M2: (ESTRI)-Electronic Standards for the Transfer of Regulatory Information

Regulatory Resource: M2: (ESTRI)-Electronic Standards for the Transfer of Regulatory Information

Description:

The lack of internationally harmonized standards related to core sets of medicinal product information and medicinal product terminology is hindering the scientific evaluation and comparison of product data as well as healthcare. This applies in particular to the area of pharmacovigilance, where the exchange and management of medicinal product information in expedited and periodic adverse reaction reports at the international level is a key aspect of ensuring drug safety.

This document provides guidance on the harmonized standards that are being proposed by the ICH M5 EWG to facilitate the exchange and practical use of medicinal product data by regulators and pharmaceutical industry.

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