As part of the Optimising Efficiencies in Regulatory Agencies (OpERA) programme, CIRS has been working closely with the regulatory agencies who are active in ZaZiBoNa, the Southern African Development Community (SADC) collaborative medicines registration initiative, to evaluate the efficiency and effectiveness of the current operating model of ZaZiBoNa. In parallel, a study gathering views of the pharmaceutical industry was carried out. These two studies have been published in the same issue of Frontiers in Medicine, and represent the first time ZaZiBoNa has been evaluated in such a way by both regulators and industry.
All nine of the ZaZiBoNa agencies (Botswana, Democratic Republic of Congo, Malawi, Mozambique, Namibia, South Africa, Tanzania, Zambia and Zimbabwe) participated in the first study. The agencies agreed that the ZaZiBoNa initiative has facilitated greater information sharing and harmonisation of registration requirements, ultimately contributing to improved availability and accessibility to quality-assured medicines. Recommendations to improve the effectiveness and efficiency of ZaZiBoNa were also identified, including better measuring and monitoring regulatory timelines, capacity building and establishment of a SADC regional medicines authority.
19 pharmaceutical companies participated in the second study, which showed consensus with the agency views of the first study. In addition to facilitating greater information sharing and harmonisation of registration requirements, the ZaZiBoNa initiative was reported to save industry time and resources. Recommendations for improvement identified from the industry point of view included enhancing submission procedures, automating information management systems and promoting reliance pathways.
The two papers can be downloaded via the links below:
The OpERA programme is open to all regulatory agencies, regardless of size or maturity; please don’t hesitate to get in touch with Professor Stuart Walker (firstname.lastname@example.org) if you would like to find out more about the programme or about these two particular studies.