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

Tariro Sithole,Sam Salek,Zuma Munkombwe,Johannes Gaeseb,Portia Nkambule,Velma Capote,Tania Sitoie,Gugu Mahlangu,Stuart Walker,Bernice Mwale,Alex Juma,Lorraine Danks,Adam Fimbo,Saren Shifotoka

doi:10.3389/fmed.2021.742200

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.

Highlights

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
In the first paper of this two part-series, we evaluated and compared the regulatory review processes of the regulatory authorities of Mozambique, Namibia, South Africa, Tanzania, Zambia, and Zimbabwe, who are active members of the ZaZiBoNa initiative and proposed recommendations for better alignment The aim of this paper, the second and last in the series, 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 the six countries
The six regulatory agencies included in this study were the National Directorate of Pharmacy in the Mozambique Ministry of Health; Namibia Medicines Regulatory Council (NMRC) in the Namibia Ministry of Health and Social Services; the South African Health Products Regulatory Authority (SAHPRA); the Tanzania Medicines and Medical Devices Authority (TMDA); the Zambian Medicines Regulatory Authority (ZAMRA); and the Medicines Control Authority of Zimbabwe (MCAZ)

Summary

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. One function, performed by regulatory authorities worldwide to fulfill their mandate, is the process of reviewing applications for registration or market authorization submitted by companies interested in marketing their products in a particular country or jurisdiction. This process can be long in some countries, hindering access to life-saving medicines by patients and this has led to regulatory agencies relying on the reviews and decisions of other regulators [2]. The World Health Organization (WHO) has published its guidance on good reliance practices [3] and recommends the use of reliance to effectively and efficiently perform regulatory functions in a timely and costeffective manner

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