The ZaZiBoNa initiative to harmonise the regional registration of requirements for pharmaceutical products has saved time and costs for manufacturers and applicants in the SADC region.
The initiative offers lessons for collaboration initiatives in Africa – like the African Medicines Agency – a study has found, but added that the pace of implementing initiatives was disappointing, and that some goals can only be achieved in the medium to long term.
Generally, however, the initiative is meeting most of its objectives, said the researchers.
The study evaluated ZaZiBoNa at its five-year mark to establish a business case for further investment, and the findings were published online in the Journal of Pharmaceutical Policy & Practice.
For more than a decade, ZaZiBoNa has helped Southern Africa Development Community (SADC) Member States protect their populations, assuring the availability and accessibility of good quality, safe and effective medicines.
It serves as a platform for work sharing, information exchange, capacity building and harmonisation of registration requirements, and was formally endorsed by the SADC Ministers of Health in 2014. It became part of the SADC medicines registration harmonisation (MRH) project in 2015.
The initiative involves joint assessments and joint inspections of pharmaceutical products for registration under the umbrella of the SADC Medical Products Harmonisation initiative.
Through ZaZiBoNa, the harmonisation of registration requirements for pharmaceutical products has made it easier and less time-consuming for manufacturers and applicants to compile a single submission for all nine SADC member states who are active members of the initiative.
The initiative has reduced workload for regulators, built their capacity and reduced timelines for registration of medicines.
Since inception, it has convened 44 joint assessment sessions and assessed more than 350 products – the highest number of products assessed by any regional harmonisation initiative on the African continent.
More than 150 National Medicines Regulatory Authorities (NMRA) staff comprising assessors, inspectors, Quality Management Systems (QMS) auditors and laboratory managers have been trained through the initiative. Furthermore, pharmaceutical regulatory authorities have reported that participating in the initiative has increased their capacity to conduct assessments and good manufacturing practice inspections.
Medicine regulatory harmonisation, or the alignment or integration of technical requirements to facilitate efficiencies for the regulation of the development and marketing of pharmaceuticals, is not a new phenomenon.
However, the scope and level of implementation can differ.
The study looked at the operating model for work sharing implemented by SADC, and its impact related to the number of recommendations for approval made in the initial five years that have been translated into product registrations by member states.
It is the first study to evaluate the follow-through on ZaZiBoNa recommendations and the resultant timelines, and also looked at the related cost to achieve this, and industry experience with utilising the initiative.
Study details
Evaluation of the implementation and the associated operating costs of a medicine regulatory harmonisation model in Africa: the case of ZaZiBoNa, a SADC work-sharing initiative
S. Dube-Mwedzi and F. Suleman.
Published by Taylor & Francis on 25 April 2025
Abstract
Background
To improve the access to and affordability of medicines, countries in the Southern African Development Community (SADC) established ZaZiBoNa, a medicine regulatory harmonisation initiative. Studies have evaluated the initiative's technical and operational efficiencies and effectiveness. This study evaluated ZaZiBoNa from project implementation and cost perspectives, at the 5-year mark, to establish a business case for further investment.
Methods
A quantitative and desk review were undertaken. Two surveys, one with seven National Regulatory Authorities (NRAs) that participated in the initiative in the initial five years were conducted and the other with 40 pharmaceutical companies who submitted applications in the same period were recruited to share their perceived experiences and expectations with the collaborative initiative.
Results
All seven NRAs agreed the initiative had generally achieved its objectives and participation was beneficiary. As of June 2022, the 7 NRAs had registered 152 of the 235 (64.7%) products assessed during the study period, with a median time from joint assessment recommendations to registration of five months, against a target of 3 months (range: four to 14 months). Of the industry respondents (n = 13), 61.5% indicated the initiative had had a positive impact on their business, though expectations were only met to some degree (31%–46%). Failure to create a less expensive process and to facilitate simultaneous multiple market access (31% and 23% respectively) were the most common unmet expectations. Nonetheless, 62% of the industry respondents expressed willingness to continue utilising the collaborative process.
The cost per joint assessment recommendation during the study period was US$2 768.
Conclusion
The study also highlighted that implementation of initiatives could take time and that some goals can only be achieved in the medium to long term. This is a lesson for other collaboration initiatives in Africa, such as the African Medicines Agency.
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