Thursday, 18 August 2022

Frequently Asked Question

10. What is ZAZIBONA and how can we participate?

ZAZIBONA is a collaborative procedure for 14 Southern African Development Community (SADC) countries in which national regulatory authorities jointly assess medicines for registration purposes. Currently there are five of the 14 member states actively participating countries which are Zambia, Zimbabwe, Botswana, Namibia and South Africa. The remaining nine of 14 member states do not actively participate in dossier assessment but are involved in training programmes and information sharing on products approved the collaborative procedure. In the long term all SADC countries are expected to actively participate depending on their capacity.

There is mutual agreement and consent is given by applicants for sharing information concerning products being considered. When a product has been approved by ZAZIBONA, it means that the product has attained marketing authorisation in all the participating countries. Applicants who wish to participate in ZAZIBONA should have applied for registration of a medicine in at least two of the participating countries and they should submit an expression of interest to any of the countries to which the application has been made.