Incorporation In Regulations

The CIOMS II proposals for periodic safety updates were rapidly incorporated into the European Draft Notice to Applicants but with a few significant modifications, including the concept of a European rather than an international birth date. This effectively implied that periodic safety reports currently scheduled to the IBD had to be rescheduled to the first European approval date—a step away from the vision of harmonisation. A European schedule for the frequency of submission was also included which stated that six-monthly reports were required for the first two years after approval, followed by annual reports for three years and then five-yearly thereafter. As individual countries began to implement their own periodic safety update requirements they requested this schedule based on their own local approvals. The scope of CIOMS II was also expanded to include all marketed products, not just those approved in or after 1992.

Before the European requirements could be finalised, ICH E2C adopted many of the CIOMS II principles in the Clinical Safety Data Management: Periodic Safety Update Reports for Marketed Drugs document that reached Step 4 in November 1996 (ICH, 1996). This included further modifications to the CIOMS II scope and format, including some reordering of the sections and introduction of new materials such as the summary tabulations to complement the line listing in section 6. Figure 25.2 shows the ICH E2C table of contents and highlights the changes from CIOMS II. There was also an additional requirement to explain to local regulators any differences between the local product information and the company core safety information.

Fortunately, ICH E2C reverted to the IBD for scheduling reports and the time for submission after the DLP was increased to 60 days. However, while this may be achievable for six-monthly reports, there is concern because the ICH E2C format is now being requested for periodic safety updates covering longer periods (including the five-year reports for local product renewals in Europe).

Currently, ICH E2C has been implemented in Japan and included in Volume IX of the Rules Governing Medicinal Products in the European Union—Notice to Marketing Authorisation Holders: Pharmacovigilance Guidelines. It is expected that the US Food and Drug Administration (FDA) will soon be introducing periodic reporting requirements based on ICH E2C.

In summary, the principles and guidelines proposed by CIOMS II achieved a harmonised approach to preparing periodic safety updates that

1. Introduction

2.* World-wide Market Authorisation Status

3.* Update on RA or MAH actions for safety reasons

4. Changes to reference safety information (new)

5. Exposure data

6.* Individual case histories (summary tabulations)

7.* Studies

8.* Other information

9.* Overall safety evaluation

10. Conclusion

Appendices-including CCSI

* ICH E2C amendments to CIOMS II

met most existing requirements in 1992. However, they were unable to forestall the diversity of future requirements following their incorporation into regulatory requirements around the world.

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