25 Aug /10

Language translation and localisation challenges for the pharmaceutical industry in the EU

SmPC, PIL, packaging and labelling medicines, drugs, pharmaceutical

Language barriers should not prevent people from having access to and accurately understanding information about medicines.

The most important and comprehensive document which details the purpose and characteristics of a given drug is the Summary of Product Characteristics (SmPC).
The SmPC is a full, official description of a pharmaceutical product, which lists the name of the active substance, its composition, uses, dosages, pharmaceutical forms and known adverse reactions.

The SmPC is produced for the approval and development of medicines and is the basis of information for healthcare professionals, such as doctors, nurses and pharmacists, and explains how to use and prescribe the medicinal product safely and effectively.

SmPCs are written and updated by the Regulatory Affairs Departments of pharmaceutical companies and are based on their research and product knowledge.

The SmPC is checked and approved by the local or European Union medicine licensing authorities.

The SmPC is then used as the basis for the Patient Information Leaflet (PIL). It is inserted into the drug pack, and includes information about how to use the medicine safely and correctly. The PIL has essentially the same information as the SmPC, but must be written in language that is easily understood by non-professionals.

Drug packaging and internal and external labelling texts are reduced versions of the PIL.

SmPCs and PILs issued by pharmaceutical companies have to meet the requirements of the drug regulatory authorities in the country/countries where the drug will be sold. For European Community countries, on top of the requirements of the country’s own drug regulatory authority this also means meeting the requirements of European Medicines Agency (EMEA).

For medicines EMEA and the various national medicine evaluation agencies require that the Summary of Product Characteristics (SmPC), the Patient Information Leaflet (PIL), and the packaging and labelling texts be presented at least in the official language or languages of the Member States in which the medicinal product is placed on the market.

When more than one language is used, all the texts must be in each individual language and the contents of all language versions must be identical.

A manufacturer cannot apply for a drug registration without submitting the relevant translated and properly localised versions of these documents to the European or national regulatory authorities.

Language translation and localisation challenges for pharmaceutical industry in the EU

23 official EU languages

Pharmaceutical companies manufacturing within the boundaries of the European Union need to make the Summary of Product Characteristics (SmPC), the Patient Information Leaflet (PIL), and the packaging and labelling texts available in up to the 23 official languages of the European Union.

Languages of the European Economic Area, new EU candidate countries and recognised minorities

Additional languages are those countries which are non-EU but EEA members (Norway and Iceland), candidate EU countries (Croatia, Serbia and Macedonia).

Other possible required languages are those of recognised minorities in the EU (such as Catalan, Corsican, Frisian and Welsh).

20 days to produce translations

EMEA sets a strict time frame of 20 days allowed for translated versions of all documents to be submitted.
Within 5 days after the marketing authorisation is given by the CPMP (the EMEA committee responsible for assessing marketing authorisations), initial translations must be provided. By the 20th day, the final revised versions of the translations must be provided to the EMEA in their final publishing format.

Culture specific translation and localisation problems

Differences in norms and conventions of the source and target culture (e.g. legal guidelines for PIL, differences in PIL usability regulations, differences in expressions, symbols and pictograms established by Member States).

Multilingual PIL readability testing

Each language version package leaflet must be written in clear and understandable terms for the patient as well as being comprehensive and legible. PIL readability testing is the procedure by which PILs are tested and reformulated to ensure they meet the aforementioned requirements.

Product updates

Updates to product information can result from changes in legislation or product changes through new discoveries. Such updates generally take place a couple of times per year.
In each case pharmaceutical company must go though processes quite similar to those when applying for the initial drug approval. For this reason, translation is again required.

Consequences of mistranslations

When it comes to medicine specifications, usage, dosage and side effects, incompetent translations and mistranslations can lead to disastrous consequences.

Developing a new medicine is a costly and long process. A faulty translation can result in market delay or lead to product recalls. In some cases, it can even lead to product liability lawsuits.

To eliminate any possible risk, Regulatory Affairs Departments of pharmaceutical companies need to work together with professional language translation providers, preferably on a long-term basis.

Key factors that demonstrate that a pharmaceutical translation provider is an expert in SmPC, PIL, and drug labelling language services

• Ability to structure SmPCs, PILs and drug labels in all EU languages in accordance with the EU directives and guidelines of good practice and requirements of BfArM, EMEA, MedDRA and EDQM standard terms.

• A large team of in-house medical translators who are experts in European regulatory submission and have experience with the latest Quality Review of Documents Groups (QRD) Templates.
QRD templates are a set of documents whose main objective is to set out standard phrasing, terminology, and stylistic preferences for product information as well as to provide guidance on layout. These documents are currently available in 25 languages (23 EU languages, plus Icelandic and Norwegian).

• Assisting pharmaceutical companies in conducting Readability User Tests by participating in the questionnaire creation, translation and localisation for the target group in question, providing relevant language interviewers and interpreters.

• Usage of a coherent content management strategy.
Maintaining area-specific dictionaries and glossaries, enabling the reuse of repetitive content across drug approval-related documents.

• Providing accurate localisation and language adaptation of SmPCs or PILs in accordance with specific project requirements and official legislation requirements, whether in a national or centralised registration or a mutual recognition procedure.

• Delivering precise translations in high volumes and within tight deadlines.