Pharmaceutical translations are no child’s play. Specialised terminology aside, the stakes are incredibly high in the case of a mistranslation – one simple error can have real-life consequences. For our pharmaceutical industry clients, we regularly translate documents destined for the European Medicines Agency (EMA) and the competent authorities of the EU Member States. When it comes to the EMA, which is responsible for the evaluation and supervision of human and veterinary medicines within the EU, there are certain aspects to bear in mind. In this article, we outline the top things to watch out for.
QRD framework
Most importantly, pharmaceutical documentation submitted to the EMA must follow approved Quality Review Document (QRD) templates. At the heart of it, these comprise a summary of product characteristics (SmPC), patient information leaflet (PIL), and label. The templates differ depending on:
- whether the drug is question is intended for humans or animals;
- whether the drug is being submitted for approval within a centralised procedure (CP) or decentralised procedure (DCP);
- if for DCP, which EU market the files will be distributed in.
It’s important to follow the standard wording of these templates. Headers, for example, should mirror the exact wording used within the national templates. You also need to keep abreast of any updates. Failing to use the latest product information template runs the risk of the files being rejected.
Formatting is dictated by the QRD conventions. Text must be left aligned (except for title pages), bullet points should have a one-cm indent, the font used must be Time New Roman size 11, and so forth. Formatting might seem a minor detail – but trust us, you risk the EMA rejecting your submission if you fail to respect the rules!
Different strokes for different folks
Certain elements of the documents are country-specific. Take, for example, text on adverse reporting (ADR), which can be found in Section 4 of the PIL and Section 4.8 of the SPC. This calls for particular care because a patient in, say, Sweden would need to report any adverse side-effects to the Swedish Medical Products Agency. In turn, someone in the Netherlands would need to get in touch with the Netherlands Pharmacovigilance Centre (Lareb). You need to make sure you are entering the correct contact details for each country. Indeed, every EU nation has its own dedicated agency for this very purpose.
The Norwegian Medical Products Agency, meanwhile, stipulates package leaflets for human medicinal products must include the URL for the Norwegian Pharmaceutical Product Compendium (Felleskatalogen). The Dutch agency attaches great importance to using simple, patient-friendly wording in the package leaflet. And the Danish Medicines Agency (DMA) is keen on the differentiating the terminology used for the PIL (patient-friendly) and SmPC (oriented toward healthcare professionals).
Then, of course, a marketing authorisation holder may propose to call one and the same product a different name in each different language. This is where the Annex 5.19, a list of invented names, comes in – linguists must refer to this list when translating the product name and cannot simply come up with their own version. In other words, EMA translations need to be adapted to the requirements and preferences of each market.
A race against the clock
When it comes to timelines, EMA translation projects can be subject to immense time pressure. This is notably the case when it comes to ‘End of Procedure’ (EoP, final opinion) for centralised procedure submissions. Here, the marketing authorisation holder is usually granted five days – weekends included – to implement the EMA’s very last amendments to all 24 language versions. With this in mind, having a reliable and reactive translation provider at your side is an absolute must.
How First Edition can help
At First Edition, we understand that medical translation requires a high level of skill, expertise and precision. We have amassed over 40 years of experience in the trade, working with highly skilled specialist translators covering over 30 world languages. Simply email our multilingual project management team at enquiries@firstedit.co.uk to discuss how we can support you.