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Evaluation of the Food and Drugs Authority, Ghana Regulatory Review Process: Challenges and Opportunities

Purpose: This study aimed to assess the current regulatory review process of the food and drugs authority (FDA) Ghana by identifying key milestones, target timelines, good review practices and [...]

Juan Lara2022-11-14T16:19:41+00:00November 14th, 2022|Tags: Africa, OpERA, Regulatory|
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Evaluation of the East African Community joint assessment procedure by pharmaceutical companies

Background: A 2021 study to determine the viewpoints among the seven member countries regarding the effectiveness (i.e., achieving the intended outcomes) and efficiency (i.e., achieving the intended outcomes in [...]

Juan Lara2022-11-09T16:41:36+00:00November 9th, 2022|Tags: Africa, OpERA, Regulatory, Work sharing|
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Evaluation of the East African Community joint assessment

Background: For almost a decade, the East African Community has implemented the Medicines Regulatory Harmonization (EAC-MRH) programme among its member states to harmonise technical requirements and standards for medical [...]

Jenny Sharpe2022-08-31T16:17:17+00:00September 1st, 2022|Tags: Africa, OpERA, Regulatory, Work sharing|
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Evaluation of the performance of the Gulf centralised registration procedure

Background: The Gulf Centralised Committee for Drug Registration (GCC-DR), as part of the Gulf Health Council (GHC), enables the consolidated registration of pharmaceutical products throughout the member states of [...]

Jenny Sharpe2022-07-19T09:06:58+00:00July 19th, 2022|Tags: Middle East, OpERA, Regulatory|
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Industry evaluation of the efficiency and effectiveness of ZaZiBoNa

Introduction: The common technical document (CTD) format harmonised the requirements for the registration of medicines, which had traditionally differed from country to country, making it possible for countries to [...]

Jenny Sharpe2022-05-12T08:55:14+00:00May 12th, 2022|Tags: Africa, OpERA, Regulatory|
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Regulatory evaluation of the efficiency and effectiveness of ZaZiBoNa

Introduction: ZaZiBoNa, the work-sharing initiative in the Southern African Development Community (SADC) that has been in operation for 8 years has successfully assessed over 300 dossiers/applications, with an overall [...]

Jenny Sharpe2022-05-12T08:54:54+00:00May 12th, 2022|Tags: Africa, OpERA, Regulatory|
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Comparison of the registration process of Zimbabwe with Australia, Canada, Singapore and Switzerland

Background: Benchmarking regulatory systems of low- and middle-income countries with mature systems provides an opportunity to identify gaps, enhance review quality, and reduce registration timelines, thereby improving patients’ access [...]

Jenny Sharpe2022-01-31T14:13:51+00:00November 9th, 2021|Tags: Africa, OpERA, Regulatory|
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Review models and timelines in the Southern African Development Community

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 [...]

Jenny Sharpe2021-10-13T10:19:56+00:00October 13th, 2021|Tags: Africa, OpERA, Regulatory|
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Good Review Practices in the Southern African Development Community

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 [...]

Jenny Sharpe2021-10-13T10:19:41+00:00October 13th, 2021|Tags: Africa, OpERA, Regulatory|
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Keyter et al 2021 – Impact of reliance on South African review

Background: The aims of this study were to compare the overall regulatory review timelines achieved by the South African Health Products Regulatory Authority (SAHPRA) in 2020 to the timelines historically [...]

Jenny Sharpe2022-01-31T14:04:33+00:00September 2nd, 2021|Tags: Africa, OpERA, Regulatory, Reliance|
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  • Home
  • About
    • Mission
    • Governance
    • History
    • Meet the team
  • Research
    • Research strategy
    • Regulatory
      • Mature agency benchmarking
      • Regulatory strengthening (OpERA)
      • Growth & emerging markets metrics
    • HTA
      • HTA agency benchmarking
      • HTA industry metrics
      • Regulatory and Reimbursement Atlas
  • News
  • Publications
  • Membership
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