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

Abstract

IntroductionThe common technical document (CTD) format harmonised the requirements for the registration of medicines, which had traditionally differed from country to country, making it possible for countries to collaborate and conduct joint reviews of applications. One such collaborative medicines registration initiative is the Southern African Development Community ZaZiBoNa, established in 2013. A recent study was carried out with the nine active member regulatory authorities of the ZaZiBoNa to determine their views on its operational effectiveness and efficiency. Having obtained the authorities’ views, the aim of this study was to evaluate the effectiveness and efficiency of the current operating model of the ZaZiBoNa initiative including the challenges it faces as well as identifying opportunities for improvement from the applicants’ perspective.MethodsApplicants who had submitted registration/marketing authorisation applications for assessment under the ZaZiBoNa initiative during 2017–2021 were recruited into the study. Data was collected in 2021 using the Process, Effectiveness and Efficiency rating questionnaire (PEER-IND) developed by the authors. The questionnaire was completed by a representative responsible for ZaZiBoNa submissions in each company.ResultsThe pharmaceutical industry was of the view that the ZaZiBoNa initiative has achieved shorter timelines for approval of medicines, resulting in increased availability of quality-assured medicines for patients in the SADC region. Harmonisation of registration requirements and joint reviews have reduced the workload for both the pharmaceutical industry and the regulatory authorities. Some of the challenges identified were the lack of a centralised submission and tracking system, and the lack of information for applicants on the process for submission of ZaZiBoNa dossiers/applications in the individual countries, including contact details of the focal person. The establishment of a regional unit hosted in one of the member countries to centrally receive and track ZaZiBoNa dossiers/applications was identified as the best strategy for moving forward in the interim with the long-term goal being the establishment of a regional medicines authority.ConclusionThere was consensus between the pharmaceutical industry and the regulatory authorities as to the way forward to improve the effectiveness and efficiency of the ZaZiBoNa initiative. Implementation of the recommendations identified in this study will lead to enhanced regulatory performance.

Assessment of the effectiveness and efficiency of the economic community of West African States Medicines Regulatory Harmonization initiative by the pharmaceutical industry

“…Some of the challenges of the ECOWAS-MRH initiative namely, lack of centralised submission and tracking which were identified by the applicants in the study were also identified by the NMRAs in the previous study ( Owusu-Asante et al, 2022 ). Similar to the studies conducted with regard to the EAC-MRH and ZaZiBoNa ( Ngum et al, 2022 ; Sithole et al, 2022 ), these challenges were also reported with regard to the respective regional MRH initiatives. In addition, the applicants in this study identified other challenges that were specific to the ECOWAS-MRH initiative such as differences in regulatory performance of the countries and dependence on the countries’ process for communication with applicants, and lack of detailed information on the process for applicants.…”

“…Data for the study were obtained through completion of the Process Effectiveness and Efficiency Rating (PEER) questionnaire ( Ngum et al, 2022 ; Sithole et al, 2022 ) by applicants between October 2022 and January 2023.…”

“…About a decade ago, Narsai and colleagues reported that there was inadequate information in the literature detailing the views of pharmaceutical manufacturers about the regulatory systems in Africa ( Narsai et al, 2012 ). This situation has now seen some improvement, following studies published in 2022 by Sithole and colleagues with reference to the ZaZiBona initiative ( Sithole et al, 2022 ) and also by Ngum and colleagues regarding the East African Community initiative ( Ngum et al, 2022 ). More studies should therefore be conducted and published so that much-needed data become available to all stakeholders.…”

Evaluation of the effectiveness and efficiency of the East African community joint assessment procedure by pharmaceutical companies: Opportunities for improvement

“…The aim of the CTD guidelines is “to provide harmonised medicines registration procedures using the CTD in order to improve access to essential medicines for prevention and treatment of priority disease conditions in the East African region” ( EAC Secretariat, 2014 ). According to Sithole et al (2022) , the CTD format has helped to improve work sharing and the harmonisation of registration requirements and joint reviews in Africa.…”

Best practices in the African Medicines Regulatory Harmonization initiative: Perspectives of regulators and medicines manufacturers

“…The AMRH initiative's goal was for NRAs within each of Africa's regional economic communities (RECs) to address this problem by coordinating their activities, relying on the work of one another and other trusted regulatory authorities, and applying other principles of smart regulation [5]. Specifically, NRAs within an REC would harmonize technical requirements and standards for medical products regulation, perform joint reviews of marketing authorization applications and joint inspections of manufacturing sites, and increase the use of reliance and cooperation in regulatory matters related to medical products [3,[6][7][8][9]. The resulting improvements in regulatory efficiency would make it easier and faster for medicines manufacturers to register quality products [3,10].…”