Tips for Translation and Regulatory Compliance in the Pharmaceutical and Medical Device Industries
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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:
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).
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
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.
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.
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.
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.
Global Language Solutions
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,
or call +1-949-798-1400.
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