For medicines, EMA and various other national medicine evaluation agencies require that certain documents, including the Summary of Product Characteristics (SmPC), the Patient Information Leaflet (PIL), and the packaging and labeling texts be presented in the official language or languages of the Member States or markets in which the medicinal product is to be placed. When more than one language is employed, there should be a text available in each language, and their contents should all be identical. A manufacturer cannot apply for a drug registration without submitting these relevant documents, all appropriately translated and localized, to the European or national Regulatory authorities. Even after obtaining the authorization, the company must keep the concerned authority informed about all the post-authorization labeling changes done in line with the product updates through relevant communication channels.
The organization must also be on the lookout for periodic recommendations given by Pharmacovigilance Risk Assessment Committee (PRAC) which may impose a change in product labeling. Additionally, tracking EMA’s reviews and updates on Quality Review of Documents (QRD) templates for product information will help in local label comparison and thus, align with the latest applicable template.
Language Translation and Localization Challenges for Pharmaceutical Industry in the EU
Pharmaceutical companies manufacturing within the borders of the European Union need to make the Summary of Product Characteristics (SmPC), the Patient Information Leaflet (PIL), and the packaging and labeling texts available in up to twenty-three (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).
Twenty (20) Days to Produce Translations
The EMEA sets a strict timeframe of twenty (20) days for the submission of the translated versions of all documents. Initial translations must be provided within five (05) days. After the marketing authorisation is given by the CPMP, the EMEA committee is responsible for assessing marketing authorisations. By the 20th day, the final revised versions of the translations must also be provided to the EMEA in their final publishing format.
Culture-Specific Translation and Localization 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 the Member States) must also be considered while translating documents.
Multilingual PIL Readability Testing: Each language package leaflet must be written in a clear, comprehensive, and legible manner. The patient should be able to understand what is written on it. Patient Information Leaflet (PIL) readability testing is the procedure by which PILs are tested and reformulated to ensure that they meet the requirements.
Product Updates: Updates to product information can result from changes in legislation or product changes through discoveries. Such updates generally take place a couple of times every year. In each case, the pharmaceutical company must go through processes quite similar to those they undergo when applying for the initial drug approval. For this reason, the translation of documents 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 lengthy process. A faulty translation can result in a market delay or lead to product recalls. In some cases, it can even lead to product liability lawsuits. In such a scenario, and to eliminate risk factors, RA experts need to collaboratively work with professional language translation providers, preferably on a long-term basis.
To assist organizations, sail through the European pharma market, Freyr offers specialized labeling services for the region.
- Quality Review of Documents (QRD)
- Drafting/creating Summary of Product Characteristics (SmPC), Patient Information Leaflet (PIL), and Labeling text (LT)
- Creation and review of Annex 1,2,3 & 4
- Linguistic review coordination
- Visual Quality Control (QC) of translated labels
- Biosimilar product labeling
- Labeling changes based on PRAC recommendations
- Local label comparison with QRD template
- Biosimilar innovator label tracking
- The ability to structure EU SmPCs, PILs, and drug labels in accordance with Europe directives.
- Possesses a large team with specific expertise in the European Regulatory submission that has experience with the latest Quality Review of Documents (QRD) groups, templates, etc.
- Assists pharmaceutical companies in conducting Readability User Tests by participating in questionnaire creation, translation, and localisation for the target group in question, while also providing relevant language interviewers and interpreters.
- Usage of a coherent content management strategy. This includes maintaining area-specific dictionaries and glossaries and enabling the reuse of repetitive content across drug approval-related documents.
- Provides accurate localisation and language adaptation of EU 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 labels in high volumes and within tight deadlines.
To streamline end-to-end Regulatory labeling practice from creation to tracking to managing in company of any size, Freyr offers a centralized labeling life cycle management software, Freyr LABEL. Right from creating, tracking and managing company core data sheet (CCDS) deviations, CCDS updates, and developments to creating, implementing, and inspecting multi-lingual regional labels as well as custom reporting. Freyr LABEL puts companies in total control of all their Regulatory labeling compliance needs.
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