Zbabina Collaborative Case Study Solution

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Results The case: ZAZIBONA collaborative model is practically oriented and focused on achieving results in terms of accelerated approvals for applications for registration while enhancing the quality of approved products. The vision of this initiative is (a) a region in which good-quality medicines are available to all those who need them; (b) significantly reduced time taken to grant marketing authorisation in the individual countries; and (c) efficient utilisation of resources within regional national regulation through work sharing. The specific objectives are to (i) reduce regulatory workload, (ii) accelerate registrations of selected products, (iii) develop mutual confidence in regulatory collaboration, (iv) demonstrate a mechanism of technical…show more content…
Special consideration may be given to medicines that are vital to effective treatment and to expanding national treatment programmes, where there are currently limited options for health practitioners in the participating countries. This includes medicines identified for special regional programmes and initiatives. Priority is given to treatments for the 10 priority diseases conditions identified by SADC, which are HIV and AIDS, tuberculosis, malaria, acute respiratory infections, diarrhea, diabetes, pneumonia, cardiovascular, cancer, and gastroenteritis and colic. Products for obstetrics and reproductive health are also included on this list as well as those products included in the List of the United Nations (UN) Commission for Live-Saving Commodities for Women and Children.24 Any other medicines that are important from a public health perspective may be considered on a case-by-case basis. Products registered by stringent regulatory authorities (SRA) are eligible for an abridged review process provided there is access to the assessment reports for which the authorisation was based

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