scholarly journals Evaluation of the Review Models and Approval Timelines 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 ◽  
...  
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.

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 ◽  
...  
Keyword(s):  
Review Process ◽  
Southern African Development Community ◽  
Common Finding ◽  
Expert Committee ◽  
African Development ◽  
Senior Member ◽  
Regulatory Authorities ◽  
Validated Questionnaire ◽  
Good Review ◽  
Technical Capacity

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.

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

2020 ◽  
Vol 54 (6) ◽  
pp. 1319-1329 ◽  
Author(s):  
Tariro Sithole ◽  
Gugu Mahlangu ◽  
Sam Salek ◽  
Stuart Walker
Keyword(s):  
Governance Structure ◽  
Southern African Development Community ◽  
African Continent ◽  
African Development ◽  
Work Sharing ◽  
Clear Vision ◽  
Efficiency And Effectiveness ◽  
History Of ◽  
Work Done ◽  
Regional Work

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.

The SADC Tribunal

2018 ◽  
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.

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

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.

scholarly journals Single-use plastic bag policies in the Southern African development community

2021 ◽  
Vol 3 ◽  
pp. 100029
Author(s):  
Joana Carlos Bezerra ◽  
Tony Robert Walker ◽  
C Andrea Clayton ◽  
Issahaku Adam
Keyword(s):  
Southern African Development Community ◽  
African Development ◽  
Plastic Bag ◽  
Single Use

Prospective assessment of urinary and bowel symptoms, and sexual function between laparoscopic assisted vaginal radical trachelectomy and radical hysterectomy

2021 ◽  
Vol 31 (3) ◽  
pp. 484-489
Author(s):  
Nasuh Utku Dogan ◽  
Christhardt Kohler ◽  
Tatiana Pfiffer ◽  
Andrea Plaikner ◽  
Xin Le ◽  
...  
Keyword(s):  
Sexual Function ◽  
Radical Hysterectomy ◽  
Postoperative Phase ◽  
Radical Trachelectomy ◽  
Bowel Symptoms ◽  
Validated Questionnaire ◽  
Grade Ii ◽  
The Mean ◽  
Urinary Morbidity ◽  
Laparoscopic Assisted

ObjectiveRadical trachelectomy is a valid alternative to radical hysterectomy in women with a desire to retain their fertility. Data regarding the oncological outcomes of radical trachelectomy are comparable with those of radical hysterectomy but information regarding urinary and sexual function is limited. The aim of this study was to prospectively evaluate and compare quality of life, urinary and bowel symptoms, and sexual dysfunction between patients who underwent laparoscopic assisted vaginal radical trachelectomy versus radical hysterectomy for early-stage cervical cancer.MethodsPatients who underwent laparoscopic assisted vaginal radical trachelectomy or radical hysterectomy along with sentinel or systemic pelvic lymphadenectomy were included between May 2015 and January 2017. Patients were asked to complete a validated questionnaire (German pelvic symptom questionnaire) on bladder, bowel, prolapse, and sexual function, and total pelvic score, at least 48 hours before surgery and 6 months after surgery.ResultsA total of 51 patients were included. Of these, 26 patients (50.9%) underwent laparoscopic assisted vaginal radical trachelectomy and 25 (49.1%) underwent radical hysterectomy. No patient was converted to laparotomy. The majority of patients (76%) were diagnosed with International Federation of Gynecology and Obstetrics (FIGO 2018) stage 1B1 disease, with squamous cell carcinoma (54%) and grade II tumors (52%). Four patients (7.8 %) experienced perioperative complications (two grade II and two grade III complications according to the Clavien–Dindo classification). In the preoperative evaluation, the median scores for the four items of the questionnaire (bladder, bowel, prolapse, and sexual items) and total pelvic score were comparable between the two groups. The mean scores for radical hysterectomy and radical trachelectomy at the beginning of the study for bladder, bowel, prolapse, and sexual function were 0.93 versus 0.71, 0.71 versus 1.01, 0.12 versus 0.1, and 1.06 versus 1.0, respectively. On preoperative testing, the median scores for all four items of the questionnaire (pbladder=0.821, pbowel=0.126, pprolapse=0.449, psexual=0.965) and the total pelvic score (p=0.756) were comparable between the two groups. The radical hysterectomy group had worse total pelvic scores at the 6 month postoperative survey compared with baseline (p=0.03). There was no difference in bladder (p=0.07) or bowel symptoms (p=0.07) in the radical hysterectomy group comparing baseline with the 6 month assessment. Women undergoing radical hysterectomy experienced more urinary morbidity than women undergoing vaginal trachelectomy at 6 weeks (p=0.025). However, the mean bladder and pelvic scores in the 6 month control were comparable between patients who had and those who had not experienced urinary morbidity (pbladder=0.127, ptotal pelvic score=0.480).ConclusionPatients undergoing laparoscopic assisted vaginal radical trachelectomy had similar pelvic scores in both the preoperative and postoperative periods. However, patients undergoing radical hysterectomy showed worse total pelvic scores on the postoperative assessment compared with the baseline evaluation. Urinary dysfunction in the early postoperative phase was more common in the radical hysterectomy group than in trachelectomy group.

Sign in / Sign up

Export Citation Format

Share Document