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Poor Translation Has The Chinese Pharmaceutical Industry Updating Nation Wide Requirements:

A Chinese pharmaceutical company, based in the Guangdong Province, was issued a warning letter from the US Food and Drug Administration (FDA) for improperly translating a drug label. The letter stated the Guangdong Zhanjiang Jimin Pharmaceutical Co. violated regulations when it labeled an over-the-counter drug exported to the US, as containing the ingredient hydrocortisone. When the company was asked about the misinforming drug label they said, “There was a translation mistake, and the two APIs (active pharmaceutical ingredients) were believed to be the same ingredient.” The drug in question, Piyanping Anti-Itch Lotion, was recalled in the US, August 30, 2017. The FDA, said the drug manufacturer had failed to provide an action plan to prevent a recurrence. The US regulator suggests Guangdong Zhanjiang Jimin Pharmaceutical Co. find assistance to help them meet requirements of current good manufacturing practice (CGMP) regulations. The critical role of translation in the Chinese pharmaceutical industry is becoming increasingly apparent to more than just the United States. The China Food and Drug Administration (CFDA) has recently issued new directions on translation requirements for registering medical devices in the Chinese pharmaceutical market, which is witnessing an industry wide regulatory update. Landon Lack, CEO of China MedConnect stated, “documentation (and therefore translation) requirements will increase and possibly very significantly if a clinical trial requirement invariably increases the required documentation and associated translation.”

Pharmaceutical Translation Requires a Professional Translator:

Pharmaceuticals are developed, manufactured and used from every point on the globe. The translation of important content and clinical studies aids scientist, drug manufacturers and medical staff all over the world in providing optimal patient care and treatment. Pharmaceutical translation requires absolute precision to ensure patient safety. It’s vital this information be translated correctly in order to avoid a country’s regulatory agency from allowing a dangerous drug to hit the market or worse causing harm or death due to poor translation. When information regarding medication is being translated, there is no room for error. Due to the complexity of content, it’s imperative you partner with a language service company who can give you access to a translator best fit for your specialized translation project. Niki’s Int’l Ltd. is a language service company, dedicated to ensuring your translations are completed with the highest level of accuracy in the field. They partner your translation project with an experienced translator who is proficient in both source and target languages as well as the pharmaceutical subject matter. Working with a translator who is a subject matter expert guarantees difficult industry terminology, mathematical conversions of measurement, portions and ingredients are all clearly understood by readers of the target language.

Translation Through All Stages of The US Drug Development Process:

  • Stage 1, Discovery and Development
  • Stage 2, Preclinical Research
  • Stage 3, Clinical Research
  • Stage 4, Regulatory Review
  • Stage 5, Marketing
  • Stage 6, Sales

In stages one through three case forms, data sheets, questionnaires, consent forms, personal information data and physician findings all need to be translated in order to be read and understood by the specified country’s regulator (stage four). In stage four it’s mandatory all information needed in order to meet the requirements for a country’s regulatory agency is translated pristinely. If there is a translation error, the regulatory agency has the authority to deny the pharmaceutical from being available on the market. In stage five and six of the development process, your language service company can aid you in marketing and sales strategies by localizing your product to appeal to the market you’re targeting. Product information, labeling, packaging, disclosures and marketing materials used to sell the product, need to go through the process of localization… Part Two: The Localization of Pharmaceutical Products

Niki’s Int’l Ltd. is a WBENC-Certified Women’s Business Enterprise with 20 years of language service experience. A global network of highly skilled interpreters and translators are available 24 hours a day, 7 days a week for on-site, telephonic and video remote interpretation services. Our linguists are available in over 350 languages and dialects, and our network includes certified interpreters and translators. Our work is guaranteed with a $1 Million Errors & Omissions policy, so that you can be confident that your project will be completed with the highest level of quality and professionalism within the field. For more information contact us at 1-877-567-8449 or visit our website at www.nilservices.com.

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