This section specifies the Data Exchange Standard Specification (DES) for Product Information (PI) in the European Union (EU). In line with the general principles of the ICH eCTD Specification Document, it is intended that eXtensible Markup Language (XML) will become the submission format for product information documents, as they contain structured data. The long-term goal of this development is the Normalisation of data in Module 1 (Administrative information and product information). As the XML documents become available for practical implementation, they will be introduced into Module 1 and may be submitted either alongside or instead of the current file formats as specified by the agencies. The scope of PIM currently extends to the Centralised Procedure only.
This DES specification document is not restricted indefinitely to the Centralised Procedure only. Once MRP and National procedures define templates for the PI documents, they could be integrated in future versions of the DES.
Currently, the relevant product information should be provided as part of the eCTD Module 1 as files in a PDF and/or RTF format. MS Word is also a requested format.
A more effective way to transport and to handle product information is needed to reduce the effort required to produce and maintain the identical data included in the various documents and to facilitate the exchange of data between applicant and regulatory authority.
The exchange of Product Information using XML (PIM) will facilitate this process, and will aid the update and review process for the data throughout the product lifecycle.
Furthermore, applicants and regulators will gain benefits in the following areas:
- Reduction of time required for editing and review through the elimination of repetitive handling of the implicated data
- The automatic creation of consistent exchange files through data extraction from databases
- The automatic extraction of data from the exchange document into a database
- General improvement in the quality and consistency of Product Information presentation
A two-way exchange of document fragments that can be reliably and consistently integrated into comprehensive output documents.