Pharmacovigilance EVMPD

The New Pharmacovigilance Legislation (1235/2010) aims to safeguard the EU patients in a harmonized manner. However, for a very long time the medicinal product have been registered across the EU by individual National agencies. Moreover, various companies have applied for similar products, but have resulted in different product information and different specifications for batch release. More often than not, the product information was related to what could be reimbursed, causing country-specific indications. The introduction of the Mutual Recognition Procedure facilitated that for those countries selected, the product information was similar. However, not all countries have been selected for the same product. In addition, the Sunset Clause resulted in different product ranges across the countries. As a result, the products registered and the corresponding product information have diverted across the EU. This is not in line with the principles of the EU to have a single market and apply the same principles for public health. This legislation will contribute to harmonization, whether industry asked for it or not.

The first step is to capture all the adverse event reporting (ICSRs) in a single system that have to be associated to medicinal products as identified by a Eudravigilance Medicinal Product Dictionary (EVMPD). To populate and update the EVMPD, all Marketing Authorisation Holders have to submit the EVMPD data before July 2012. The submission format (XEVPRM) must be in compliance with a technical electronic protocol (XML Schema Definition). All the data must be gathered from various sources and the terminology used must be aligned across products and countries.

eCTDconsultancy offers the solution for pharmaceutical companies to meet the aggressive timelines. We do that by offering resources for preparing the XEVPRM submissions as well as recommendations on business processes, information flow and technical solutions. eCTDconsultancy is software independent and can cooperate with any software vendor for the technical side of the solution. This can be either company owned/ selected software or an independent vendor in a consortium with eCTDconsultancy and sister company Qdossier. Together these companies offer a one-stop-shop. A summary of the services is listed below.

Regulatory Services by eCTDconsultancy:

  • Project coordination and advice on:

    • Business processes, roles and responsibilities, and information flow and reuse of information concerning regulated information

    • Across company products, countries and disciplines

    • Across regulatory dossiers for clinical trial authorisations, marketing authorisations and EVMPD

  • Regulatory and strategic advice on terminology to be applied in electronic document and submission management.

Envisaged role of a Software Partner providing Information Technology Services:

  • Provision of software able to publish the XEVPRM submission (company implemented or SaaS environment) 

    • Including infrastructure for secure data exchange

    • Permission solutions to assure data confidentiality

  • Migration of existing Eudravigilance databases to XEVMPD

  • Building info hubs to reuse information from existing systems to populate the XEVMPD

  • Future development of the software to allow companies to maintain their own XEVMPD data and publish to the XEVPRM submission

  • Maintenance of user accounts for the EMA portal for XEVPRM submissions

  • Consultancy concerning the technical aspects concerning the above

Regulatory Operations Services by Qdossier (our sister company)

  • Human resources to extract information from various sources and entering into the XEVMPD database

  • Preparation of Module 3 baseline submissions to allow for optimal reuse of information across products and to facilitate efficient maintenance of changes


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