The Global Grand Challenges initiative is currently accepting applications for the “Strengthening African National Regulatory Authorities Data Systems to Enhance and Track Performance” grant. This opportunity aims to address critical challenges within African National Regulatory Agencies (NRAs) and contribute to the broader goal of achieving WHO maturity level 3 (ML3).
Objectives
The call for applications is driven by the need to overcome four key challenges faced by NRAs in Africa:
- Lack of clear internal processes for managing regulatory pathways.
- Absence of clearly defined Key Performance Indicators (KPIs).
- Inadequate data systems for capturing and reporting essential metrics.
- Lack of harmonized scalable solutions that can be interoperable across multiple NRAs.
Eligibility
Applications are invited from African NRAs, with a requirement for active collaboration between at least two NRAs per application. Proposals must address at least two of the following categories:
- Regulatory review process management
- Metrics systems and performance indicators improvement
- Regulatory Data Standardization and data vocabulary
- Artificial Intelligence (AI) centered tools
Funding Details
The Global Grand Challenges will fund up to 5 proposals, with each successful proposal receiving an award of up to USD $300,000 for an 18- to 24-month grant duration. At least 80% of the funding should directly benefit NRAs.
Application Deadline: Interested parties should submit their proposals by January 31, 2024.
Background and Opportunity
Insufficient access to quality and affordable medical products in Africa has long been a public health challenge. The establishment of the African Medicines Agency (AMA) is a crucial step in addressing this issue by facilitating coordination and harmonization across Member States. The Bill & Melinda Gates Foundation, along with other stakeholders, has been actively supporting the harmonization of regulatory processes in Africa, emphasizing the importance of NRAs reaching WHO ML3.
Despite progress, challenges persist, including disparities among NRAs, manual regulatory processes, and inadequate digital support. The lack of robust data systems hinders the ability to define, oversee, and report on processes, impacting organizational strategic planning.
Funded Projects
Successful proposals will be part of a larger coordinated program aimed at strengthening African NRAs’ data systems. Funded projects will collaborate on shared interests such as knowledge exchange and harmonization of solutions, contributing to the attainment of ML3.
Criteria for Successful Proposals
Proposals must:
- Involve at least one NRA operating at WHO ML3 level.
- Allocate at least 80% of the funding to NRAs.
- Demonstrate collaboration between at least 2 NRAs.
- Have the potential to impact proposed areas within the budget and timeframe.
- Ensure resources are procured within the first 3-4 months.
- Exhibit a shared commitment to collaboration, information sharing, and system advancement.
- Include change management and implementation plans.
- Demonstrate sustainability beyond the grant period.
Exclusions
Proposals not involving an ML3 NRA, led by non-African institutions, lacking a commitment to collaboration, exceeding the grant term, or deviating from the call’s scope will not be considered.
Empowering African Regulatory Systems: A Strategic Initiative for Public Health, Collaboration, and Sustainable Progress
The “Strengthening African National Regulatory Authorities Data Systems to Enhance and Track Performance” grant represents a critical initiative with significant importance for Africans, particularly in the realm of public health and access to quality medical products. Here are several key reasons why this grant is essential for African National Regulatory Authorities (NRAs) and the broader population:
- Public Health Impact: The grant directly addresses the longstanding public health challenge of insufficient access to quality and affordable medical products in Africa. By strengthening the data systems of NRAs, the initiative contributes to improving the regulatory processes and ensuring the availability of safe and effective medicines for the population.
- Harmonization and Coordination: The establishment of the African Medicines Agency (AMA) is a vital step in promoting coordination and harmonization across Member States. The grant aligns with these efforts, emphasizing the need for NRAs to reach WHO maturity level 3 (ML3). Harmonized regulatory processes are crucial for streamlining the approval and monitoring of medical products across borders.
- Progress Tracking and Accountability: The absence of clearly defined Key Performance Indicators (KPIs) and inadequate data systems hinder progress tracking and accountability within NRAs. This grant provides an opportunity to address these challenges, enabling NRAs to set measurable goals, track their performance, and be accountable for their regulatory activities.
- Digital Transformation: Inadequate digital support and manual regulatory processes have been identified as challenges. The grant encourages the use of Artificial Intelligence (AI)-centered tools and the improvement of data systems, promoting a digital transformation that can enhance efficiency, accuracy, and the overall effectiveness of regulatory processes.
- Knowledge Exchange and Collaboration: The call for active collaboration between at least two NRAs per application underscores the importance of knowledge exchange and collaborative efforts. Successful proposals will be part of a larger coordinated program, fostering a community of practice where NRAs can share insights, best practices and collectively contribute to strengthening regulatory systems.
- Financial Support for NRAs: The funding details indicate a substantial financial commitment, with each successful proposal receiving up to USD $300,000. At least 80% of the funding is required to directly benefit NRAs, providing crucial financial support to implement necessary changes and improvements.
- Sustainability and System Advancement: The criteria for successful proposals emphasize sustainability beyond the grant period and a shared commitment to collaboration and system advancement. This ensures that the impact of the grant extends beyond the initial funding, leading to lasting improvements in the regulatory landscape.
In conclusion, this grant is not only a financial opportunity for NRAs but a strategic initiative that addresses critical challenges, promotes collaboration, and contributes to the overall well-being of African populations by ensuring access to safe and effective medical products. It represents a step towards a more robust and mature regulatory environment that aligns with global standards and priorities.
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