Standard

The proposal is to create an exchange standard for the electronic product information (ePI), between pharmaceutical companies and regulatory authorities, taking as a reference the European Medicinal Agency (EMA). The first step is to focus on the Summary of Product Characteristics (SPC), other parts of the product information will be done later. The rationale is to have a usable standard in a few months.

It is an exchange data format standard with two main components:

Definition of the SPC

A document type definition (DTD) of the SPC structure: this is an indispensable component for any attempt at standardising the SPC, as proposed here or by other approaches. It largely consists of expressing as a DTD, the prose the relevant regulatory texts such as the Quality Review of Documents (QRD). Indeed, it is already mostly completed; the ongoing work is on refining the lower SPC children in the Extensible Markup Language (XML) tree.

Container format

A technique to pack documents: a zip file containing a specified directory structure and navigation friendly when unzipped (Xdossier).

Technology

The approach is to keep it as simple as possible, so to make it accessible to widest the audience, particularly non-IT experts as many participants come from other fields such as pharmacy or medicine. Only plain vanilla XML and Cascading Style Sheets (CSS) is used, avoiding more complex technologies such as namespaces and XSL. Documents are simple XML with CSS, no transformation to HTML; the only difference with a tree view of the same document is just the removal of the CCS, just one line at the top of the document.

Clerical staff should be capable of preparing product informations: offline just with a template and a basic editor such as Notepad. There should be no dependence on online systems, specialised bespoke systems, or even an XML editor. The choises for technology stack should minimise dependencies, such as from HL7 or others.

Multilingualism

The strategy is to generate all linguistic versions from text tables. Generation of Electronic Product Information (GePI) is a computer system that, among others, optimises how data is kept and processed; it stores a single copy of language neutral elements (e.g. ATC code) from which all linguistic versions are generated. The routinary works of filling the tables in most languages has to be finalised.

Data quality

With Ged, quality is inbuilt into the production process. In addition, the standard imposes the production of highly structured fine granularity datasets that facilitates cross-checking among languages and products. Some errors could be detected programatically, others would be easily spotted by humans when the data is presented in an appropriate fashion; for example, by showing all the language segments side by side.