A Prescription for Improved Safety

    The pharmaceutical industry has been working in partnership with international regulatory authorities and medical societies since the 1960s to develop standards that promote safety in the creation, testing, manufacturing, and delivery of medicines around the world.

    Language

    An essential part of these safety practices is using clear and precise language to describe a drug’s chemical makeup and directions for usage.

    With a global market, this descriptive language must be translated so the drug can be approved for use in other countries. A professional language services agency can work with you to translate your pharmaceutical communications to meet regulatory standards for domestic and global markets.

    With safety on the line, it’s important to understand what you need to translate, and why. Here are some considerations for translating pharmaceutical communications.

    What to Translate

    The Summary of Product Characteristics (SmPC)explains in detail the purpose and characteristics of any given drug. This description includes:

    • active substances
    • composition
    • uses
    • dosage
    • pharmaceutical forms
    • known adverse reactions

    The SmPCs are used by healthcare professionals for the safe and appropriate prescription and use of the medicine. The SmPC also provides the information used in the Patient Information Leaflet (PIL), which is included with the medication packaging and is written for consumers.

    Don’t limit your translation project to SmCps and PILs. Other pharmaceutical documents that would benefit from translation include:

    • Documentation and content for dossiers
    • Case report forms (CRF)
    • Toxicology reports
    • Manuals
    • Clinical summaries
    • Product updates

    Look for an agency that can handle all your translation needs.

    European Medicines Agency (EMA)Guidelines

    Products sold in Europe must meet the EMA guidelines for SmPC, PIL, and packaging and labeling:

    • Text must be in the official language of the Member States where the product is placed on the market.
    • If more than one language is used, the information must be provided in all languages, and all versions must be identical.
    • The manufacturer must submit the properly translated and localized versions of these documents to the proper authorities before applying for a drug registration.

    With 24 official languages in the EU, translating the SmPC and PIL can be an intimidating task. In addition to the precise language requirements, the EMA has a strict timetable of 20 days for the submission of all translated documents.

    Readability  

    In addition to these standards, all pharmaceutical manufacturers in Europe are required by law to test the readability of PILs. The PILs must be legible, clear, and easy to use. The responsibility falls to the manufacturer to conduct the testing and submit a readability test report.

    A key component to readability is localization. The pharmaceutical documents should be written with the culture in mind, to make sure that the target audience understands the information and is not offended or confused by the language or pictures used.

    Global Marketing

    Translating your marketing materials can help you connect with customers in the target market. Experienced translators can evaluate the marketing content to translate to the target language, identify and adjust cultural references, and adapt the message to appeal to the target audience.

    There are different strategies for cultural adaptation:

    • Globalization translates a message into one language that works for all parts of the world where that language is spoken.
    • Localization translates a message into the target language and gears every aspect of the translated material for the specific geographical location, culture, or community.

    Identifying your target markets can help determine which cultural adaptation approach would work best for your marketing strategy.

    Working with an Agency

    Make sure you work with a professional language services agency (LSA) that understands regulatory constraints and can deliver accurate materials on time and within budget. Also check that the agency you choose has medical translators familiar with EMA regulatory submissions applicable to your project.

    With stringent safety standards in place for communicating pharmaceutical product information, working with professional translators is the best way for your product to be prescribed and used safely around the world.

     

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