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 individual 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 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 aligning with the latest applicable template.
Language Translation and Localisation 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 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 for the submission of the translated versions of all documents. Initial translations must be provided within 5 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 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) 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 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 every year. In each case, 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 and 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 also has experience with the latest Quality Review of Documents (QRD) groups, templates
- 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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