16 January 2012| Article by Dieter Schlaps
As of 2 July 2012, pharmaceutical companies which develop and market drugs in Europe will have to comply with the new standard, XEVMPD, when submitting medicinal product data to the European Medicines Agency, EMA. This will replace the current practice of multiple and duplicate submissions to the National Health Authorities and the EMA. Are you ready to tackle this challenge?

For many companies, the XEVMPD format constitutes a major organisational and structural challenge. A medicinal product submission adhering to the standards defined by the XEVMPD data model is a complex structure that entails various concepts (e.g. packaged product, pharmaceutical product, marketing authorization, manufacturer, clinical particulars etc.) with associated substructures and interdependencies. Typically, the information is only available in the repositories of the affiliates and must therefore be collected for a centralised submission.

The complexity and multidisciplinary character makes it difficult, if not impossible, to generate the data from existing data repositories to create the XEVMPD datasets. Furthermore, it might be difficult to find people able to verify the XEVMPD data. In other words, a new method is required in order to stay in compliance by 2 July 2012.

The Graphical XEVMPD-editor
To help life science businesses overcome this challenge and comply with EMA’s requirements, NNIT and its partner MAICOM have developed a software solution consisting of an editor and a validator that allows for immediate collection of XEVMPD data and submission in the proper format. The editor has efficient data entry features, such as constrained pick lists taking account of interrelations with an associated concept, or look-ahead typing functionalities proposing terms, controlled vocabularies etc.

Selected XEVMPD-editor features and benefits:

• Integrated field value constraints allow a simplified and accelerated data entry process.
• Multiple products, substances and relevant business objects are displayed simultaneously.
• Data are validated with a single click. The validation window helps to easily identify errors and correct them.
• Data is sent to EMA’s Gateway via the integrated Submission-Gateway.

Prospective as well as retrospective adherence
All medicinal products marketed in the EU are to be submitted in the XEVMPD-format. This implies that active drugs submitted prior to July 2012 must be re-submitted in order to comply with the legislation. This constitutes a major challenge and a considerable workload for many companies. Apart from collecting the required data for new registrations and for the continuous updates of medicinal product information, the editor will efficiently help process the considerable workload related to the handling of already submitted medicinal product information prior to the XEVMPD requirement.

Delivered as SaaS
NNIT’s graphical editor is delivered as a Cloud solution hosted in a GxP environment. It can be set up with or without an integrated database, storing the data on the local company storage. Users access with a Secure Login via HTTPS. The scalable solution is charged according to usage intensity which ensures an economic investment.

If interfaces to existing databases are necessary, we recommend using our database version. This is also the proper set up if the company has a large number of products, globally distributed product information and/or internal databases that need to be integrated by means of interfacing or migration.

Turn obligation into advantage
The rationale behind the XEVMPD requirement is ultimately protection of the consumer and improved patient safety. Therefore, EMA also demands more detailed information. With all data available within a single authority the management of medicinal product information becomes more standardised and transparent.

Once the XEVMPD software is implemented and the process is consolidated in the organisation, the new standard might actually pose an advantage as only a single authority has to be approached when submitting, as compared with today where both local and national health care authorities must receive the medicinal submissions. Features such as the accelerated data entry process and control functions in the graphical editor and validator help speed up the process and optimise the quality of the submission data, thus reducing the risk of recalls.

Contact NNIT for more information
If you would like to know more about how NNIT can help you adhere to the XEVMPD and turn obligation into advantage you can contact Service Area Lead, Integrated Drug Regulatory Affairs Dieter Schlaps on +49 1629 372 972.