| Language barriers should not prevent people from | | | | translations must be provided. By the 20th day, the |
| having access to and accurately understanding | | | | final revised versions of the translations must be |
| information about medicines. | | | | provided to the EMEA in their final publishing format. |
| The most important and comprehensive document | | | | • Culture specific translation and localisation |
| which details the purpose and characteristics of a | | | | problems |
| given drug is the Summary of Product Characteristics | | | | Differences in norms and conventions of the source |
| (SmPC). The SmPC is a full, official description of a | | | | and target culture (e.g. legal guidelines for PIL, |
| pharmaceutical product, which lists the name of the | | | | differences in PIL usability regulations, differences in |
| active substance, its composition, uses, dosages, | | | | expressions, symbols and pictograms established by |
| pharmaceutical forms and known adverse reactions. | | | | Member States). |
| The SmPC is produced for the approval and | | | | • Multilingual PIL readability testing |
| development of medicines and is the basis of | | | | Each language version package leaflet must be |
| information for healthcare professionals, such as | | | | written in clear and understandable terms for the |
| doctors, nurses and pharmacists, and explains how to | | | | patient as well as being comprehensive and legible. |
| use and prescribe the medicinal product safely and | | | | PIL readability testing is the procedure by which PILs |
| effectively. | | | | are tested and reformulated to ensure they meet |
| SmPCs are written and updated by the Regulatory | | | | the aforementioned requirements. |
| Affairs Departments of pharmaceutical companies | | | | • Product updates |
| and are based on their research and product | | | | Updates to product information can result from |
| knowledge. | | | | changes in legislation or product changes through new |
| The SmPC is checked and approved by the local or | | | | discoveries. Such updates generally take place a |
| European Union medicine licensing authorities. | | | | couple of times per year. |
| | | | | In each case pharmaceutical company must go |
| The SmPC is then used as the basis for the Patient | | | | though processes quite similar to those when applying |
| Information Leaflet (PIL). It is inserted into the drug | | | | for the initial drug approval. For this reason, translation |
| pack, and includes information about how to use the | | | | is again required. |
| medicine safely and correctly. The PIL has essentially | | | | • Consequences of mistranslations |
| the same information as the SmPC, but must be | | | | When it comes to medicine specifications, usage, |
| written in language that is easily understood by | | | | dosage and side effects, incompetent translations |
| non-professionals. | | | | and mistranslations can lead to disastrous |
| Drug packaging and internal and external labelling | | | | consequences. |
| texts are reduced versions of the PIL. | | | | Developing a new medicine is a costly and long |
| SmPCs and PILs issued by pharmaceutical companies | | | | process. A faulty translation can result in market |
| have to meet the requirements of the drug | | | | delay or lead to product recalls. In some cases, it can |
| regulatory authorities in the country/countries where | | | | even lead to product liability lawsuits. |
| the drug will be sold. For European Community | | | | To eliminate any possible risk, Regulatory Affairs |
| countries, on top of the requirements of the | | | | Departments of pharmaceutical companies need to |
| country's own drug regulatory authority this also | | | | work together with professional language translation |
| means meeting the requirements of European | | | | providers, preferably on a long-term basis. |
| Medicines Agency (EMEA). | | | | |
| For medicines EMEA and the various national medicine | | | | Key factors that demonstrate that a pharmaceutical |
| evaluation agencies require that the Summary of | | | | translation provider is an expert in SmPC, PIL, and |
| Product Characteristics (SmPC), the Patient | | | | drug labelling language services |
| Information Leaflet (PIL), and the packaging and | | | | • Ability to structure SmPCs, PILs and drug labels |
| labelling texts be presented at least in the official | | | | in all EU languages in accordance with the EU |
| language or languages of the Member States in which | | | | directives and guidelines of good practice and |
| the medicinal product is placed on the market. | | | | requirements of BfArM, EMEA, MedDRA and EDQM |
| When more than one language is used, all the texts | | | | standard terms. |
| must be in each individual language and the contents | | | | • A large team of in-house medical translators |
| of all language versions must be identical. | | | | who are experts in European regulatory submission |
| A manufacturer cannot apply for a drug registration | | | | and have experience with the latest Quality Review |
| without submitting the relevant translated and | | | | of Documents Groups (QRD) Templates. |
| properly localised versions of these documents to the | | | | QRD templates are a set of documents whose main |
| European or national regulatory authorities. | | | | objective is to set out standard phrasing, |
| | | | | terminology, and stylistic preferences for product |
| Language translation and localisation challenges for | | | | information as well as to provide guidance on layout. |
| pharmaceutical industry in the EU | | | | These documents are currently available in 25 |
| • 23 official EU languages | | | | languages (23 EU languages, plus Icelandic and |
| Pharmaceutical companies manufacturing within the | | | | Norwegian). |
| boundaries of the European Union need to make the | | | | • Assisting pharmaceutical companies in conducting |
| Summary of Product Characteristics (SmPC), the | | | | Readability User Tests by participating in the |
| Patient Information Leaflet (PIL), and the packaging | | | | questionnaire creation, translation and localisation for |
| and labelling texts available in up to the 23 official | | | | the target group in question, providing relevant |
| languages of the European Union. | | | | language interviewers and interpreters. |
| • Languages of the European Economic Area, new | | | | • Usage of a coherent content management |
| EU candidate countries and recognised minorities | | | | strategy. |
| Additional languages are those countries which are | | | | Maintaining area-specific dictionaries and glossaries, |
| non-EU but EEA members (Norway and Iceland), | | | | enabling the reuse of repetitive content across drug |
| candidate EU countries (Croatia, Serbia and | | | | approval-related documents. |
| Macedonia). | | | | • Providing accurate localisation and language |
| Other possible required languages are those of | | | | adaptation of SmPCs or PILs in accordance with |
| recognised minorities in the EU (such as Catalan, | | | | specific project requirements and official legislation |
| Corsican, Frisian and Welsh). | | | | requirements, whether in a national or centralised |
| • 20 days to produce translations | | | | registration or a mutual recognition procedure. |
| EMEA sets a strict time frame of 20 days allowed | | | | • Delivering precise translations in high volumes |
| for translated versions of all documents to be | | | | and within tight deadlines. |
| submitted. | | | | If you require pharmaceutical translation services |
| Within 5 days after the marketing authorisation is | | | | please feel free to contact EVS Translations UK Sales |
| given by the CPMP (the EMEAcommittee responsible | | | | Manager – Mr Gregg Babbs, for a detailed |
| for assessing marketing authorisations), initial | | | | quotation by phone 0044-1159-644283. |