The ZAZIBONA process is a collaboration between national medicines regulatory authorities (NMRAs) in Botswana, Namibia, Zambia, and Zimbabwe.
These are four neighbouring countries in Southern Africa which have a combined population of around 34 million. This process may be extended to include participation by other interested SADC Member States.
The vision of the ZAZIBONA process is:
The process objective is to promote a collaboration model to facilitate access to good-quality medicines through worksharing in assessment of medicines and inspection of medicine manufacturing and testing facilities. Products that meet assessment criteria are then granted registration in the participating countries, in which CTD-format applications for registration would have been submitted. Where countries agree that is necessary, variations to the products which have been registered under this collaboration may be handled through the same process.
The ZAZIBONA collaboration does not represent the replacement of the need to submit applications for registration in participating countries in line with national requirements. However, as described in this document, in order to facilitate cooperation among ZAZIBONA authorities, certain modifications are expected. Although there is close collaboration on assessments and inspections, final national registration decisions are the responsibility of individual participating authorities.
It is envisaged that manufacturers of needed medicines will benefit from accelerated registration processes, a single set of questions during the registration process and in principle harmonized registration decisions, which will facilitate easier review of any post-registration variations. Applications may be submitted by any person that qualifies to be an applicant in each participating country as per national requirements.
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