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

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:

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 accurate.

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.

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.


Top 10 Tips for Website Translation

Take your website across cultures with these actionable tips preparing a website — including programming, copy, flash and video — for a new language market is no small feat. But with the right planning, approach and execution, your website will reach across borders and motivate your target audience to interact with your brand. Here are our top-10 tips for avoiding common online localization pitfalls:

Align your site and global business strategy.

Is your site supporting local offices in each market, or is your international presence online only? Look at your business infrastructure to ensure it can support the multilingual site objectives — and vice-versa. Items to consider include local legal requirements, local marketing, local customer support (email, call centre), payment processing, sales fulfilment systems and more.

Strategize your multilingual navigation.

An important but often overlooked aspect of successful web localization include helping people find your site, such as geo-targeting, Search Engine Optimization (SEO), user settings and clear user navigation methods (e.g. pull down menu or splash screen with languages).

Use a Content Management System (CMS).

Maintaining site content becomes more complex as you add languages. If you have a large and frequently changing site, use a global-ready CMS to manage the content. Important features include:

  • a. Ability to easily export and re-import content in a localization-friendly format such as XML
  • b. Filtering and workflows for new/updated content
  • c. Support for all targeted languages

Stick to standards and Unicode.

Adhering to generally accepted coding standards (for scripting and middleware, as well as HTML) is part of best practices in general, but also benefits localization in particular. Use Unicode for any applications handling content and encode files containing localizable text (e.g. HTML and XML) as UTF-8. Make sure to include your char set declaration in the file.

Get ready for text expansion and contraction.

Keep in mind that localized text will generally be longer than English, although many Asian languages require less space than English. Check your design and code to ensure that different text lengths are supported. A common issue-prone area is the horizontal navigation bar, which needs to be able to accommodate varied text lengths.

Get your graphics and Flash ready.

Graphics and Flash can play an important part in your website. Be aware, however, that complex graphics and Flash elements in particular can slow down the localization process if not set up for localization at the outset. Examples include externalizing text that will need translation in Flash or graphics and anticipating culturally appropriate imagery in advance.

Consider global, regional and local site content.

Determine what content is global and can be translated for all countries (e.g. corporate messaging and product descriptions) and what content is specific to particular regions or markets (e.g. local press and legal). Design the site and workflows to accommodate these content types.

Plan for updates and maintenance.

How frequently do you plan to update your site? Maintaining daily updates across languages will require a highly automated process between your CMS and your provider. If the updates are less frequent (monthly or quarterly) you may not need to invest as much in automation.

Build a matching source site.

If you are planning to localize only part of your website, it is best to build out that new partial website first before you hand off files for localization. This will enable a review and sign-off on the localization content by your local offices, as well as ensure that the partial website is functioning correctly. It also creates a matching source site to test the localized sites against during linguistic QA.

Consider multilingual search.

Don’t expect that just translating the site will bring a rush of international customers. You need to optimize for search. This includes all the same elements of your domestic search campaigns including creating local domains, using relevant keywords for the URLs, metadata and content, link building etc.

Business Translation Services – Tips for Working with an Interpreter

Interpreters are becoming more and more popular and in great demand. With people from all over the world taking part in business events such as conferences, business meetings and marketing campaigns, the language barrier can be a tough hurdle to get over. The interpreter is an important piece to the puzzle when it comes to this type of communication, and knowing how to hire one is a must for international businesses.

You can certainly just go out and hire one, but that would be too easy. You want to research the business translation service you are interested in, because a business translation service that provides interpreters will only work with qualified and experienced interpreters. They will also ensure that an interpreter is familiar with the subject matter.

Working with an interpreter can also bring unforeseen challenges, because the aspect of their job can be cumbersome and stressful. They perform “on the spot” work, and there is no time to think or consider what is being said. They don’t have breaks like other employees either. So, in order to ensure you get the best out of an interpreter, good communication is necessary.

Here are some valuable tips when working with a business translation service interpreter.

Make sure you communicate exactly what needs to be accomplished to the interpreter prior to the start of the job.

Provide the interpreter with a briefing of what will happen in the meeting, and try to provide him or her with background information on the subject matter. Let them know the topics and issues that will be covered.

If you have any materials that have been pre-printed, make sure the interpreter has a copy and time to review the materials. This will help when the interpreter is in front of the live audience, as it will not be the first time reading it.

Humor is a bad thing. You want to avoid it like the plague. What you find funny, the other culture may find offensive. So, be as professional as possible. An interpreter from a respectable business translation service will know to avoid humor.

If you have set aside an hour for the meeting, you will need to double this time, due to the use of the interpreter. Meetings generally take twice the amount of time. If it’s a presentation, it may even take longer, so plan your time accordingly.

In order to help the interpreter, try to speak slowly, so they can reiterate exactly what you are saying. It can be a stressful job for them and if you speak too quickly, this can make the job harder for them. Remember, you don’t want the quality of the translation to be hindered in any way.

An interpreter from a business translation service will already know this, but avoid any emotion when speaking. Sometimes emotions can be taken the wrong way, and you certainly don’t want the interpreter to communicate your emotions along with your words. Make sure the interpreter doesn’t answer questions on your behalf. Even if the answer is simple, the interpreter should still convey this to you. If an interpreter starts to speak on your behalf, this can have numerous negative consequences

These are just a few tips to get you started. You will more than likely have a reputable business translation service that will provide an interpreter that is versed in all of the information above. But, if not, you want to make sure they are clear on all points, as not to make you look bad.