ZAZIBONA

ZAZIBONA is a collaborative medicines registration initiative in Southern Africa focusing on dossier assessments and good manufacturing practice (cGMP) inspections. It was founded in October 2013 by four countries Zambia, Zimbabwe, Botswana and Namibia with the support of WHO prequalification and the Southern Africa Regional Program on Access to Medicines (SARPAM). The name ZAZIBONA is a combination of the first two letters of the name of the founding countries and coincidentally means ‘to look to the future’ in a local Zambian language, nyanja. The name ZAZIBONA has been retained even though the membership has grown from the four founding countries to all 16 SADC countries. The initiative was formally endorsed by the SADC Ministers of Health in 2014 and became part of the SADC medicines registration harmonisation (MRH) project in 2015.

The Southern African Development Community (SADC) collaborative medicines registration initiative, ZaZiBoNa is a successful regional work-sharing initiative on the African continent. The ZaZiBoNa medicines collaborative registration initiative was established in 2013 by four countries, Zambia, Zimbabwe, Botswana, and Namibia, with technical support from the WHO Prequalification Team (PQT). The acronym ZaZiBoNa was derived from the first two letters of the founding countries, and also has a special meaning in Nyanja, one of the local Zambian languages which means “look to the future.” The initiative was formed to address common challenges faced by the participating countries such as huge backlogs of product applications, high staff turnover, long registration times, inadequate financial resources, and limited capacity to assess certain types of products such as biologicals and biosimilars. Acknowledging these common challenges, the Heads of Agencies of National Medicines Regulatory Authorities agreed to develop a work-sharing arrangement to meet the objectives that included a reduced workload, reduction in timelines to registration, the development of mutual trust and confidence in regulatory collaboration, and to provide a platform for training and collaboration in other regulatory fields.

Today nine SADC countries, Botswana, Democratic Republic of Congo Namibia, Malawi, Mozambique, South Africa, Tanzania, Zambia and Zimbabwe participate in the ZaZiBoNa work-sharing initiative as active members whilst Angola, Seychelles, Swaziland, and Madagascar participate in ZaZiBoNa as non-active members and Comoros Islands, Lesotho, and Mauritius are the few remaining countries not yet participating in the initiative.