Tips for Translation and Regulatory Compliance in the Pharmaceutical and Medical Device Industries Medical Translation Translation agencies
Home More Articles

Become a Member!

Translation Jobs Translation Agencies

Tips for Translation and Regulatory Compliance in the Pharmaceutical and Medical Device Industries

 

By Global Language Solutions,
a full-service translation company,
Newport Beach, California, U.S.A.

www.globallanguages.com











Become a member of TranslationDirectory.com at just $8 per month (paid per year)


Advertisements:







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. The distribution of drugs and devices across borders has done away with translating packaging and labels as a luxury or value-add and, instead, made it a highly regulated, and more often than not, required process. Based on more than a decade of providing translation services to leading companies in the healthcare and life sciences industries, GLS 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 translation firm 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. Assign a point person within your organization for the management of all translation projects. As translation mistakes can delay product approvals and launches, managing translations becomes a critical component of the medical device and pharmaceutical global distribution process. By centralizing the translation process within your organization you will benefit from consistent quality of all translations, faster turnarounds, and reduced translation costs.

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. For more information about translation tips and tools in the pharmaceutical, medical device, clinical research, and healthcare industries, visit http://www.globallanguages.com.

About Global Language Solutions

Global Language Solutions (GLS) is a full-service translation company delivering solutions in over 100 languages to increase its clients’ multicultural and international market share. The company’s expertise includes translation of product labeling, instructions for use (IFUs), ,manuals, informed consent forms, protocols, advertisements, IVRS scripts, and more. For additional information, visit http://www.globallanguages.com or call +1-949-798-1400.

 













Submit your article!

Read more articles - free!

Read sense of life articles!

E-mail this article to your colleague!

Need more translation jobs? Click here!

Translation agencies are welcome to register here - Free!

Freelance translators are welcome to register here - Free!








 

 

Free Newsletter

Subscribe to our free newsletter to receive news and updates from us:

 

Menu

Become a Member!
Recommend This Article
Read More Articles
Search Article Index
Read How to Work at Home
Obtain Translation Jobs
Visit Language Job Board
Post Your Translation Job!
Register Translation Agency
Submit Your Resume
Find Freelance Translators
Submit Your Article
Subscribe to Free Newsletter
Buy Database of Translators
Buy Database of Agencies
Obtain Blacklisted Agencies
Advertise Here
Use Free Translators
Use Free Dictionaries
Use Free Glossaries
Use Free Software
Post Your Free Ad
Vote in Polls for Translators
Read News for Translators
Read our FAQ
Read Testimonials
Read More Testimonials
Read Even More Testimonials
Read Yet More Testimonials
Become Our Customer
Use Resources
Use Site Map
Admire God's Creations

christianity portal
translation jobs

 

 
Copyright © 2003-2017 by TranslationDirectory.com
Legal Disclaimer
Site Map