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NAFDAC QPPV & PV Compliance Readiness Assessment

Under NAFDAC's pharmacovigilance guidelines — reinforced by Nigeria's WHO ML3 status — Marketing Authorization Holders must maintain strict, continuous, in-country safety monitoring.

⏱ Takes ~2 minutes📊 Instant score & gap report🔒 No signup needed
Your details
1

Do you have a permanently resident, qualified QPPV physically located in Nigeria?

2

Do you have a formally designated deputy/backup QPPV in Nigeria to ensure continuous coverage?

3

Is there a named Local Safety Officer (LSO) or Local Contact Person for PV registered with NAFDAC?

4

Is your Pharmacovigilance System Master File (PSMF) fully localized and regularly updated for Nigerian operations?

5

Do you have an active, validated pathway for capturing and processing local Adverse Drug Reactions (ADRs)?

6

Do you conduct weekly literature monitoring across local Nigerian medical journals and news sources?

7

Are you actively tracking and submitting PSURs/PBRERs in alignment with NAFDAC regulatory cycles?

8

Have you submitted product-specific Risk Management Plans (RMP) or educational materials to NAFDAC?

9

Do you have a formalized process for safety signal detection and escalation of safety concerns in Nigeria?

10

Are your local PV SOPs and training records audit-ready for a surprise NAFDAC inspection?