Africa CDC has defined a comprehensive, Africa-relevant checklist of conditionalities that an external company (sponsor) must meet to conduct a vaccine clinical trial in an African country.
This guidance includes several steps below:
1. National Regulatory Authorization (Mandatory)
Before any trial activity:
a) National Medicines Regulatory Authority (NMRA)
The sponsor must obtain written authorization from the country’s NMRA (e.g., Pharmacy Board, Medicines Control Authority).
This typically requires submission of:
- Clinical Trial Application (CTA)
- Full protocol (ICH-GCP compliant)
- Investigator’s Brochure (IB)
- Pre-clinical and Phase I/II data
- Chemistry, Manufacturing and Controls (CMC)
- Risk–benefit assessment
- Safety monitoring plan (DSMB)
➡️ No NMRA approval = illegal trial
2. Ethics Approval (Mandatory and Independent)
a) National Ethics Committee (NEC)
- Approval by the national ethics committee is required
- Must review scientific merit, participant safety, and ethical integrity
b) Institutional Review Board (IRB)
- Local IRB approval at each trial site (hospital, research institute)
Ethics review must confirm:
- Voluntary participation
- Cultural appropriateness
- Risk minimization
- Protection of vulnerable populations
3. Government Authorization & Political Clearance
Many African countries require explicit government clearance, often through:
- Ministry of Health
- Office of the Minister
- Inter-ministerial committee (Health, Justice, Interior)
This ensures:
- Alignment with national health priorities
- No contradiction with national immunization policies
- National ownership
4. Legal & Contractual Requirements
a) Clinical Trial Agreement (CTA)
Between:
- Sponsor
- Local institution
- Government (often MoH)
Must define:
- Roles and responsibilities
- Data ownership
- Publication rights
- IP clauses
- Compensation mechanisms
b) Indemnity & Insurance
Sponsor must provide:
- No-fault insurance covering:
- Trial-related injury
- Disability
- Death
- Proof of coverage valid in that country
5. Informed Consent (Strict Requirement)
- Written informed consent in local languages
- Plain, non-technical language
- Includes:
- Risks and benefits
- Right to withdraw
- Confidentiality
- Compensation for harm
Special protections required for:
- Children
- Pregnant women
- Illiterate participants
- Refugees or displaced populations
6. Compliance with International Standards
Trials must comply with:
- ICH-GCP
- Declaration of Helsinki
- CIOMS Guidelines
- WHO Good Clinical Practice
Non-compliance is grounds for trial suspension or termination.
7. Local Scientific & Institutional Partnership
Most African countries require:
- A local Principal Investigator (PI)
- Collaboration with:
- National research institute
- University or teaching hospital
- Capacity-building component (often explicit)
This includes:
- Training of local staff
- Strengthening labs or surveillance
- Technology transfer where feasible
8. Data Governance & Sovereignty
Increasingly critical across Africa:
Sponsors must clarify:
- Where data will be stored on the continent and level of access clearly defined
- Who owns primary data
- Conditions for data export
- Access for national authorities
Some countries require:
- Local data hosting
- Government access to anonymized datasets
- Approval before publication
9. Safety Monitoring & Reporting
Mandatory:
- Data Safety Monitoring Board (DSMB)
- Serious Adverse Event (SAE) reporting within defined timelines
- Immediate notification to:
- NMRA
- Ethics committees
- Ministry of Health
Failure to report SAEs can trigger trial suspension.
10. Importation & Customs Clearance
Sponsor must secure:
- Import permits for:
- Investigational vaccine
- Placebo
- Biological samples
- Cold chain compliance documentation
Often coordinated with:
- NMRA
- Customs
- National immunization/logistics units
11. Community Engagement & Social License
Many countries now require:
- Community sensitization plans
- Engagement with:
- Community leaders
- Civil society
- Patient groups
This is critical to:
- Prevent misinformation
- Ensure trust
- Avoid social backlash
12. Post-Trial Obligations (Increasingly Enforced)
Sponsors may be required to commit to:
- Post-trial access to successful vaccines
- Affordable pricing
- Technology transfer or local manufacturing discussions
- Feedback of results to participants and government
- Findings from all trial to be provided to participants, national governments and regional bodies
13. Regional / Continental Coordination (Emerging Best Practice)
While not always legally mandatory, many countries expect alignment with:
- Africa CDC guidance
- Regional Economic Community (REC) frameworks
- WHO AFRO norms
This is strongly encouraged for multi-country trials.
