Among the various linguistic sectors managed by the TIN team, pharmaceutical translations is certainly one of the most delicate. The linguists who specialize at our office in the medical field uses the utmost accuracy and fidelity to the original text, know the technical and scientific terminology and keeps constantly up to date with respect to the regulations governing the international pharmaceutical system.
The demand for pharmaceutical translations has increased significantly in recent years. The free movement of medicines in the European Union has led to a thriving import market from abroad. It is the phenomenon of the so-called parallel import of drugs from abroad with which some corporations introduce drugs into Italy produced and marketed in other countries of the European Union. The drug distributed in Italy will be a "parallel" drug, which has the same name and composition as the original. The task of the medical scientific translator is to precisely translate the different parts of the drug, from the packaging to the package leaflet.
In regard to pharmaceutical translations, the first thing you think of immediately is the translation of the package leaflet. But there are also other moments in the production of a drug in which the figure of a medical-scientific translator is indispensable. In fact, the distribution of medicines is increasingly being played out on a European scale.
It is a document reserved mainly for "insiders", in other words doctors, pharmacists and professional nurses. The summary of product characteristics can be considered the identity card of the drug, because all the information related to its validity, efficacy and safety is mentioned there. The CPR is a text that greatly commits our medical-scientific translators, first of all because the language used is technical and full of acronyms to be localized. This document-based example is also periodically updated based on changes made to the drug.
Translating with a clear and easily understandable style. This is the challenge facing each of our linguists when the translation of a package leaflet is requested. The leaflet is located inside the package of the drug and contains all the information necessary for its correct use. In summary the composition, dosage, use and storage methods, interactions with other medicines or substances and any side/undesirable effects. The recipients of the text are the patients, so potentially anyone. This is why clarity and accessibility are essential when translating package leaflets.
Before a pharmacological product becomes definitive, the advice of our translation agency is required at different stages of the chain: from the clinical research that precedes production that is conducted in several countries where it is determined whether an experimental drug must be approved and made available to the public as a therapy, to the drafting of regulatory documents and certificates of truthfulness. And, not least, in the phase of marketing of the drug as in the next one, authorization from the AIFA, drug regulators like the EMEA or the FDA.
It is therefore clear that specializing in pharmaceutical translations does not only mean dealing with packaging and package leaflets. In fact, the linguist could be faced with texts of clinical research laboratories or dossiers issued by regulatory offices or even documents intended or issued by government bodies. The advice of a linguist, for example, may be necessary in the preparation of dossiers that pharmaceutical corporations submit to the competent authorities to obtain marketing authorization (MA). Of vital importance in the pharmaceutical sector are also the translations of articles for specialized journals and scientific publications in general.
Before being distributed in Italy, a medicine must obtain the authorization of the AIFA (the Italian Medicines Agency). The document with which the agency establishes the entry onto the market of the drug is called the AIC (Marketing Authorization). The decision is usually entrusted to a team of experts who evaluate the quality, safety and efficacy of the medicine and draft the document. The drug is also assigned an identification code (MA number): from that moment the medicine is authorized to be marketed also in the European Economic Area (EEA). The recipients of this text are part of the scientific community, so the document is full of technicalities: Translation-IN translates the AIC because it has mastered the pharmacological jargon and pays attention to every detail.
The complexity and delicacy of the subject mean that pharmaceutical translations must be entrusted ONLY to linguists specialized in the field. But at Translation-IN it is NEVER a solitary job, as happens in most translation areas. In carrying out a pharmaceutical translation, the linguist cannot disregard working with experts in the field, who will have the function of supporting and reviewing the work performed by the translator. Few areas, such as pharmaceutical translation, require collective work, in which the synergy between linguists and experts in the medical sector ensures ONLY optimal results.
