Quote from VigiServe Admin on November 28, 2020, 5:57 AM

In Tanzania, the pharmacovigilance system is regulated by the Tanzania Medicines and Medical Devices Authority (TMDA). It is one of the strongest systems in East Africa, aligned with EAC (East African Community) harmonization, WHO standards, and ICH principles.

1. Clinical Safety (Clinical Trials)

Clinical trials require TMDA approval and adherence to ICH GCP and EAC guidelines.

• Expedited Reporting: Sponsors must report Suspected Unexpected Serious Adverse Reactions (SUSARs).

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

  • Other Serious Unexpected: Within 15 calendar days.

• Periodic Reporting: Development Safety Update Reports (DSURs) are required annually.

• Submission: Electronic via Med Safety App or TMDA forms.

2. Post-Marketing Pharmacovigilance

• Personnel & Infrastructure:

  • Local Responsible Person: Mandatory. A qualified professional (pharmacist/physician) resident in Tanzania must be appointed as the primary contact.

  • PSMF: Required. A Pharmacovigilance System Master File must be maintained and available for inspection.

• Incident Reporting (ICSRs):

  • Timelines:

    • Serious: Within 15 calendar days.

    • Non-Serious: Within 90 calendar days.

• Risk & Periodic Reporting:

  • PSURs: Mandatory (Frequency: typically every 6 months for the first 2 years, then annually).

  • RMPs: Mandatory for new chemical entities, biologics, and high-risk products (EU format with local annex).

Summary of Requirements

Component	Requirement in Tanzania
Regulatory Authority	TMDA (Tanzania Medicines & Medical Devices Authority)
Framework	Act 2003 / EAC Harmonized
Local QPPV / PSMF	Yes (Local Resp. Person) / Yes
Safety Reporting	15 days (Serious) / 90 days (Non-Serious)
Clinical Reporting	SUSARs (7/15 days)
Submission Language	English