Member states of the Intergovernmental Authority on Development (IGAD) have agreed to advance common principles and requirements for locally manufactured medicines.
Following a five-day deliberation on what are called “Bioavailability and Bioequivalence” regulatory requirements in Addis Ababa, Ethiopia’s capital, the member states agreed to develop a common regulatory framework aligned with relevant World Health Organization (WHO) guidance and other internationally acceptable guidelines as well as standards set by the Africa Medicines Agency (AMA).
In a resolution released last weekend, representatives of IGAD member states and Southern African countries underscored the significance of the regulatory framework to manufacture high-standard medicinal products that protect patient safety and minimize the risk of medicine supply disruptions.
They underscored that the introduction of a regional BE testing facility that will help strengthen national facilities, reinforce good clinical and laboratory practices and explore a coordinated mechanism to reduce the cost of BA/BE studies and improve access to testing services, particularly for priority locally manufactured products.
The resolution also noted the need to translate the draft White Paper into country-level roadmaps with clear responsibilities, investment priorities, timelines and measurable results.
The White Paper, which will undergo further review, will serve as guide to harmonize bioavailability and bioequivalence (BA/BE) regulatory requirements and strengthen regional capacity for testing locally manufactured medicines across Eastern and Southern Africa.
The initiative is part of IGAD’s broader efforts to strengthen regional pharmaceutical manufacturing and regulatory harmonisation and agreed to advance common principles and requirements for locally manufactured medicines.
A study conducted by IGAD in 2024 revealed that countries are at different stages of developing and implementing bioequivalence requirements, while the regional capacity for bioequivalence testing, specialized expertise and regulatory oversight remain limited.
The limited number of internationally accredited BA/BE centers within Africa, coupled with fragmented regulatory requirements across National Regulatory Authorities (NRAs), creates uncertainty for manufacturers and discourages investment in product development, according to the concept note dispatched at the workshop.
IGAD comprises seven member states namely Djibouti, Ethiopia, Kenya, Somalia, South Sudan, Sudan and Uganda.
MG/as/APA