scholarly journals Evaluation of the Good Review Practices of Countries Participating in the Southern African Development Community: Alignment and Strategies for Moving Forward

2021 ◽  
Vol 8 ◽  
Author(s):  
Tariro Sithole ◽  
Gugu Mahlangu ◽  
Velma Capote ◽  
Tania Sitoie ◽  
Saren Shifotoka ◽  
...  

Introduction: National medicines regulatory agencies are faced with challenges including limited resources and technical capacity, resulting in countries collaborating and sharing resources to improve efficiency of the review process to facilitate access to quality-assured medicines by their populations. One such collaboration is the Southern African Development Community (SADC) medicines registration collaborative initiative, ZaZiBoNa. Countries participate in the initiative by contributing to regulatory reviews and good manufacturing practices inspections. The aim of this study was to review and compare the registration processes of regulatory authorities of Mozambique, Namibia, South Africa, Tanzania, Zambia, and Zimbabwe to identify strategies for better alignment.Methods: A senior member of the division responsible for issuing marketing authorisations completed an established and validated questionnaire, which standardises 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 six countries vary in population and in the size of their respective regulatory agency and the resources allocated to regulatory reviews. The review processes of the six agencies were similar; however, differences were noted in the milestones recorded; for example, two of the countries did not record the start of the scientific assessment. Additionally, decisions for marketing authorisation were made by an expert committee in four of the countries and by the head of the agency and the Minister of Health in two countries. All six agencies implemented the majority of good review practices; however, the need for improvement in the areas of transparency and communication and quality decision making practices was a common finding for all six countries.Conclusions: Participation in the ZaZiBoNa initiative has improved the way in which the six agencies perform regulatory reviews in their countries, highlighting the realisation of one of the key objectives of the initiative, which was building the expert capacity of member countries. Other agencies in the SADC region and beyond can use the results of this study to identify best practices, which in turn, could improve their regulatory performance.

2021 ◽  
Vol 8 ◽  
Author(s):  
Tariro Sithole ◽  
Gugu Mahlangu ◽  
Velma Capote ◽  
Tania Sitoie ◽  
Saren Shifotoka ◽  
...  

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.


Author(s):  
E. Tendayi Achiume

This chapter uses the trajectory of the Southern African Development Community (“SADC”) Tribunal to chart sociopolitical constraints on international judicial lawmaking. It studies the SADC Tribunal backlash case, which paved the way for a curtailment of the Tribunal’s authority, stripping the Tribunal of both private access and its jurisdiction over human rights. Showing how jurisprudential engagement with sociopolitical context plays a significant role in explaining the Tribunal's loss of authority, the chapter introduces the concept of sociopolitical dissonance. Sociopolitical dissonance is a state that results when a legal decision contradicts or undermines deeply held norms that a given society or community forms on the basis of its social, political, and economic history. Sociopolitical resonance, on the other hand, describes the quality of affirming or according with a given society's norms as informed by its sociopolitical history.


2017 ◽  
Vol 10 (2-3) ◽  
pp. 180-204
Author(s):  
Lawrence Ngobeni ◽  
Babatunde Fagbayibo

Abstract In 2016, the Southern African Development Community (SADC) amended Annex 1 of the SADC Protocol on Finance and Investment (FIP) in order to remove investor access to international arbitration or Investor-State Dispute Resolution (ISDS). The recent formation of the African Continental Free Trade Area (AfCFTA) and the COMESA-EAC-SADC Tripartite Free Trade Agreement (T-FTA) are factors that will likely curtail SADC’s ability to regulate foreign investments. Both AfCFTA and T-FTA are supposed to have their own investment protocols. This means that SADC faces the loss of regulatory authority over foreign investments. The recent formation of the Pan African Investment Code (PAIC) has shown that some African Union (AU) Member States want to provide ISDS for their investors, while others including SADC Members States do not. This article intends to evaluate the lessons SADC can learn from other jurisdictions in terms of the effective regulation of ISDS.


2021 ◽  
Vol 3 ◽  
pp. 100029
Author(s):  
Joana Carlos Bezerra ◽  
Tony Robert Walker ◽  
C Andrea Clayton ◽  
Issahaku Adam

2017 ◽  
Vol 141 ◽  
pp. 352-359 ◽  
Author(s):  
Daniel Adu ◽  
Jinfeng Zhang ◽  
Yujian Fang ◽  
Lv Suoming ◽  
Ransford O. Darko

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