CIOMS in Pharmacovigilance in 2026: Forms and Guidance

CIOMS in Pharmacovigilance in 2026: Forms, Working Groups and Practical Use

Updated 15 July 2026. The Council for International Organizations of Medical Sciences (CIOMS) develops international scientific recommendations for pharmacovigilance. CIOMS work influenced ICH guidelines E2A, E2C, E2D and E2F, but CIOMS recommendations do not normally replace binding national or regional requirements.

What is the CIOMS I form?

The CIOMS I form was developed to standardise reporting of individual suspected adverse drug reactions. It helped establish a minimum case-data set and became the basis for many national reporting forms.

• an identifiable patient;
• an identifiable reporter;
• a suspected medicinal product;
• a suspected adverse reaction;
• relevant concomitant medicines, medical history, outcome and case assessment.

Important: CIOMS I is not a universal regulatory submission method. Many systems require electronic ICSR transmission using ICH E2B(R3). MAHs must follow the format, route and timelines required by the competent authority in each jurisdiction.

Major contributions of CIOMS working groups

• CIOMS I — international adverse-reaction reporting and the standard form.
• CIOMS II — periodic safety summaries that influenced the PSUR.
• CIOMS III/V — core clinical safety information.
• CIOMS VI — management of safety information from clinical trials.
• CIOMS VII — the Development Safety Update Report (DSUR).
• CIOMS VIII — practical approaches to signal detection.
• CIOMS IX — risk minimisation for medicinal products.
• CIOMS X — evidence synthesis and meta-analysis for drug safety.
• CIOMS XI — patient involvement in development, regulation and safe use of medicines.

What is current in 2026?

• The Working Group XIV report on artificial intelligence in pharmacovigilance was published in December 2025. It addresses automated and semi-automated processes alongside quality management and human oversight.
• Version 2.4 of the CIOMS Cumulative Pharmacovigilance Glossary was published in 2026 and covers terms from 18 CIOMS reports issued between 1992 and 2025.
• Working Group XVII is developing approaches to long-term safety of medicinal products throughout their lifecycle.

Practical checklist for MAHs

1. Identify applicable binding requirements and do not substitute CIOMS guidance for local law.
2. Confirm whether the authority requires a paper form or electronic ICH E2B(R3) transmission.
3. Ensure the four minimum criteria for a valid ICSR and document follow-up.
4. Align terminology across SOPs, the PSMF, safety database and agreements with current definitions.
5. For automation and AI, establish validation, quality control, decision traceability, data protection and human oversight.
6. Train employees and partners to recognise and promptly forward safety reports.

Official sources

• CIOMS: Pharmacovigilance
• CIOMS: history of pharmacovigilance working groups
• CIOMS Cumulative Pharmacovigilance Glossary, version 2.4
• CIOMS Working Group XIV: Artificial Intelligence in Pharmacovigilance

How PharmExpert can help

PharmExpert helps organisations develop ICSR procedures, implement ICH E2B(R3) data exchange, update SOPs and the PSMF, train personnel and prepare pharmacovigilance systems for audits and inspections.

This article is for general information. Regulatory submissions must follow the current requirements of the competent authority in the relevant jurisdiction.