Background Medicines regulatory authorities in the SADC region have limited regulatory capacity in terms of financial and human resources, and information management systems, which limit access of the public to quality assured medicines. Harmonization of medicines regulatory requirements and work sharing is a strategy to improve access to quality assured, safe and efficacious medicines. Collaboration and information sharing among countries with similar evaluation and registration processes on medicines registration can accelerate access to quality assured medicines by reducing the registration timelines for pending applications, facilitate information sharing through trust and mutual confidence building, and ultimately facilitate harmonization of requirements and systems among these countries.

SADC is a REC of the African continent consisting of 16 countries, Angola, Botswana, Comoros Islands, Democratic Republic of Congo, Lesotho, Madagascar, Malawi, Mauritius, Mozambique, Namibia, Seychelles, South Africa, Swaziland, United Republic of Tanzania, Zambia, and Zimbabwe.

The ZaZiBoNa collaborative medicines registration initiative was established in 2013 by four countries, Zambia, Zimbabwe, Botswana, and Namibia, with technical support from the WHO Prequalification Team (PQT) [16–18]. The acronym ZaZiBoNa was derived from the first two letters of the founding countries, and although the initiative has expanded beyond these four countries, the name ZaZiBoNa has been maintained because of its special meaning in Nyanja, one of the local Zambian languages: “look to the future” [2]. 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 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

Legal Position of ZaZiBoNa. The ZaZiBoNa initiative is not a legally constituted regulatory initiative and does not make decisions on the registration or rejection of products [18] but rather operates in an advisory capacity and provides scientific opinions on the quality, safety, and efficacy of products. Participation is based on the signing of a memorandum of agreement entitled “the NMRA Agreement to Participate” by interested countries. However, a condition for active member status is the availability of legislation enabling or mandating registration in the participating country, registration guidelines equivalent to the SADC Medicines Registration guidelines or WHO guidelines, and in-house capacity to conduct assessments and good manufacturing practices (GMP) inspections

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