Essential tools when translating patient-facing drug information (PILs or SmPCs)

Writing and translating patient-facing material is highly regulated to ensure that medicines and medical devices are used correctly. The European Medicines Agency (EMA) is the body responsible for regulating the use of medicines in the European Union and its website is the most important tool for translators and other linguists when translating this type of documents.

For pharmaceutical companies, obtaining the marketing authorisation for a medicine is a highly complex and lengthy process. Delays at any stage can prove costly and must be avoided at all stages including during one of the final stages when translating product information documents (e.g. the PIL and SPC). To reduce possible discrepancies and to harmonise patient information across European Union countries, the EMA has drawn up a series of templates that have to be used for these documents, available here: https://www.ema.europa.eu/en/human-regulatory/marketing-authorisation/product-information/product-information-templates. They are available in 24 languages and vary depending on the marketing procedure (central or non-central –national, decentralised or mutual recognition). Some standard statements are given which must be used whenever applicable; we are all very familiar with them: “Keep out of the reach and sight of children”. Failure to comply with these templates can lead to delays and hence economic losses for the company.

Another important document available on the EMA website is the Quality Review of Documents template (EMA QRD) which refers to the correct style and layout of the PIL/SPC (font size, margins, paragraphs, etc.). It is available at:  https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/quality-review-documents-qrd-convention-be-followed-european-medicines-agency-qrd-templates_en.pdf and again the translator should followed these instructions if asked to by his/her client.

Regarding dictionaries and terminology, the most useful for medical terms, especially when listing side effects or adverse events (section 4.8 of SPC) is the Medical Dictionary for Regulatory Activities (MedDRA). This contains highly specific standardised medical terminology to facilitate the sharing of regulatory information. Subscription is necessary and training on use is available here: https://www.meddra.org/. An increasing number of pharma companies are using this for the product information. The aim is to harmonise nomenclature across languages.

The exact terminology for the pharmaceutical form is also strictly regulated. Which is correct “solution for injection”, “injectable” or “injection solution”? For this we turn to the European Directorate for the Quality of Medicines and HealthCare (EDQM) of the Council of Europe which among its other tasks works towards developing standard terms for use in marketing-authorisation applications and in the product information, to ensure that the wording used is standardised across medicines and can be easily understood by the target audience, such as patients and prescribers: https://standardterms.edqm.eu/

So before you begin the task of translating or revising any patient information, visit the EMA website and become very familiar with their templates!