Last week an agency asked me if I would write some instructions for their medical translators about using EMA-QRD templates in their work. I thought I would share my ideas with you.

First, let me clarify that I’m talking about the European Medicines Agency. The acronym EMA has been widely used, unofficially, since EMEA dropped the second E in its name two years ago (‘Evaluation’ was removed from its full title). Also, it tended to be confused with Europe, Middle East and Africa. Anyway, I’m all for using EMA, being true to my name!

QRD stands for Quality Review of Documents, which is a working group associated with the Committee for Medicinal Products for Human Use (CHMP).

The QRD templates on the EMA website give you the official wording that has to be used in the summary of product characteristics (SmPC), labelling (L) and package leaflet (PL) of medicinal products, in accordance with Directive 2001/83/EC. The aim is to ensure consistency across different medicinal products and across all Member States. The templates define:

• Standard headings (e.g. “CLINICAL PARTICULARS”)
• Standard statements and terms (e.g. “Keep this medicine out of the sight and reach of children”).
• The format and layout to be used (e.g. Times New Roman, 11 pt)

You can find the main template for the SmPC, L and PL at Product information: Regulatory and procedural guidance. Scroll down the page until you come to the QRD templates:

The main template is in DOC format. It’s a good idea to download versions in your source and target languages from the drop-down list, because then you can check that your source text complies with the template. If it differs, you need to go back to your client to ask whether you should follow the source text faithfully or keep to the template.

The appendices contain standard statements and terms for specific sections:

• APPENDIX I – Pregnancy and Lactation statements for the SmPC.
• APPENDIX II – Undesirable effects. The drop-down menu is bilingual here and each file is in English plus the selected language. This appendix uses the MedDRA frequency convention and system organ class database.
• APPENDIX III – Storage statements for the SmPC, L and PL.
• (Also, check out Appendix IV if you’re not sure how to translate “batch” and “expiry date” in your target language.)

Some of these documents make use of Word’s track changes to highlight the latest updates in these versions.

Now scroll further down the same page until you reach the QRD Guidance section:

There are three (English-only) documents that are particularly relevant for translators. I’ve circled them in the screenshot above.

1.    QRD convention. This short PDF gives specifications regarding font, font size, page layout, etc. Check that your source document follows these specifications and if it doesn’t, I would recommend adapting your translation to these requirements. (Again, you may want to check this with your client). It also explains the bracketing convention, although of course you shouldn’t find any of these brackets in the final text.

• {} = Information to be filled in
• <> = Text to be added or deleted
• [Green text] = Guidance and explanatory notes only.

2.    QRD decisions on stylistic matters. This is a tabulated list of linguistic problems that have been identified and solved. It covers the use of abbreviations, gender issues, number formats, spaces between figures and units, etc.

3.    QRD decisions on use of terms. This is a short list of terminology problems, prohibited terms and controversial terms. Check out this file if you’re not sure whether to use excipients or ingredients; posology or dose; newborns or infants.

The EMA has also just published new versions of the controlled vocabularies used in Extended EudraVigilance product report messages. Use these Excel files when translating documents based on QRD templates if you need to confirm the standard terms for units of measurement, pharmaceutical dose forms, substances, etc.

To summarise, when you are asked to translate an SmPC, L or PL using the EMA-QRD templates:

1. Download the main template in your languages (I keep them on my second monitor when I’m translating). Check out the appendices.
2. Read the QRD guidance documents on formatting, style and terminology.
3. Use the standard headings, statements and terms in the template and the appendices.

Image attribution: raymaclean