Quote from VigiServe Admin on November 28, 2020, 8:33 AM

In Rwanda, Pharmacovigilance is regulated by the Rwanda Food and Drugs Authority (RFDA). The system is rapidly maturing, characterized by strong alignment with EAC (East African Community) harmonization and WHO standards. It places a heavy emphasis on electronic reporting tools like VigiFlow and the Med Safety App.

1. Clinical Safety (Clinical Trials)

Clinical trials are strictly regulated under Law No. 48/2017 and require RFDA authorization.

• Expedited Reporting: Sponsors must report Suspected Unexpected Serious Adverse Reactions (SUSARs) aligned with ICH E2A standards:

  • Fatal or Life-Threatening: Within 7 calendar days.

  • Other Serious Unexpected: Within 15 calendar days.

• Periodic Reporting: Development Safety Update Reports (DSURs) are mandatory annually (ICH E2F format), particularly for ongoing trials.

• Oversight: Sponsors are responsible for insurance, causality assessment, and communication with the RFDA and Ethics Committees.

2. Post-Marketing Pharmacovigilance

Post-approval requirements are rigorous, requiring local presence and strict reporting timelines.

• Personnel: A Local Responsible Person (LRP) is mandatory. This individual must be a qualified pharmacist or physician residing in Rwanda and registered with the RFDA.

• Documentation: A Pharmacovigilance System Master File (PSMF) is required. While it does not need to be registered, it must be maintained and available for inspection.

• Incident Reporting (ICSRs):

  • Serious Cases: Report within 15 calendar days.

  • Non-Serious Cases: Report within 90 calendar days.

  • Foreign Cases: Serious unexpected cases relevant to Rwanda must be reported within 15 days.

  • Tools: Reporting is primarily electronic via VigiFlow or the Med Safety App.

• Risk & Periodic Reporting:

  • PSURs: Submitted in ICH E2C(R2) format. Typically required every 6 months for the first 2 years, then annually.

  • Risk Management Plans (RMPs): Required for new entities, biologics, and high-risk products. Must include a Rwanda-specific annex.

Summary of Requirements

Component	Requirement in Rwanda
Regulatory Authority	Rwanda Food and Drugs Authority (RFDA)
Local Personnel	Mandatory LRP (Pharmacist/Physician)
PSMF	Required (Maintained locally)
SUSAR Reporting	7 days (fatal) / 15 days (other serious)
ICSR Timelines	15 days (serious) / 90 days (non-serious)
RMPs	Mandatory (with Rwanda Annex)
Reporting Tools	VigiFlow & Med Safety App