The Intergovernmental Authority on Development (IGAD) member states are set to develop a common regulatory framework for locally manufactured medicines.
IGAD aims to enhance ts members states competitiveness in the pharmaceutical industry and provide high-quality health products.
This came as a regional workshop kicked off on Monday in Addis Ababa, the capital of Ethiopia, where health experts, medicines manufacturers from eastern and southern Africa and representatives of the World Health Organization (WHO), dwelling on White Paper on Bioequivalence (BE) Testing Capacity and Harmonization of Bioavailability and Bioequivalence (BA/BE) Regulatory Requirements.
Speaking at the event, Girum Hailu, senior policy and partnership specialist at IGAD, said the White Paper will help provide an evidence-based strategic framework for strengthening regional BA/BE infrastructure, harmonise regulatory requirements, mobilise investments, and support sustainable local pharmaceutical products.
“Access to quality-assured, safe and effective medicines depend not only on manufacturing capacity, but also on scientific evidence that medicines perform as expected and deliver the intended treatment outcomes,” Hailu said.
He said a strong BA/BE ecosystem is critical to protect patients, build confidence in locally manufactured medicines, support regulatory decision-making and build a more predictable environment for medicine manufacturers in the region.
While opening the workshop, Afework Kassa, director general of Armauer Hansen Research Institute (AHRI), recalled that IGDA member states largely depend on external bioequivalence testing that has resulted in huge economic burden and delayed approval of locally manufactured generic medicines.
He said the move to develop a common regulatory framework for locally manufactured medicines will help build qualified bioequivalent centres, competent pharmaceutical manufacturers, universities and research institutions.
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.
According to the study, many manufacturers depend on studies conducted outside the region, often at very high cost and with longer product development and registration timelines.
According to a concept note dispatched at the workshop, despite increasing investment in pharmaceutical manufacturing across Eastern and Southern Africa, the region continues to face significant challenges in meeting Bioavailability/Bioequivalence (BA/BE) regulatory requirements.
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.
IGAD comprises seven member states namely Djibouti, Ethiopia, Kenya, Somalia, South Sudan, Sudan and Uganda.
MG/as/APA