Frontier Translation

To save time clicking around, a list of direct links to EPAR summaries for the public can be retrieved from Google using a search expression like:

“EPAR summary for the public” filetype:pdf site:ema.europa.eu

The results can be filtered by date, either using the “Custom Date Range” feature on the results page, or by going directly to a URL such as the following:

http://www.google.com/webhp?hl=en#q=”EPAR+summary+for+the+public”+filetype:pdf+site:ema.europa.eu&hl=en&tbo=1&site=&output=search&source=lnt&tbs=qdr:m

Note the qdr:m parameter, which indicates that results should be limited to new content from the past month

My contact at the pharmaceutical translation agency in Germany has passed along a link to the European Medicines Agency’s templates for product information concerning human medicines. The EMA is a decentralized agency of the European Union, and is responsible for the the scientific evaluation and supervision of human and animal medicines. The templates have been developed by the The EMA’s Working Group on Quality Review of Documents (QRD).

I’ll share that link — and you can guess what I’ll be studying next:

EMA product information templates

The scope of the QRD’s work is as follows:

The Working Group on Quality Review of Documents (QRD) provides assistance to the European Medicines Agency’s scientific committees and to companies on linguistic aspects of the product information for medicines. This includes summaries of product characteristics, labelling and package leaflets.

The QRD’s tasks include:

• ensuring linguistic clarity, consistency and accuracy of the product information;
• verifying the terminology used in translations and their consistency with the original versions;
• promoting legibility of product information;
• reviewing and updating templates for opinions of the scientific committees and for product information, to ensure compliance with European Union (EU) rules on medicinal products and taking practical experience into account;
• contributing to the development of a common understanding on the implementation of legislation and guidelines in relation to product information and labelling

Two links from the product information templates page stand out as being of particular interest to translators:

• List of standard terms for pharmaceutical dosage forms, routes of administration and containers
• Interinstitutional style guide

Three things are of particular interest with respect to QRD’s oversight of product information:

• Linguistic review process
• List of standard terms for pharmaceutical dosage forms, routes of administration and containers
• Interinstitutional style guide

Examples of product information can be found uder the Find Medicines section of the EMA’s website. The product information includes a summary of the product’s European Public Assessment Report (EPAR), and the full text of the EPAR. The summary is intended for the general public.

Under the human medicines section, there are currenly 773 products listed. That relatively small number is due to the fact that the EMA only deals with medicines which have been referred to it, due to some disagreement between member states. It’s such a small number that conceivably a human being could read a reasonable fraction of the corpus within a few months, and thereby become a subject expert.

The structure of an EPAR consists of three Annexes:

• Annex I: Summary of Product Characteristics. This is the meat of an EPAR, containing approximately 125 pages of scientific information.
• Annex II A: Manufacturing Authorisation Holder Responsible for Batch Release, and Annex II B: Conditions of the Marketing Authorisation, containing a total of about 1 page of administrative information.
• Annex III A: Labelling, and Annex III B: Package Leaflet. The labelling section consists of short blurbs which are so simple as to almost not require human translation. If you skim Annex III A from a single EPAR, you’ve pretty much grasped the concept. The Package Leaflet section is of much more interest, but will contain several nearly redundant package leaflets, each running to approximately 5 pages.

It’s unclear how much of this material would require translation into English. The guidelines for the linguistic review process mention that “[a]t submission and during assessment, only the English language version (EN) of the product information is submitted and reviewed”. However, possibly German, Swiss, and Austrian drug manufacturers would prepare the first version entirely in German, and have it translated into English for submission.

An initial reading program related to EPARs could be carried out as follows: 1) sort the list of products in descending order of authorization/refusal date 1) read the entire EPAR for the first few products, 2) continue reading selected summaries and package leaflets.

A further skill to be developed would naturally be facility with British English, which is the official variant for use in EU agency documents.