Worldwide Clinical Safety Reporting Regulations

This chapter summarises the diversity of current regulatory reporting requirements, pre- and postmarketing, for expedited and periodic safety update reporting, many of which purport to be based on existing harmonisation initiatives. It is hoped that the plea for improved harmonisation will be heeded.

The CIOMS V report was published during the second quarter of 2001 (CIOMS, 2001). It is of note that in February 2002 the ICH Steering Committee agreed to launch two new topics: the development of a further guidance on PSURs which will be an addendum to the existing E2C guideline, and a guidance on Good Case Management Practices which will be a follow-up of the E2A guideline. Both will consider the CIOMS V recommendations for incorporation and are expected to reach Step 2 in September 2002.

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