Regulatory Authority Evaluation of the Effectiveness and Efficiency of the ZaZiBoNa Collaborative Medicines Registration Initiative: The Way Forward

Abstract

IntroductionZaZiBoNa, the work-sharing initiative in the Southern African Development Community (SADC) that has been in operation for 8 years has successfully assessed over 300 dossiers/applications, with an overall median time to recommendation of 12 months. All 16 SADC countries participate in the initiative as either active or non-active members. While the successes of ZaZiBoNa are evident, some challenges still exist. The aim of this study was to solicit the views of the participating authorities on the effectiveness and efficiency of the current operating model of the ZaZiBoNa initiative.MethodsData were collected in 2021 using the Process, Effectiveness and Efficiency Rating (PEER) questionnaire developed by the authors. The questionnaire was completed by the focal person in each country and approved by the head of the authority.ResultsZaZiBoNa serves as a platform for work sharing, information exchange, capacity building and harmonisation of registration requirements. One of the benefits to regulators has been the improvement in the capacity to conduct assessments. Manufacturers have benefited from compiling one package (modules 2–5) for the initial submission as well as a single response package to the consolidated list of questions, which saves time and resources. Respondents were of the view that patients have benefited as the ZaZiBoNa has contributed to an improved availability and accessibility to quality-assured medicines. Some of the challenges identified were the inadequacy of resources and differences in time to the implementation of ZaZiBoNa recommendations by the individual countries. The establishment of a regional unit hosted in one of the member countries to enable centralised submission and coordination was identified as the best strategy to improve the effectiveness and efficiency of the initiative in the interim, with the long-term goal being the establishment of a regional medicines authority.ConclusionThe study identified the strengths of the ZaZiBoNa initiative as well as the opportunities for improvement. The recommendations made would further strengthen this initiative.

Pharmaceutical Industry Evaluation of the Effectiveness and Efficiency of the ZaZiBoNa Collaborative Medicines Registration Initiative: The Way Forward

“…The removal of country-specific requirements was identified in both this and the regulators study ( 15 ) as one of the best ways to improve effectiveness and efficiency. Authorities in the SADC region now require submission of the dossier in CTD format; however, there are some country-specific requirements identified in this study such as bioequivalence, labelling and local Quality Information Summary and Quality Overall Summary that still impede harmonisation efforts and this is consistent with findings from other studies in the literature ( 15 , 22 ). There is now a need for countries to make a deliberate effort to collectively review their legislation in order to include provisions that facilitate the harmonisation of the registration and labelling requirements for medicinal products in the SADC region.…”

“…The results of this study show that applicants perceive that there has been a high degree of success and benefit from the ZaZiBoNa initiative for applicants, patients and regulators. A similar study was conducted with regulators ( 15 ) and the responses compared. Regulators and industry commonly agreed that information sharing among regulators and harmonisation of registration requirements across the region were the top benefits of the ZaZiBoNa initiative.…”

“…Both regulators and pharmaceutical industry were of the view that the initiative has resulted in greater access to quality-assured medicines by patients, although there was a difference in opinion regarding the time that this is taking. A number of applicants were of the view that ZaZiBoNa resulted in shorter timelines, while only a minority of regulators believed that this was a benefit ( 15 ). Further investigation is required to understand why the initiative is not resulting in reduced prices of medicines for patients, since both regulators and industry acknowledge that time, resources and the effort required to get medicines approved has been reduced.…”

“…While the successes and benefits of the ZaZiBoNa initiative have been examined in this study, it is apparent that there is now a need to review the operating model in order to address the challenges that have been identified to make it more effective and efficient. Views of the regulators ( 15 ) and industry were compared and there was agreement on the challenges such as lack of information for applicants on country websites, failure by applicants to meet deadlines for submission of responses, inadequate resources, an unclear operating model and differing performance by participating regulatory authorities.…”

“…This is supported by studies in the literature highlighting the inadequacy of resources currently available to authorities in low- to middle-income countries ( 16 – 20 ). Challenges highlighted by the industry but not identified in the regulators study ( 15 ) are the difficulties faced by applicants when they need to follow up on pending dossiers/applications or seek arbitration in situations in which individual authorities were uncooperative. The challenges identified in this study are not unique to this initiative, as they have been identified for other regions such as the East African Community, with applicants indicating that the goal of harmonisation, which was to ensure quicker access to quality-assured medicines was not always being met ( 21 ).…”