China Pharmacovigilance and CIOMS: Building a Strong Framework for Drug Safety
CIOMS plays a crucial role in the field of pharmacovigilance by coordinating and publishing
guidelines on drug safety, working with representatives from the global biomedical scientific community. The
organization’s programs focus on key areas of biomedicine, including bioethics, health policy, ethics, human values,
drug development and use, and international nomenclature of diseases. Since the 1980s, CIOMS has been running
projects that address drug safety, and its working groups have published several guidelines for practice. These
guidelines are influential in shaping pharmacovigilance practice worldwide and are widely used, although they have
no legal or regulatory mandate. CIOMS also developed the CIOMS Form I, a standard format for reporting suspected
adverse reactions to medical products that has proved valuable in practice and is still widely used.
The organisation was founded by the WHO and UNESCO, the United Nations Educational, Scientific and
Cultural Organisation, in 1949. It is an independent not-for-profit body which is not affiliated to, or funded by,
any single government or nation. The organisation brings together representatives from the “biomedical scientific
community” worldwide, aiming to encourage and facilitate international biomedical scientific activities whilst
maintaining a relationship with the United Nations organisation (particularly WHO and UNESCO)
The CIOMS working groups have published a number of practice guidelines, including
I – Internatonal reporting form (also known as CIOMS I Form)
II – Periodic Safety Update Reports (PSUR)
III – Guideline for Preparing Core Clinical Safety Information (CCSI)
on Drugs
IV – Benefit-risk assessments for marketed drugs
VI – Management of Safety Information from Clinical Trials
VII – Development safety update reports (DSUR)
VIII -Signal Detection(Publication: Practical Aspects of Signal
Detection in Pharmacovigilance)
In addition, CIOMS was involved in publishing an initiative to standardise
the use of medical terms associated with adverse drug reactions. However,
this has not been widely accepted in pharmacovigilance practice.
