EMA closes the circle between ICSR and XEVMPD by requiring the ISO IDMP´s controlled vocabularies also for ICSRs

The European Medicines Agency (EMA) has published a guide to support the implementation of a new international standard for the safety monitoring of medicines in the European Union (EU). The so-called ISO ICSR standard improves the reporting of suspected side effects of medicines in Individual Case Safety Reports (ICSRs). The use of the new international standard will take effect on 1 July 2016. EMA is herewith closing the circle between ICSR and XEVMPD by using the ISO IDMP´s controlled vocabularies. It requires the use of the new ISO IDMP standards when they become available for use in the EU.
The interesting part for closing the circle between XEVMPD and ISCR is the so called MPID – Medicinal Product Identifier – also part of IDMP standard ISO 11615 identifying the product with ist entire liefe cycle (development, authorisation, post-Marketing and renewal or withdrawal from the market. Further it is stated that ‘until such a time as the ISO IDMP standards are implemented worldwide the support for free text will be required.
However, when the circle will be closed, then the aim of IDMP to increase the patients´safety will be reached.

ISO ICSR aims to establish the same format for the reports on individual cases of suspected side effects in patients due to a medicine across the world. It also is expected to include better information on medicines that might be associated with an adverse drug reaction and on the therapeutic uses of those medicines. In addition, the standard also strengthens personal data protection in the records of ICSRs collected by pharmaceutical companies and regulatory authorities.

This will improve the quality of data collected, and increase the ability to search and analyse them. Regulatory authorities will be able to detect and address safety issues with medicines more quickly, and therefore better protect patients.

The new guide developed jointly by EMA and the Heads of Medicines Agencies (HMA) will be of interest to pharmaceutical companies and medicines regulatory authorities in EU Member States and will support them to prepare for the use of the standard. The guide specifically defines the electronic transmission process of ICSRs, the format and content of the ICSR, the business rules for report validation as well as classification and data quality principles. It will also assist software providers and IT developers as pharmacovigilance databases are being developed.
URL to the EU ICSR Implementation Guide

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