Regulatory Requirements
Explore all topics, guides, and frameworks related to Regulatory Requirements.
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3- EU QPPV Requirements Summarises regulatory expectations for Qualified Persons Responsible for Pharmacovigilance (QPPVs) in the EU, covering the legal basis (Directive 2001/83/EC, Regulation 726/2004, GVP), requirement to appoint a QPPV, oversight of delegated activities, continuous availability, PSMF relationship and inspection roles. Read Article →
- UK QPPV Requirements Summarizes responsibilities and expectations for UK Qualified Persons Responsible for Pharmacovigilance: when a UK QPPV is required, oversight duties, availability and deputy arrangements, MHRA inspection involvement, and relationship with the PSMF. Read Article →
- How Often Should a PSMF be Reviewed? Regulations don't mandate a fixed PSMF review interval. Organisations should update the PSMF promptly after significant changes (QPPV appointment, deputy changes, vendors, safety database updates, restructures, inspection findings) and may perform formal periodic reviews (quarterly, semi‑annual or annual). Inspectors expect the PSMF to reflect actual practice; treat it as a continuously maintained living document. Read Article →