Rationale

It is well established that continuous ADR surveillance is critical to assuring the safety of approved drugs in clinical practice. Prior to 1984, regulatory authorities restricted their requirements for the receipt of individual ADRs to domestic reports only. However, between 1984 and 1987 the United Kingdom, France, the United States, Italy and Germany introduced regulatory requirements for the submission of foreign reports. That is, manufacturers were required to report ADRs occurring in one country to the regulatory authorities in other countries where the drug was also marketed. As each regulatory authority had different requirements regarding time frames, formats and definitions, and were concerned about different types of ADRs, manufacturers were confronted with many problems.

The purpose of the CIOMS I working group was, therefore, to develop an internationally acceptable reporting method so that manufacturers could report post-marketing ADRs rapidly, efficiently and effectively to regulators.

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