Partnerships In Clinical Trials 2012 Media Partner
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Tips for Translation, Localization and Regulatory Compliance in the Pharmaceutical Industry
Pharmaceutical translation and localization is not an option, but an ethical and lawful imperative when new drugs are being tested and existing drugs are being marketed globally. A pharmaceutical company’s successful international presence demands an ethical commitment to the ethnic market. A vast number of the clinical trials are currently held abroad where where accurate translation of highly technical and medical terminology is crucial for many non-English speaking participants.
If you pick up a bottle of one of your prescription medicines you’ll see various types of information on it – dosage and frequency of use, storage instructions, side effects, warnings, etc. – often in more than one language. Based on more than a decade of providing quality translation and localization consulting services to leading companies in the healthcare and life sciences industries, our guest author offers the following tips for translation and regulatory compliance:
1. Do not assume that you can use English-language labels in foreign countries.
In the European Union (EU) countries, for example, several directives, including the Clinical Trials Directive, Medical Device Directive (MDD) and In-vitro Diagnostics Directive (IVDD), have specific provisions that make translation of medical labels mandatory into the language or languages of the country in which the products are being tested, distributed, or sold. See the following directives which govern what labeling and instructions for use must accompany your product: Directive 98/79/EC of 27 October 1998 (IVDD) and Directive 93/42/EEC of 14 June 1993 (MDD).
2. If you do not have the expertise within your company, hire an international regulatory consultant and work with a professional language service provider who has expertise in the specific in-country guidelines.
A consultant who is thoroughly familiar with the labeling and packaging regulations in foreign countries can review all regulatory compliance issues and provide expert guidance to your translators as they begin the translation process. For example, drug manufacturers and medical device companies who plan to test or market their products around the world must meet various in-country regulatory requirements. One of such regulatory requirements is proper translation, design, and content of all labeling and instructions for use. Specifically, the European Union has issued several directives regulating the CE mark, which is required prior to distributing medical and in-vitro diagnostic devices in the EU. Pharmaceutical companies looking to distribute in the U.S. must have certification that the foreign-language labeling is complete and accurate.
3. Do not use a canned machine translation program.
Errors in translating medical labeling or instructions for use could lead to regulatory and/or product/civil liability. Therefore, it is especially important to work with professional translators who have medical and pharmaceutical translation experience, education, or both. Machine translation is not precise enough to accurately translate the highly technical terminology used in medical labels, and worse, could cause a misinterpretation of the actual meaning altogether.
4. Consider developing medical labels for each geographic region with similar regulatory requirements.
More and more pharmaceutical and medical device companies develop region-specific labels or instructions instead of trying to fit all languages into one universal piece. For example, for the countries of NAFTA (United States, Canada, and Mexico), in which FDA-approved drugs can be marketed, the labels would include English, French, and Spanish languages.
5. Build a long term relationship with your professional language service provider.
Developing a new medicine is a costly and long process. A faulty translation can result in market delay or lead to product recalls. In some cases, it can even lead to violation of FDA regulations or product liability lawsuits. To eliminate any possible risk, Regulatory Affairs Departments of pharmaceutical companies need to work together with a professional language translation providers, preferably on a long-term basis. By centralizing the translation process within your organization you will benefit from consistent quality of all translations, faster turnarounds, and reduced translation costs.
Closing Thoughts
There is more to pharmaceutical and medical device packaging and label translation than replacing words with the native language. It is imperative to achieve a translation quality that moves beyond language, cultural, and regional differences, as well as meets all local and international regulatory guidelines.
About the Author
Ting Zhuang is the founder and executive director of
Globalization X-Change Bay Area (GXBA), a non-profit association where Bay Area globalization professionals can “Meet Different” to network and build friendships. She is also the program director and chair of globalization strategy at Proz.com. A native of China, Ting has more than 10 years of in-depth globalization knowledge in leading enterprise product strategies for the international markets in the technology, e-commerce, multimedia, entertainment, pharmaceutical and HR industries. She has taught courses at UC Davis, City University of New York and China Institute. She is also an internationally recognized speaker at many leading industry conferences. Ting holds a MA in Applied Linguistics from UC Davis and speaks four different languages.
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Partnerships in Clinical Trials Asia is your opportunity to establish benchmarks, standards and best practices in the development and commercialization of products in a global marketplace. No other event provides you with a better opportunity! Will you be joining us this October 12-14, 2011 in Shanghai?
