Evaluation of the Review Models and Approval Timelines of Countries Participating in the Southern African Development Community: Alignment and Strategies for Moving Forward

Abstract

Introduction: Regulatory reliance, harmonization and work sharing have grown over the last few years, resulting in greater sharing of work and information among regulators, enabling efficient use of limited resources and preventing duplication of work. Various initiatives on the African continent include ZaZiBoNa, the Southern African Development Community (SADC) collaborative medicines registration initiative. ZaZiBoNa has resulted in great savings in time and resources; however, identified challenges include lack of clear information regarding the participating countries registration processes and requirements as well as lengthy registration times. The aim of this study, therefore, was to compare the data requirements and review models employed in the assessment of applications for registration, the target timelines for key milestones and the metrics of applications received and approved in 2019 and 2020 by Mozambique, Namibia, South Africa, Tanzania, Zambia, and Zimbabwe.Methods: A senior member of the division responsible for issuing marketing authorisations completed an established and validated questionnaire, which standardizes the review process, allowing key milestones, activities and practices of the six regulatory authorities to be identified and compared. The completed questionnaires were validated by the heads of the respective agencies.Results: The majority of applications received and approved by all six agencies in 2019 and 2020 were for generics. The mean approval times for generics varied across the countries, with ranges of 218–890 calendar days in 2019 and 158–696 calendar days in 2020. All three types of scientific assessment review models were used by the six agencies and data requirements and extent of scientific assessment were similar for five countries, while one conducted full reviews for new active substances. A large variation was observed in the targets set by the six agencies for the different milestones as well as overall approval times.Conclusions: The study identified the strengths of the countries as well as opportunities for improvement and alignment. Implementation of the recommendations made as in this study will enhance the countries' individual systems, enabling them to efficiently support the ZaZiBoNa initiative.

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

“…Although the ZaZiBoNa initiative has been in operation for8 years, the process for submission in some countries remains unclear to applicants ( 15 ). This, in addition to a number of other challenges identfied in this study such as failure by some countries to register medicines and issue GMP certificates within the set timelines after a ZaZiBoNa recommendation, can be attributed to the participating authorities having differing capacities ( 14 , 18 ). Centralised submission and tracking were therefore proposed by both regulators and industry as ways to improve the effectiveness and efficiency of this initiative.…”

“…All 16 SADC countries, Angola, Botswana, Comoros Islands, Democratic Republic of Congo, Eswatini, Lesotho, Madagascar, Malawi, Mauritius, Mozambique, Namibia, Seychelles, South Africa, United Republic of Tanzania, Zambia, and Zimbabwe ( 12 ), participate in the initiative as either active or non-active members ( 7 ). As at December 2021, 333 dossiers/applications had been assessed under the ZaZiBoNa initiative with a median time to recommendation of 12 months ( 13 ), which is much shorter than the timelines reported by some of the participating countries for their national procedures ( 14 ). Although some feedback on the performance of the initiative has been sought from manufactures through stakeholder meetings in the past, there has not been a comprehensive and structured evaluation of the work-sharing programme for its future direction.…”

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

“…The results of this study show that the ZaZiBoNa initiative has achieved the majority of its objectives, which included facilitating greater information sharing and harmonisation of registration requirements. The capacity of countries to conduct assessments and inspections has markedly improved as a result of their participation in this initiative ( 4 , 10 ). Reliance is being implemented within the initiative, as countries can quickly approve dossiers/applications that they have not reviewed but whose reports can be accessed through ZaZiBoNa.…”

“…This could be due to the significantly lower resources; for example, the number of assessors, available to ZaZiBoNa countries when compared with countries in the other initiatives. Most of the active member countries in ZaZiBoNa are faced with the challenge of limited resources and a high number of applications ( 4 , 10 , 15 – 17 ) for the national procedure, which negatively impacts the work-sharing initiative. The use of a regional unit to coordinate assessments would also assist in addressing the identified challenges, particularly in a resource-constrained setting.…”

“…Another important initiative accomplishment is the achievement of shorter timelines for the 333 dossiers/applications that have been assessed to date (December 2021) compared with the timelines achieved by some of the participating countries using their national procedures ( 6 , 8 ). For example, ZaZiBoNa has an overall median time to recommendation of 12 months ( 9 ), whereas some of the participating countries had approval times of over 650 days in 2020 ( 10 ). The gap in regulatory capacity among participating countries has also been reduced through the training of assessors and inspectors, bringing further harmonisation in the way assessments and GMP inspections are conducted in the SADC region.…”