Pharmacovigilance Guidelines: 2026 Overview

Pharmacovigilance Guidelines: Current Overview for 2026

Updated 15 July 2026. Pharmacovigilance requirements exist at several levels: national legislation, regional EAEU and EU rules, harmonised ICH guidelines, CIOMS recommendations and WHO materials. MAHs must follow binding rules in every jurisdiction where a product is authorised and use international guidance to build a consistent quality system.

Main groups of guidance

• EAEU GVP — pharmacovigilance systems, PSMF, QPPV, ICSRs, PSUR/PBRER, signals, RMPs, audits and inspections.
• EU GVP — Modules I–XVI and product- or population-specific considerations.
• ICH E2 — international standards for clinical and post-authorisation safety-data management.
• CIOMS — scientific guidance on case reports, signals, benefit–risk, risk minimisation, patient involvement and AI.
• WHO — national systems, international monitoring and medicine and vaccine safety.

Key ICH documents

• ICH E2A — expedited reporting of clinical safety data;
• ICH E2B(R3) — electronic transmission of individual case safety reports;
• ICH E2C(R2) — PBRER;
• ICH E2D(R1) — post-approval safety data management;
• ICH E2E — pharmacovigilance planning;
• ICH E2F — DSUR;
• ICH M14 — real-world data for post-marketing safety assessment.

What is current in 2026?

• EMA is applying amendments introduced by EU Regulation 2025/1466 and updating affected GVP modules.
• EU GVP considerations for pregnant and breastfeeding women and children exposed in utero or via breast milk became effective on 9 February 2026.
• ICH E2D(R1) and ICH M14 recommendations should be applied where they affect current GVP processes.
• For the EAEU, Decision No. 87 as amended and common pharmacovigilance inspection rules remain central.

Managing regulatory documentation

1. Maintain a register of applicable documents by product and country.
2. Assign process owners and a regulatory-monitoring frequency.
3. Assess each change against the PSMF, SOPs, agreements, databases and training.
4. Document the decision, implementation plan, deadlines and evidence of completion.
5. Verify consistency between global and local procedures.
6. Use current versions from official regulatory websites.

Official sources

• EEC: acts governing medicinal products
• EMA: Good Pharmacovigilance Practices
• ICH: Efficacy Guidelines E2A–E2F
• CIOMS: Pharmacovigilance
• WHO: Pharmacovigilance

How PharmExpert can help

PharmExpert provides regulatory monitoring, gap assessments, PSMF and SOP updates, personnel training and audit and inspection readiness support.

Guidelines are regularly revised. Always verify the current version on the competent authority’s official website before making a regulatory decision.