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 insurancecovering:
  • 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.