The Working Group envisions that all manufacturers of pharmaceutical products will harmonize their practices regarding Core Safety Information (CSI) that their internal, central Core Data Sheets must contain. As introduced by CIOMS Working Group II, on periodic safety update reporting, CSI consists of the minimum essential information that a manufacturer requires to be listed in all countries where the drug is marketed; it excludes extraneous or inadequately substantiated information. It is believed that the principles and guidelines proposed by the Working Group for the inclusion of CSI in core data-sheets and its modification will lead to application of consistent decision rules on its content, to the use in common of standard terms and definitions, and a standard format for the placing of information in different sections of datasheets, and to adherence to valid criteria for timely and accurate revision.
The absence of internationally agreed standards for the format and content of information on pharmaceutical products for prescribers and other healthcare professionals is giving rise to discrepancies and inconsistencies from country to country and manufacturer to manufacturer. Therefore, the Working Group also envisions that national regulatory authorities will harmonize their basic requirements for safety information about medical products to be contained in their data-sheets, while it acknowledges the possible need for cultural differences reflected in different forms of medical and legal practice.
It is hoped that these proposals will form the basis of such harmonization. Since the standards proposed here will undoubtedly need continuous evaluation, updating and refinement, it is suggested that they be retained as guidelines and not adopted as regulations.
In an increasingly global regulatory and information environment, the Working Group foresees that widespread adoption of its suggestions will be of benefit to all by:
- minimizing confusion among prescribers and other health-care professionals due to inconsistencies between the drug-safety information of different countries and manufacturers;
- facilitating access to important information for making rational clinical decisions; and
- eliminating the diversity of national alert/expedited reporting requirements of different regulators, which result from differences in what constitute unexpected (“unlabelled”) adverse drug reactions.