Q.01

What is CIOMS used for in pharmacovigilance?

In pharmacovigilance, CIOMS (the Council for International Organizations of Medical Sciences) matters in two ways. It gives you the CIOMS I form for individual adverse-reaction reports, and its numbered Working Group reports supply many of the terms, definitions and report formats that the ICH safety guidelines and national regulators use. The CIOMS I form is now mainly a fallback: under the current ICH E2D(R1), reports go electronically in the ICH E2B format, and CIOMS I is used only where E2B is not yet in place.

1. Reporting individual cases (the CIOMS I form)

  • ICH E2A (the clinical-trial safety guideline) says "The CIOMS-I form has been a widely accepted standard for expedited adverse event reporting." It adds that whatever format is used, certain basic data elements should be included. Its list of key data elements builds partly on CIOMS-I [1].
  • The original ICH E2D (post-approval reporting) used the same wording. It also recommended MedDRA coding and electronic submission under ICH E2B/M2 [2].
  • The revised E2D(R1) (2025) states that individual case safety reports (ICSRs) "should be transmitted electronically using the ICH E2B format". Only "in regions or countries where ICH E2B has yet to be implemented" may other formats such as CIOMS I be used [3].
  • Mexico's COFEPRIS mentions a CIOMS-to-ICH E2B transfer format as one of the technical documents it shares with marketing authorisation holders moving to electronic reporting [4].

2. Periodic and development safety reports

  • ICH E2A names the CIOMS-1 and CIOMS-2 Working Groups, on expedited (alert) reports and periodic safety update reporting, as "important precedents and models" [1].

  • The Development Safety Update Report in ICH E2F draws on the CIOMS Working Group VII report (Geneva 2007). Its glossary takes definitions from CIOMS VI and VII:

    • "adverse event of special interest" (CIOMS VI);
    • "data lock point" (CIOMS VII);
    • "completed clinical trial" (CIOMS VII).

    [5]

  • The Periodic Benefit-Risk Evaluation Report in ICH E2C(R2) uses terms from CIOMS working groups wherever possible. It points to CIOMS VII for example study synopses [6].

  • ICH E19 (selective safety data collection) uses the CIOMS VI definition of an adverse event of special interest [7].

3. Signal detection, planning and frequency categories

  • ICH E2E (pharmacovigilance planning) cites the CIOMS Working Group V report, "Current Challenges in Pharmacovigilance: Pragmatic Approaches" [8].
  • COFEPRIS signal-management material cites the CIOMS Working Group VIII report on practical aspects of signal detection [9].
  • COFEPRIS's manual on adverse events after vaccination uses the CIOMS frequency categories for adverse drug reactions [10]:
CIOMS categoryFrequency
Very common≥1/10 (≥10%)
Common≥1/100 and <1/10
Uncommon≥1/1,000 and <1/100
Rarethe scale continues to lower bands
  • A COFEPRIS safety bulletin cites the CIOMS III/V guidelines on core clinical-safety information [11].

4. Glossaries, benefit-risk and ethics

  • ICH M14 cites the CIOMS Cumulative Pharmacovigilance Glossary (Version 1.1, 2021) [12].
  • The ICH E22 draft names CIOMS XI and XII (benefit-risk balance; patient involvement) as useful outside resources. It also says they are not formally endorsed in that guideline [13].
  • The ICH M11 protocol template lists the CIOMS International Ethical Guidelines as one basis for trial conduct [14].

Approach: I searched the ICH E and M series guidelines, COFEPRIS pharmacovigilance publications, Belgian FAMHP pharmacovigilance guidance and India's Pharmacovigilance Programme publications. Neither the FAMHP nor the Indian sources mentioned CIOMS, and I did not consult the CIOMS reports themselves.

Q.02