The regional legislation, the EAC Pharmaceuticals Bill, championed at the East African Legislative Assembly (EALA) by Rwandan legislator Francine Rutazana, builds on years of technical work under the EAC Medicines Regulatory Harmonization (EAC-MRH) initiative. The proposed Act is designed to elevate non-binding regional guidelines into a legally binding framework governing essential human medicines, vaccines, and medical products across all eight EAC Partner States.
National stakeholder consultations were held across the member states from August 17 to 21, 2026, to refine key provisions ahead of the Bill’s remaining legislative stages at EALA and its eventual submission to the EAC Summit of Heads of State for assent.
In each Partner State, stakeholders across the healthcare supply chain, including pharmaceutical manufacturers, public health policymakers, National Medicines Regulatory Authorities (NMRAs), academic institutions, traders, and industry players, met to identify provisions needed in the final text.
The consolidated country recommendations will be submitted to EALA for harmonization before the Bill undergoes formal readings.
The legislative push reinforces long-running EALA efforts to harmonize pharmaceutical regulation, improve market surveillance, and promote locally manufactured medical products within the Community. Rutazana previously introduced private member legislative motions aimed at encouraging regional manufacturing, enforcing Good Manufacturing Practice (GMP) standards, and establishing mutual recognition procedures for medicine registrations.
Speaking following consultations held in Rwanda from August 20 to 21, 2026, Rutazana noted that transitioning existing guidelines into statutory law will streamline operations among regulatory authorities across the region.
She cited National Medicines Regulatory Authorities as a primary example, noting that such institutions currently operate at varying levels of development across the bloc. While countries like Rwanda, Kenya, Uganda, and Tanzania have established national food and drug authorities, other Partner States are operating with developing frameworks or legacy systems.
Rutazana emphasized that these structural discrepancies make joint safety assessments and cross-border market surveillance difficult without a binding regional legal instrument.
The EAC Pharmaceuticals Bill also establishes unified requirements for local and international pharmaceutical manufacturers operating within the Community.
“Pharmaceutical manufacturers need a clear statutory framework to collaborate effectively, as variations in product quality standards impede cross-border trade,” she said.
“Harmonizing quality and safety compliance ensures that if a manufacturing facility operating in one Partner State is inspected and authorized, its products can trade across the bloc without facing redundant, country-by-country inspections.”
Rutazana added that a binding regional framework will expand the market footprint for EAC-produced essential medicines, allowing regional health systems to source quality-assured products locally rather than depending heavily on external imports.
Under EALA’s legislative roadmap, the Bill is expected to complete its parliamentary stages by December 2026 before being presented to the EAC Summit of Heads of State in 2027 for final assent into law.
Mwesigye John Patrick, Director of the EAC Regional Centre of Excellence for Vaccines, Immunization and Health Supply Chain Management (EAC RCE-VIHSCM), told IGIHE that the Bill addresses long-standing enforcement gaps in regional health cooperation.
He explained that while the EAC has developed technical guidelines over the past decade, their non-binding nature creates legal uncertainty during supply chain disputes or enforcement actions.
“This law will provide statutory authority to existing regulatory frameworks. While technical guidelines remain operational, the law will take precedence in any legal or cross-border dispute,” Mwesigye said.
“Previously, there was no comprehensive regional law specifically protecting buyers, suppliers, or public health authorities in cases involving substandard or falsified medicines.”
Under the proposed statute, a standardized Mutual Recognition Procedure (MRP) and unified market authorization system will govern all human medicines entering EAC markets, whether produced locally or imported from outside the region.
The framework is structured to streamline trade barriers for compliant local manufacturers while maintaining rigorous oversight.
“Regulators in our respective Partner States will continue performing GMP inspections at manufacturing facilities to ensure strict adherence to safety and quality standards,” Mwesigye said.
“Once authorized, national procurement agencies, such as Rwanda Medical Supply, can integrate these approved products into their supply networks, allowing seamless distribution across borders without unnecessary administrative hurdles.”
The framework will also empower NMRAs to execute joint, region-wide product recalls whenever a safety or quality defect is identified in a pharmaceutical batch.
119 operational pharmaceutical facilities across the EAC
According to data cited by Mwesigye, the EAC currently hosts 119 licensed human pharmaceutical manufacturing facilities.
Kenya accounts for 30 plants, followed by Uganda (38), the Democratic Republic of the Congo (34), Tanzania (15), Rwanda (7), Burundi (2), and Somalia (1). South Sudan currently has no operational pharmaceutical manufacturing plant.
Together, these facilities satisfy approximately 30% of the human pharmaceutical demand within the EAC, though local production capacity varies widely between Partner States, falling below 1% in some countries. An estimated 50 additional pharmaceutical production plants are currently under development across the bloc.
Mwesigye cautioned that the 30% regional production figure does not equate to complete product coverage. A single manufacturing facility may produce only 20 active formulations, whereas national healthcare systems often require up to 4,000 distinct pharmaceutical lines, leaving the bloc reliant on external imports for 70% of its medical needs.
“The progressive establishment of new facilities has been encouraged by the regulatory guidelines developed under the EAC-MRH initiative over the years,” Mwesigye said. “Enacting a full regional law will provide the long-term regulatory certainty needed to attract large-scale industrial investment.”
The legislative timeline aligns with the African Union’s continent-wide mandate under the Partnerships for African Vaccine Manufacturing (PAVM), which targets 60% self-sufficiency in African vaccine production by 2040, up from less than 1%. Harmonized regulatory frameworks and regional procurement preferences are seen as vital foundations for achieving that target.
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