Single Document Module: Structured Product Labeling (SPL)
Single document drug product submission modules are found in Canada, Japan and the United States. The SPL being one such example.
i4i is the world leader in providing SPL solutions. It has, since the beginning of SPL in 2004, worked with the FDA and industry on developing the SPL specification and building software to realize its implementation.
Structured templates are available to author the over 40 SPL submission types, including establishment registration, product labeling documents, medical devices and lot distribution. Content such as product data elements and establishments can be edited through specialized wizards with the web-browser interface and can be reused in multiple documents. Our SPL solution allows authors to instantly validate SPL documents against FDA requirements and generate SPL–compliant submissions.
Multi Document Module: EU Labeling Services
Multi document drug product submission modules are found in jurisdications such as the EU and the EMEA.
The creation of documents required by the EMA for EPAR is fully supported in ALiCE. A product definition is created to start the EU labeling process, which is used to automatically generate the required Quality of Review Documents (QRD), such as the SmPC and PL. Document variables are managed separately from the QRDs, which allows a consistent vocabulary between documents. Intelligent reuse and applicability models keep redundancy in authoring and translations to a minimum.
Common Data Services: Identification of Medicinal Product (IDMP)
ALiCE also provides services to manage IDMP data for EU submissions within QRD documents such as the SmPC. This data can be automatically identified for extraction from existing QRD documents, or marked up during the authoring process. Reports showing the available IDMP data can be generated to evaluate the completeness of an IDMP submission.
**IDMP will continue to evolve as Health Authorities begin to adopt the standards.