Quote from VigiServe Admin on February 8, 2026, 1:45 AM

In Lesotho, Pharmacovigilance is regulated by the Lesotho Medicines Regulatory Authority (LMRA) under the Ministry of Health. The system is basic and functional, aligning with WHO minimum standards and regional SADC (Southern African Development Community) harmonization rather than rigid national legislation.

1. Clinical Safety (Clinical Trials)

Clinical trials are rare but strictly regulated when they occur, requiring LMRA and ethics approval.

• Expedited Reporting: Sponsors are expected to report Suspected Unexpected Serious Adverse Reactions (SUSARs). While not codified in a specific act, the expectation aligns with international (ICH E2A) and SADC norms:

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

  • Other Serious Unexpected: Within 15 calendar days.

• Periodic Reporting: Development Safety Update Reports (DSURs) or annual safety updates are typically required for ongoing trials (ICH E2F format).

• Submission: There is no dedicated electronic portal. Reports are submitted directly to the LMRA/Ministry of Health via email or hard copy.

2. Post-Marketing Pharmacovigilance

Post-approval surveillance is minimalistic, relying on national coordination and spontaneous reporting from healthcare professionals.

• Governance: The National Pharmacovigilance Centre (NPC) is operated by the LMRA. It collects data and contributes to VigiBase (via VigiFlow).

• Personnel & Infrastructure:

  • No Local QPPV: There is no requirement for a local Qualified Person for Pharmacovigilance residing in Lesotho.

  • No PSMF Mandate: Marketing Authorization Holders (MAHs) do not need to register or maintain a Pharmacovigilance System Master File in the country.

• Incident Reporting (ICSRs):

  • Reporting is spontaneous and voluntary.

  • Timelines: Not rigidly codified. The expectation is "prompt" reporting for serious or unexpected events (generally interpreted as 15 days).

• Risk & Periodic Reporting:

  • PSURs: Not routinely mandatory. Safety updates may be requested during registration renewal or for specific concerns.

  • Risk Management Plans (RMPs): Not a standard requirement; risk assessment is reactive and often linked to public health programs (e.g., HIV/TB).

Summary of Requirements

Component	Requirement in Lesotho
Regulatory Authority	LMRA (Lesotho Medicines Regulatory Authority)
National Centre	National Pharmacovigilance Centre (NPC)
Local QPPV / PSMF	Not required
Safety Reporting	Spontaneous; "Prompt" reporting expected
Clinical Reporting	SUSARs (Expedited); DSURs (on request)
Regional Alignment	SADC / WHO