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Voices of Regulatory Translation

https://www.rapporttranslations.com/blog/challenges-technical-translationFree Language Translation Consultations

Nowhere are the matters of voice and audience more crucial than with regulatory translation. CTD dossiers, CMC documentation, biocompatibility reports, SmPCs, PILs, and a host of other regulatory documents require intimate knowledge of the subject matter, strict adherence to terminology, and familiarity with document templates. Imagine handing a regulatory translation project, such as translating a package leaflet for a product like Advil, to your favorite marketing translator. The results could be humorous, but they also could cause a landslide of headaches. Let’s explore five major differences between regulatory and marketing translation.

1. Types of Words Used – Marketing language is persuasive; regulatory language is factual and non-biased. Typical adjectives used by marketing departments include: wonderful, safe, delicious, easy, and great. All are words that regulatory documents avoid. The same is true for verbs. Words like choose, know, like, need, and buy are generally avoided on regulatory documents. Once again, it’s persuasive versus objective language.

Take a typical advertisement for Advil Cold & Sinus, which proclaims, “The power of decongestants and antihistamines gives you relief you can trust.” Can you pick out the undertones of persuasion? There’s the hint that the product is “powerful” and “trustworthy.”   And the sales pitch is for “relief.”

On the other hand, regulatory language is neither short nor suggestive. Because safety is at the core of all regulatory documents, scientific explanations rather than marketing slogans are required. Take, for instance, the patient information leaflet (PIL) inside a package of Advil Cold & Flu, typically several pages long. Just some of the information covered includes: (1) Ingredients in the medicine – “This medicine contains ibuprofen, a Non-Steroidal Anti-Inflammatory drug (NSAID) which works by relieving pain and reducing high temperature and fever. …” (2) Reasons not to take the drug – “Do not take Advil Cold & Flu if you are allergic or have severe kidney disease (kidney failure), severe liver disease, heart disease, severe heart failure, or high blood pressure …” (3) Possible side effects – “Allergy: Unexplained wheeziness, shortness of breath, skin rash, itching, bruising, or facial swelling. …”

You probably noticed that the descriptions in the PIL aren’t exactly geared towards getting customers excited about buying the medication. Good translation companies understand the purpose of regulatory documents like PIls. Working with clients like ClinSmart, a CRO that offers solutions to expedite the reporting and tracking of adverse events, and Ranfrac, a leading manufacturer of precision medical instruments, Rapport International understands the demands of regulatory translation and can appoint the best translators to get the job done.

2. Changing Focus – The focus of regulatory documents pertains to the approval and compliance of medical devices, pharmaceuticals, and in vitro diagnostics products, while the focus of marketing materials is consumer spending. Both focuses are important, but one precedes the other. Similar to construction projects, the regulatory translation process is like laying a foundation – footers need to be poured, blocks need to be placed and cement has to dry – before upward construction begins. The same is true with bringing products to market. Regulatory procedures lay the groundwork for marketing campaigns to unfold.

While the FDA oversees the regulation and safety of new medicines and medical products in the United States, other organizations exist, such as the European Medicines Agency (EMA), China’s SFDA, South Korea’s KFDA, and Japan’s PMDA, that regulate these same products in international markets. Error-free translations are key to moving any product through the manufacture-to-market pipeline; therefore, picking a quality translation agency to ensure that regulatory formats, validated certifications, expert reviewers, and fast turnaround service is fundamental.

Once again, let’s look at the PIL, also known as the Package Leaflet for veterinary medicines, that is always a component of regulatory approval for any medicine or medical device. Information contained in any PIL, regardless of what language it is translated into, must be linguistically and technically accurate; culturally suitable for the audience it’s intended for (patient or guardian), and fully compliant with all of the regulatory requirements for such documents. The focus of such leaflets is to provide additional information about the drug, not to highlight its selling points.

For instance, look at a Package Leaflet for REVOLUTION®, a veterinarian product manufactured by Pfizer. One of the first items listed is “Caution: US Federal law restricts this drug to use by or on the order of a licensed veterinarian.” It’s a mandatory part of the leaflet, but hardly what a marketing translator would want to emphasize. The Description, too, includes specific details that might baffle someone in marketing:

Revolution (selamectin) Topical Parasiticide is available as a colorless to yellow, ready to use solution in single dose tubes for topical (dermal) treatment of dogs six weeks of age and older and cats eight weeks of age and older.”

The description goes on to mention the exact dosage per weight (2.7 mg/lb or 6mg/kg) of selamectin and the chemical composition of the medication. Although someone with a background in marketing will eventually take this “dry” information and add a bit of creativity to create a slogan like, “Try this easy-to-use medication to cure your dog or cat’s flea problem,” a regulatory translator would never alter words or try to change the fact-by-fact voice that is required for package leaflets.

3. Different Audiences – Audience is important for both regulatory and marketing translators, but for regulatory matters, identifying audience is important because readability is the goal. Knowing the purpose of each regulatory document helps to define the audience and establish the voice of the translation. PILs are for the patient or guardian to read but something like the Summary of Product Characteristics (SmPC) is a specific document required within the European Commission, as well as by the FDA for the USA, before any medicinal product is authorized for marketing. It is not intended for consumers but rather, for health professionals, so that they can understand how to use a product safely and effectively. SmPCs typically cover information like: name of the medicinal product, qualitative and quantitative composition, pharmaceutical form, clinical particulars, as well as other technical aspects of the product.

Hiring translators with suitable backgrounds and experience is crucial for demanding regulatory translations like SmPCs. The legal and scientific aspects of regulatory translation can make typical regulatory sentences written in English sound like a foreign language. Could a marketing expert decipher the following sentence?

This subpart identifies those products in which the Administrator has found an unsafe condition as described in Sec. 42.3 and …”

Truthfully, a regulatory translator wouldn’t fare any better working with material written for an audience familiar with marketing:

The user will be reached using media that demonstrates a high composition of the target and we hope to engage prospective consumers with high share-of-voice.”

Knowing the appropriate audience and determining the readability of texts ultimately determines whom the translator will be. When Rapport International works with Beth Israel Deaconess Medical Center or the Rhode Island Blood Center, they understand that the intended audience is the patients visiting those facilities. On the other hand, translation projects for Dynisco Instruments, a world leader in developing innovative sensors, controls, and instruments, are geared towards regulatory agencies.   Each project is assigned an appropriate translator by Rapport International, but companies always have the final say about accepting or rejecting the suggested translator.

4. Perspectives On Process – Typically, regulatory translation is a multi-step process that certified translation agencies oversee by assigning a project manager to the team. Common steps in the process of translation may include:

* Extracting the text from the source

* Converting the source language text into the target language

* Verifying that templates used are up-to-date

* Reading & revision by a third party to assure that terminology is correct

* Editing for proper style & consistent voice

* Putting the document back into its original format (e.g., Word document, web page, etc.)

* Proofreading to ensure that formatted translations display properly

* In-country review by a native-speaking expert

Marketing, too, follows a process, but it differs dramatically. Translators working with advertising material, follow a process that often includes:

* Analyzing the business name and its positioning statement (think Campbell Soup’s “M’mm, M’mm Good!” or Nike’s “Just do it!”) so that slogans, once translated, are clear, consistent, and credible in the target language

* Assessing if brand and company names are functional in the target language (e.g., does the name have the right sound in translated language? Does it look appropriate when written in a foreign language that uses characters? Can it be trademarked in the target country?)

* Deciphering if the company’s platform is adaptable to the target language

Although both regulatory and marketing translators follow specific processes, the focus of each is different.

5. Respecting Taboos – With regulatory translation, the taboos concern format and choice of words. As mentioned before, creativity is not encouraged; rather, a strict adherence to format, terminology, and protocol are expected. It’s like following a mathematical formula that if altered, will cause regulatory agencies to raise red flags. Something as simple as a consent form for a trial study must include basic information such as: description of the study, purpose of the study, and who can participate. It cannot be an enthusiastic call for participants promising wonderful results. Details about inconveniences, discomforts, and risks must be adequately explained.

Taboos in the marketing world have more to do with “localizing” advertising material so that it’s not offensive or confusing in the target language. Slogans, in particular, need the scrutiny of expert marketing translators. Take, for instance, these famous slogans and how they got lost in translation:

* “Pepsi brings you back to life” in Mandarin translates to, “Pepsi brings your ancestors back from the grave.”

* Coors Brewing Company’s slogan, “Turn it loose,” became “Suffer from diarrhea,” in Spanish.

Even small errors can doom a new product’s salability. Everything from colors used in print ads to specific word choices needs to be analyzed for appropriateness.

Regulatory and marketing translations are equally important, but knowing the demands of each is paramount for successfully launching products into new markets. Never place the success of your business in the hands of a translation agency that doesn’t match the needs of your project to the expertise of the right translator. And always ask questions about previous experience, customer satisfaction, quality assurance processes, and turnaround time before committing to a contract. Click here for a free quote.

Categories: Problems & Solutions, Quality, Multilingual Growth

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