If, in general, accuracy in the translation of any text is in itself an essential requirement, in the field of pharmaceutical translations – where public health is at stake – this statement is doubly true.
And if, in the past, pharmaceutical companies entrusted in-house staff with the translation service – people with high scientific competence but without the necessary linguistic qualifications – today the importance qualified and specialised experts translating materials on drugs and therapies has been finally understood.
The documentation concerned by this type of translation includes, first of all, the materials circulating information from the pharmaceutical company to health professionals and patients. The translation of the Summary of Product Characteristics (addressed to doctors) and of the Patient Information Leaflet (used by patients) requires not only a competence in the foreign as well as the mother language, but also awareness about the existence of national and European standards, that cannot be overlooked.
For example, it is necessary to be aware of the QRD templates (Quality Review Documents), made available by the European Medicine Agency in all the official languages of the European Union for all the procedures provided for by the regulations, as well as of the standard terms for the classification of adverse events available in dedicated databases, accessible on subscription. National norms on the readability of PILs are also a key factor the translator should be familiar with, as well as the policy of the different national Agencies on the translation of the Product Information for generic drugs and biosimilars.
Pharmaceutical translations, however, do not regard only this kind of materials: the documentation to be prepared for the marketing authorisation of a product may also need to be translated.
During the investigational phase, for instance, clinical trial reports and protocols, informed consents from the subjects involved, they may all require a translation, as well as the product dossier to be submitted to the national competent authority to obtain a marketing authorisation. Once on the market, also the scientific information materials, papers from literature, monographs and brochures for the advertising of medicines to health professionals can also come directly from a foreign company, thus requiring a translation.
Not to mention the fact that foreign companies – in order to manage their products in Italy – often need the translation of deficiency letters, official information by the Italian Medicine Agency, manuals and guidelines to use the services offered by the Agency itself. This means that, in the frame of the European regulatory system, linguistic mediation is almost essential, although the submission of documents in other languages is a frequent option (but sometimes, also in this case, a sworn translation is required).
To achieve the desired purposes, such mediation shall necessary come from specialised translators, supported by modern tool, such as CAT tools and translation memories, ensuring accuracy and consistency in the management of translation projects. On the other hand, the subsequent revision and quality control can be carried out by a team of experts checking the correspondence with the original texts and the correct use of terminology.
A team work where different professionalisms put their expertise and knowhow at the service of public health.
Written by: Maria Pia Felici