BloodTrain Chapter III

Context

National health systems in sub-Saharan Africa lack sufficient and stable structures to regulate the sustainable supply of blood and blood products. Moreover, the availability of these products remains severely limited. These shortcomings pose significant health risks and contribute, among other factors, to high maternal and child mortality rates, whose reduction is one of the UN’s sustainable development goals (SDGs). The aim of the BloodTrain Chapter III project is to improve the quality, safety, and efficacy of blood products in African project countries by establishing harmonised regulatory structures, thereby contributing to better care for the population. Based on the results of a benchmarking exercise, BloodTrain Chapter III develops together with the medicines regulatory authorities a work plan that addresses gaps in their respective regulatory systems. The project develops and revises regulatory requirements for this purpose, implements them and supports the process through workshops on regulatory topics. BloodTrain Chapter III also promotes the harmonisation of regulatory systems throughout the region in cooperation with continental and international organisations. In its work, BloodTrain draws on seven years of experience and accesses a wide network of experts, including the WHO, WHO AFRO, the International Society of Blood Transfusion (ISBT) and the Africa Society of Blood Transfusion (AfSBT).

Objective

Improved safety and quality of blood and blood products in African countries through strengthened and harmonised regulation

In Cooperation with

• South African Health Products Regulatory Authority, Pretoria, South Africa
• Ministry of Health and Social Services, Namibia Medicines Regulatory Council, Windhoek, Namibia
• Uganda National Drug Authority, Kampala, Uganda
• Food and Drugs Authority Ghana, Accra, Ghana
• Tanzania Medicines and Medical Devices Authority, Dodoma, Tanzania
• Zambia Medicines Regulatory Authority, Lusaka, Zambia
• Medicines Control Authority of Zimbabwe, Harare, Zimbabwe
• AUDA-NEPAD, Midrand, South Africa
• Africa Society for Blood Transfusion, Johannesburg, South Africa
• WHO AFRO, Brazzaville, Congo
• WHO Headquarters, Geneva, Switzerland