Authoring and Translation in the Life Sciences

This article was published in ISTC Communicator magazine Spring 2010.

One such standard is the Product Information Management (PIM) system, an XML-based platform for exchange of product information in the context of marketing authorization applications - the first step to being able to market a product in Europe.

Introduced by the European Medicines Agency (EMA) in December of 2005, PIM was designed to increase the efficiency of the management and exchange of product information (Summary of Product Characteristics, package leaflet and labeling) by all parties involved. This electronic exchange of information was developed to improve the quality and consistency of product information, by re-using common content globally and obviating the need for paper documents or materials in Microsoft Word formats - the process used to date.

A similar system - Structured Product Labeling (SPL) - exists for the United States. The purpose, as with PIM, is ‘to facilitate the review, editing, storage, dissemination of, and access to product labeling document content.' One major difference between PIM and SPL is that whereas SPL is designed to facilitate the provision of information, PIM was developed primarily to facilitate the exchange of information.

The PIM system has a very direct bearing on the translation industry - as its objective is to ensure that information in all official languages of the European Union is consistent and accurate. In particular, PIM makes it easier to carry out the simultaneous submission and review of the 20+ languages to agencies that are part of the EMA.

This is why PIM is an important part of EMA's Centralised Procedure (CP), which is the procedure for authorization of medicinal products, characterized by a single application, a single evaluation and a single authorization allowing the marketing of products in the single market of the European Community.

Corporations looking to gain approval for marketing of their products into countries recognized by the EMA must have the information surrounding SPC, package leaflet and labeling translated into its local languages. From the outside this task seems simple enough, however, a more microscopic view would reveal that this process is complicated, involves many stakeholders, and allows only a limited window of time for the content to be translated. This complexity can be appreciated even more when we take into consideration that one simple drug may give rise to over 900 labels when indications, strengths, and formulation, among other parameters, are factored in.

One of the key questions to answer when using PIM systems occurs early on during the authoring stage. The question faced by corporations is to determine whether the source document should be written in the traditional Word format using the standardized Quality Review of Documents (QRD) templates or in the XML format which is more compatible with the XML format of PIM.

Some suggest that authors can generate the document in Word and later convert to XML prior to conversion to PIM. As it relates to the translation process, it is important to note that translators will need to produce compliant documents for the review. If XML formatting is used for the authoring, then translators will need to be properly trained on the XML editor - a task that can be daunting for some. If Word is used as the authoring template, then one must ensure that the translated document is properly manipulated back into the PIM standard.

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