Evaluating the Success of ZaZiBoNa, the Southern African Development Community Collaborative Medicines Registration Initiative

AbstractThe Southern African Development Community (SADC) collaborative medicines registration initiative ZaZiBoNa is a successful regional work-sharing initiative on the African continent. This paper reviews the history of the ZaZiBoNa initiative, reflects on what has been realized in six years of operation and what still needs to be achieved. Statistics for the work done by the initiative are available in the literature, but there has not been a critical review of the process, including an analysis of factors contributing to the success of the initiative and conversely those negatively affecting performance. To do this, publicly available literature and statistics, meeting records, terms of reference and unpublished documents belonging to the initiative were reviewed. The successes of the ZaZiBoNa initiative can be attributed to leadership commitment, a clear vision and governance structure providing direction, and a clear, documented operating model, processes and objectives defined from the onset of the initiative. Closure of the gaps that were identified and implementation of the recommendations that were made in this paper will further strengthen the initiative. Furthermore, other regional harmonization or work-sharing initiatives on the African continent and beyond can draw lessons from this review of the ZaZiBoNa initiative for improved efficiency and effectiveness.

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

Frontiers in Medicine ◽

10.3389/fmed.2021.742200 ◽

2021 ◽

Vol 8 ◽

Cited By ~ 1

Author(s):

Tariro Sithole ◽

Gugu Mahlangu ◽

Velma Capote ◽

Tania Sitoie ◽

Saren Shifotoka ◽

...

Keyword(s):

Southern African Development Community ◽

African Development ◽

Work Sharing ◽

Senior Member ◽

Scientific Assessment ◽

Validated Questionnaire ◽

The Mean ◽

Data Requirements ◽

Clear Information ◽

Active Substances

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.

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Industrialising the Southern African Development Community (SADC) Economies: Prospects and Challenges

Journal of Social Science Studies ◽

10.5296/jsss.v3i2.8825 ◽

2016 ◽

Vol 3 (2) ◽

pp. 1

Author(s):

John Bosco Nizeimana ◽

Alfred G. Nhema

Keyword(s):

Economic Growth ◽

Economic Development ◽

Social Change ◽

Growth And Development ◽

Southern African Development Community ◽

Economic Importance ◽

African Continent ◽

Economic Growth And Development ◽

African Development ◽

Job Opportunities

<p>This article examines the prospects and challenges of industrialisation as a tool for economic development in the Southern African Development Community (SADC) region. The economic importance of industrialisation is enshrined in its capacity to create job opportunities and facilitate synergies between and among various sectors of the economy. The paper posits that industrialisation is an engine for economic development that can promote sustainable positive social change in any given society. While the perceived view is that, in general, the industrialisation process in Africa has been disappointing; the Southern African Development Community (SADC) has committed itself towards embracing the concept of industrialisation as a tool for economic growth and development. Thus, given the historical failure of this concept on the African continent, it is important to analyse the prospects and challenges likely to be faced by the SADC region in their bid to hasten the industrialisation of their countries. Substantively, the paper relied on documentary research.</p>

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AN APPRAISAL OF SOURCE MATERIAL FOR THE STUDY OF TARGUM MINOR PROPHETS

Journal for Semitics ◽

10.25159/1013-8471/3462 ◽

2017 ◽

Vol 24 (2) ◽

pp. 451-469

Author(s):

Gudrun Lier ◽

Anna Fransina Van Zyl

Keyword(s):

Source Material ◽

Bible Translations ◽

Integrated Research ◽

Translation Techniques ◽

Former Prophets ◽

History Of ◽

The Individual ◽

History Of Biblical Interpretation ◽

Work Done ◽

Minor Prophets

The study of Aramaic Bible translations (Targumim) continues to be a valuable source of information, not only for uncovering the history of biblical interpretation but also for providing insights for the study of linguistics and translation techniques. In comparison with work done on the Pentateuchal Targumim and Targum Former Prophets, research on the individual books of Targum Minor Prophets has been scant. By providing an overview of selected source material this review seeks (i) to provide incentives for more focussed studies in the field of Targum Minor Prophets and (ii) to motivate new integrated research approaches which are now made possible with the assistance of highly developed software programmes.

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Southern African Development Community (SADC) Tribunal

SSRN Electronic Journal ◽

10.2139/ssrn.3405935 ◽

2016 ◽

Author(s):

Henok Asmelash

Keyword(s):

Southern African Development Community ◽

African Development

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The SADC Tribunal

10.1093/oso/9780198795582.003.0006 ◽

2018 ◽

Cited By ~ 3

Author(s):

E. Tendayi Achiume

Keyword(s):

Human Rights ◽

Significant Role ◽

Economic History ◽

Southern African Development Community ◽

The Other ◽

Legal Decision ◽

African Development ◽

Sociopolitical Context ◽

Judicial Lawmaking

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.

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Recent Developments in the Regulation of Investor-State Dispute Resolution: Any Lessons for the Southern African Development Community?

African Journal of Legal Studies ◽

10.1163/17087384-12340021 ◽

2017 ◽

Vol 10 (2-3) ◽

pp. 180-204

Author(s):

Lawrence Ngobeni ◽

Babatunde Fagbayibo

Keyword(s):

Dispute Resolution ◽

Free Trade ◽

Free Trade Area ◽

Trade Agreement ◽

Southern African Development Community ◽

African Union ◽

Foreign Investments ◽

African Development ◽

Trade Area ◽

Recent Developments

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.

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