Rationale

This initiative was started in November 1989 at a time when several countries had requirements for periodic safety updates; however, individual local regulatory authorities were requesting that data (both foreign and domestic) be presented according to different inclusion criteria, formats and time intervals. Due dates were often determined by the national licensing approval date and therefore varied between individual formulations of the same drug substance. Preparation of these summarised safety updates had become a significant administrative burden for manufacturers. Figure 25.1 shows the report preparation schedule for a fictitious drug with different due dates and periods for review.

Figure 25.1. Report schedule for Qweasytrol.

The purpose of the CIOMS II working group was to explore the possibility of developing a harmonised approach to preparing periodic safety updates that would meet most existing needs and forestall any diversity in future requirements. It was also hoped that if the guidelines on this approach were adequate and reasonable other regulatory authorities would adopt them in the future. Standardisation would also enable pharmacovigi-lance staff to focus on reviewing the data rather than generating a battery of different reports.

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