Building resilient research ethics, Diagnostics and medicines regulatory capacity during routine and public health emergency periods

Project Information

BREEDIME

Grant agreement ID: 101103217

DOI

10.3030/101103217

Project closed

EC signature date 2 May 2023

Start date 1 June 2023

End date 31 May 2026

Funded under

• Health

Total cost

€ 599 637,50

EU contribution

€ 599 637,50

Coordinated by

KAROLINSKA INSTITUTET
Sweden

Periodic Reporting for period 1 - BREEDIME (Building resilient research ethics, Diagnostics and medicines regulatory capacity during routine and public health emergency periods)

Reporting period: 2023-06-01 to 2024-11-30

Summary of the context and overall objectives of the project

Context and Objectives
Regulatory and ethics bodies in Low- and Middle-Income Countries (LMICs) require well-trained experts to rapidly assess therapeutic and vaccine clinical trials, especially during infectious disease outbreaks. The COVID-19 pandemic exposed significant gaps in regulatory preparedness, highlighting the need for stronger ethics frameworks, rapid clinical trial evaluation, and capacity building in Sub-Saharan Africa.
Despite existing policies, many LMICs lack a stable emergency response framework, making it difficult to ensure the quality, safety, and efficacy of medical interventions. BREEDIME addresses these challenges by strengthening regulatory capacity, fostering regional collaboration, and improving oversight of clinical trials and medical products.

Goals and Objectives
BREEDIME aims to enhance regulatory and ethical capacities in SSA for clinical trials and medical product evaluation, particularly during public health emergencies.

Specific Objectives:
• Build capacity for rapid evaluation of therapeutic and vaccine trials.
• Strengthen regulatory frameworks for in vitro diagnostics and critical medical devices.
• Establish ethical guidelines for health data access and sharing.
• Enhance post-market surveillance for medicines and medical devices.
• Promote South-South collaboration in regulatory and clinical trial oversight.

Pathway to Impact
1. Capacity Building for Rapid Clinical Trial Evaluation
• Develop specialized training for clinical trial assessors across SSA.
• Enhance regulatory authorities' ability to conduct timely and rigorous trial assessments.
2. Strengthening Regulatory Frameworks for Medical Devices & Diagnostics
• Train regulators in diagnostic kits performance evaluations.
• Develop SOPs and standardized evaluation protocols.
3. Establishing Ethical Guidelines for Health Data Access & Sharing
• Create clear policies aligned with international standards.
• Ensure responsible data use for evidence-based decision-making.
4. Enhancing Post-Market Surveillance
• Implement risk-based sampling and patient information reviews.
• Train regulators in compliance monitoring and corrective actions.
5. Fostering South-South Collaboration
• Facilitate expert exchanges between Tanzania, Zanzibar, and Rwanda.
• Expand on past EDCTP projects to strengthen regional regulatory capacity.
Expected Impact
• Improve clinical trial evaluation speed and efficiency during emergencies.
• Strengthen regulatory oversight for diagnostics and medical devices.
• Ensure ethical and responsible health data management.
• Enhance post-market surveillance to maintain medical product safety.
• Foster a sustainable regional regulatory network to support future health crises

Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far

1. Capacity Building for Clinical Trial Evaluation
• Developed and implemented four specialized short courses for clinical trial assessors from TMDA, ZFDA, and Rwanda FDA.
• Developed standardized curricula and assessment tools to ensure long-term sustainability.
• Achieved improved evaluation capacity for clinical trials during public health emergencies.
2. Strengthening Regulatory Frameworks for Medical Devices and Diagnostics
• Developed detailed guidance documents, SOPs, and evaluation protocols for the performance evaluation of diagnostic test kits
• Conducted training for regulatory authorities on the performance evaluation of high-risk in vitro diagnostics (IVDs), including HIV/AIDS, malaria, syphilis, hepatitis B and C, and SARS-CoV-2.
3. Development of Regulatory and Ethical Guidelines for Health Data Access
• Established a health data governance framework.
• Developed protocols for data collection, storage, and access, focusing on clinical research data. These guidelines address ethical considerations, data sharing, and public health emergency protocols.
4. Post-Market Surveillance Enhancement
• Developed and executed sampling protocols in collaboration with TMDA, ZFDA, and Rwanda FDA for high-risk medicines and medical devices and diagnostic test kits.
• Trained 60 sample collectors on data entry, analysis, and regulatory actions. A Patient Information Review (PIR) protocol was also established to assess compliance with WHO standards.
• Established a risk-based post-market surveillance system to monitor medicines and medical devices.
5. South-South Collaboration and Regulatory Benchmarking
• Launched a regional benchmarking initiative to facilitate knowledge exchange between regulatory bodies in Tanzania, Zanzibar, and Rwanda.
• Conducted technical staff rotations for cross-learning on clinical trial oversight and regulatory best practices.

Main Scientific Achievements:
• Developed standardized clinical trial evaluation frameworks.
• Created regulatory guidelines for the performance evaluation of in vitro diagnostics.
• Established a structured health data governance framework compliant with GDPR.
• Implemented a robust post-market surveillance system.
• Strengthened South-South collaboration through technical exchanges and benchmarking.

Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far)

Enhanced Regulatory Capacity:
Developed tailored training programs and curricula for clinical trial assessors, regulatory inspectors, and ethics reviewers in Tanzania, Zanzibar, Rwanda.
Strengthened regulatory processes through expedited review training, ethical oversight, and diagnostic performance evaluation.
Post-Market Surveillance Improvements: Established risk-based monitoring protocols for medicines and diagnostics.
South-South Collaboration: Launched mentorship between Tanzania and Rwanda, fostering regional network.

Potential Impacts:
Improved Clinical Trial Oversight: Faster and more efficient regulatory processes during public health emergencies.
Sustainable Capacity Building: Standardized curricula ensure long-term professional development.
Regional and International Alignment: Strengthened harmonization of regulatory frameworks in East Africa.

Key Needs for Further Uptake:
Further Research & Demonstration: Adapting training programs to evolving public health challenges.
Funding & Market Access: Securing financial support for broader implementation.
Policy Integration & International Expansion: Embedding training into national frameworks and expanding to other regions.
Future Outlook:

Expansion of training to additional African countries.

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