Process

On the understanding that the CIOMS members would modify their own international reporting procedures accordingly, the working group set out to define what constituted a reportable individual reaction, the elements of a report and the procedure and format for submitting individual reports. As most reporting depends on legal requirements, it became clear that the regulators needed to reach consensus. When this had been achieved a pilot test was undertaken to demonstrate the feasibility and utility of standardised reporting. The effort was geared towards the international exchange of post-approval reports of suspected, unexpected (unlabelled) serious ADRs. The manufacturers in the working group reported local cases according to the domestic requirements in that country and then entered the cases on to single common forms and submitted them to the other regulatory authorities represented on the CIOMS working group. Reports received from a country outside the participating six were entered on a single report and submitted to all six regulators.

The advantages of standardisation to the manufacturers were that it avoided a multitude of different requirements from different regulators, eased communication of reports between international corporate affiliates, and lessened regulatory ambiguities. From the regulatory perspective, standardisation could improve standards and reporting compliance by manufacturers and facilitate the exchange of information between regulators.

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