agXchange RSM™

electronic submission of regulatory data

The agXchange RSM (Regulatory Submissions Module) supports the submission of the EVMPD product data as requested by the EMEA. Initially supporting the submission of EVMPD data, agXchange/RSM can be easily extended to support the electronic submission of other regulatory data including SPL, PIM and eCTD documents, etc.

Since the initial announcement of the EVMPD initiative by the EMEA, the life sciences industry has questioned if and when the population of the EVMPD would become legislation. In 2005, the EU Clinical Trial Directive implied the population of clinical trial products (IMPs, DMPs) to be mandatory, but even this was unclear.

Volume 9A, published in draft in December 2005 seeks to clarify the requirements for population of the EVMPD for marketed products. In it, the guidelines state..."To permit the correct identification of medicinal products related to adverse reactions reported in line with the reporting obligations set out in Community legislation as well as data analysis and signal detection, the Agency and Competent Authorities request all Marketing Authorisation Holders to enter each medicinal product for which they hold a marketing authorisation within the EEA, in the EudraVigilance Medicinal Product Dictionary (EVMPD)"*

Predicting the need to support the EVMPD initiative in compliance with the proposed guidelines, Aris Global has released agXchange to support the submission of EVMPD data using an electronic gateway that can be integrated with any source of regulatory product information.

*Source: Volume 9A of the Rules Governing Medicinal Products for Human Use