drugs more easily using digital tools like QR codes," she added. "This will make it harder for fake medicines to circulate."
Next Steps for Implementation
For this continental listing system to fully benefit patients, experts recommend several critical actions for African governments:
- Adopt reliance principles that allow regulators to trust one another's decisions
- Align legal frameworks with African Union guidelines
- Invest in training regulatory staff to handle technical evaluations
- Promote mutual trust through joint reviews and information sharing
- Standardize evaluation procedures to improve consistency
Dr. Ada suggested that countries like Cameroon should integrate the AU medicines list into their national drug registries and educate the public on identifying safe medicines.
A Vision for Africa's Healthcare Future
This first continental approval of human medicinal products represents more than just a regulatory achievement—it signals a strategic move toward equity, transparency, and innovation in African healthcare.
"This is about building the Africa we want," Chamdimba emphasized. "We are driving economic growth and improving public health for our population."
As this regulatory framework continues to develop, patients across Africa can anticipate safer and faster access to essential medicines, potentially transforming healthcare delivery across the continent.
