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There are a number of challenges facing translators specialising in Regulatory Affairs. The widespread use of acronyms/abbreviations and the need to keep abreast of the various regulations, directives and guidelines are two of the biggest. Attempting to translate Regulatory Affairs documents without at least some knowledge of the relevant guidelines/directives/regulations and commonly used acronyms could prove disastrous for our clients.
Over the years, I have learnt to overcome these challenges by deploying a number of tools in order to consistently deliver high-quality translations. In my view, in addition to expertise and experience, the two most essential tools are:
In another blog post, I will have to dedicate more time to the extremely interesting subject of machine translation (MT) and computer-assisted translation (CAT). Suffice to say that these tools are now an essential tool for all translators, but for the translation of Regulatory Affairs documents, they are absolutely essential. Firstly, because there is much repetition between the documents and with the use of CAT tools both the workload for the translator and costs for the client are reduced. Secondly, CAT tools help improve the overall consistency of the translations. Once we have updated our translation memories to the latest regulations, directives and guidelines, we can be sure that we are using the most appropriate terminology across all our translations.
Regulatory Affairs documents naturally refer to regulations, directives and guidelines. Most of these governing the use of medicines and medical devices are issued at a European level by the European Medicines Agency (EMA). The second essential tool therefore when translating Regulatory Affairs documents is the EMA website where we have access to a whole collection of documents that will help us ensure accurate translations.
Let’s look for a moment at the following text from a package leaflet:
“Lea todo el prospecto detenidamente antes de empezar a usar este medicamento, porque contiene información importante para usted.
– Conserve este prospecto, ya que puede tener que volver a leerlo.
– Si necesita consejo o más información, consulte a su farmacéutico.
– Si experimenta efectos adversos, consulte a su médico, o farmacéutico, incluso si se trata de efectos adversos que no aparecen en este prospecto. Ver sección 4.”
These documents are standardised across Europe so I cannot translate this freely in any way I might consider appropriate. I must ensure that it complies with the exact wording indicated in the latest template issued by the EMA. These templates provide guidance on how to present the SmPC, Labelling and Package Leaflet and are available in all 24 European languages, available here.
So, following this template as far as possible, I would have to translate the above passage as
“Read all of this leaflet carefully before you start this using this medicine because it contains important information for you.
– Keep this leaflet. You may need to read it again.
– If you have any further questions, ask your doctor or pharmacist.
– If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.”
And out of curiosity, if I wanted to see what this passage might look like in a language I do not understand all I have to do is check the relevant section in the template. So in Hungarian, it would look like this:
“Mielőtt elkezdi alkalmazni ezt a gyógyszert, olvassa el figyelmesen az alábbi betegtájékoztatót, mert az Ön számára fontos információkat tartalmaz.
– Tartsa meg a betegtájékoztatót, mert a benne szereplő információkra a későbbiekben is szüksége lehet.
– További kérdéseivel forduljon kezelőorvosáhozvagy gyógyszerészéhez.
– Ha Önnél bármilyen mellékhatás jelentkezik, tájékoztassa erről kezelőorvosát vagy gyógyszerészét. Ez a betegtájékoztatóban fel nem sorolt bármilyen lehetséges mellékhatásra is vonatkozik. Lásd 4. pont.”
We should also remember if possible to find out which procedure (centralised, mutual recognition or decentralised) has been followed by the MAH to market the medicine as this might slightly affect the wording of the template.
And this brings me on to the question of acronyms and abbreviations. These can truly prove challenging for the translator, especially in more clinical areas where they can be very ambiguous. While Regulatory Affairs documents may contain many, they are usually easily identifiable and generally less ambiguous than in other fields. Fortunately, also, there are several reliable resources, two of which are available on the EMA website.
To find out “Who or what is a MAH?” click here.