Adherence to EVMPD & IDMP
(Article 57(2) of Regulation (EC) 726/200)
xEVMPD: Do you know the value of your data?
Have you been successful in submitting all or part of your data to the EMA using the free EVWEB-Tool? If so, ask yourself the question if there is more you can do with the data that you have already collected and submitted. By simply re-using your existing data you can:
- Receive an overview of your registration activity worldwide, including variations and PSURs.
- Understand the impact of a change in your product composition.
- Manage deadlines for agency correspondence.
- When re-submitting changes to EMA, batch update xEVMPD data if, for example, you have a new QPPV.
- Be ready for upcoming standards, such as ISO IDMP.
Background:
The European Medicines Agency (EMA) has been given a mandate by the EU Commission to build a database for all registered product information witin the European Union, updating the EudraVigilance Medicinal Product Dictionary (EVMPD). This is, according to the EMA itself, the biggest change to the regulation of human medicines in the European Union (EU) since 1995. It has significant implications for applicants and holders of European Union marketing authorizations.
The legistlation is in place and all companies that maintain products in the European Union, whether centralized, decentralized or national, have had to adhere to this requirement by July 2nd, 2012. Further information can be obtained from the EMA website.
The aggressive time schedule is a challenge to industry, but also to software vendors, that are expected to develop solutions within a quality-controlled environment in a very short period of time.
We too have looked into the new xEVPRM standard that will be used by the EMA, a standard that will ultimately be displaced by the ISO Identification of Medicinal Products (IDMP) standard. EMA plans to update the existing format to the ISO format by the end of 2016.
LORENZ complies with these requirements with drugTrack EVMPD. We will also support the ISO IDMP format when it comes into force. Companies can opt to upgrade this version of drugTrack to re-use the accumulated data to track the entire regulatory life cycle.