Rationale

CIOMS II introduced the concept of the core data sheet. It is a document prepared by the pharmaceutical manufacturer, containing the minimum essential safety information, such as ADRs, which the manufacturer stipulates should be listed in all countries where the drug is marketed (see Figure 25.3). It is also the reference document by which "labelled" and "unlabelled" (or listedness and unlistedness for ICH E2C) are determined. Thus, it should focus on the important information required for rational clinical decision making and harmonise safety statements world-wide for public health and regulatory purposes.

The CIOMS III working group set out to propose principles and guidelines for consistent decision-rules on the content of the Core Safety Information (CSI), standard terms and definitions, and a standard format. One of the major concerns was to minimise confusion among prescribers and other healthcare professionals due to inconsistencies between the safety information presented in different countries and by different manufacturers.

Figure 25.3. CIOMS III—The vision.

Figure 25.2. ICH E2C—Table of contents.

Figure 25.3. CIOMS III—The vision.

It was therefore hoped that regulatory authorities would harmonise their basic requirements for safety information in their local data sheets. However, the working group acknowledged the possible need for cultural differences due to medical and legal differences.

The first edition of the CIOMS III report published in 1995 (CIOMS, 1995) focused on CSI for marketed products, including the initial CSI that is prepared in conjunction with the first market authorisation submission, review and approval. During CIOMS V discussions it was proposed that the same basic philosophy and practices be applied to the safety information provided to clinical investigators during a development programme. The concept of development core safety information (DCSI) as a discrete, focused section of the Investigator's Brochures, which would have the same format as, and would evolve into, the CSI at initial marketing of the product, was therefore agreed. A second edition of the CIOMS III report was issued in 1999 (CIOMS, 1999) including the new proposals for Investigator's Brochures.

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