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Problems and Best Practices

Simply translating a document is not enough; one needs to ensure that the intended message is still conveyed accurately. Reviewing translations is often a cumbersome process; however, the use of web-based systems can prove to be more efficient while also reducing errors.

Most pharmaceutical companies and medical device manufacturers serve international markets,which means they need to translate their product information (for medicines) and instructions for use (for medical devices).Many companies have defined a good system for quality assessment of translations, while others still seem to be in the stone age.

Why do we do In-Country Reviews?

For medicines and for medical devices the legal framework for translation review is not entirely the same. Let’s first look at the legal background to translating information around medicines. European Directive 2004/27/EC relating to medicinal products for human use states that the “package leaflet must be clearly legible in the official language or languages of the member state in which the medicinal product is placed on the market”. The guideline on the readability of the labelling and package leaflet of medicinal products for human use states that “the quality of translation should be the focus of a thorough review” by the registration holder (cited in the Readability Guideline 2009). The registration holder is responsible for the production of “faithful” translations, in consultation with the national health authorities or the European Medicines Agency. The translations will also have to be “legible, clear and easy to use”, which has to be assessed during “user consultation” (readability testing). For registration documents, the review takes place during the translation phase by the pharmaceutical company with the translation vendors; after submission of all translations, which should take place between day 210 and day 215 of the EMA registration procedure, a linguistic review is carried out by the health authorities in each EU member state.

For medical devices the legal background for translation is different, but the bottomline is that all user and patient information must be translated into the official language(s) of the country in which the manufacturers want to sell the product. This requirement is defined in European Directive 93/42/EEC, often referred to as the Medical Devices Directive (MDD), which covers all equipment intended to be used for the “diagnosis, prevention, monitoring, treatment or alleviation of disease, (...) injury or handicap, investigation, replacement or modification of the anatomy or of a physiological process, control of conception.” It also covers a broad product range, from a first aid kit to MRI scanner. Two separate directives concern active implantable devices, such as pacemakers or infusion pumps, and in vitro diagnostics devices, such as blood tests. In separate guidance documents it is defined that “as part of the quality system (...) the manufacturer should have procedures for ensuring accurate translation of, for example, labelling, instructions for use and product claims in marketing material. These are especially important for user instructions where the safety and claimed performance of the device may be compromised through inadequate translation.”

How are In-Country Reviews Done?

Pharmaceutical companies and medical device manufacturers need to translate their product information, and they need to have a procedure in place to check that it is carried out properly. How do they make sure that the translations are executed well? There does not seem to be a ‘one-way-fits-all’ method; rather, there are several ways to assess translation quality.

In most cases, translations are performed by an external vendor. Translations, along with the original version of the document – most often written in English – are sent to the national offices in the countries concerned. They compare the source and target language versions, make changes if necessary, and return the revised translation to HQ for the next steps in the regulatory process. For medicines, the translated registration documents are checked by the national health authorities at a point during the registration procedure. For medical devices, the notified body – usually a test organisation, such as TÜV, KEMA, or TNO in Europe, or United Labs (UL) in the US – is responsible. These organisations are responsible for checking whether a device conforms to the various directives and standards; as user documentation is legally a part of the device, this would need to be checked as well. The reality is that many notified bodies do not actually check the translations, and only check whether the safety sections in the original version of the documentation are acceptable.

What are the Problems?

Many problems are caused by the reviewer who wants to rewrite the original, or who does not seem to know what he is doing, or who has unusual ways of entering review comments. In several cases review problems are actually caused by errors in the source text. Problems can also be caused when there are no clear instructions or expectations.

The Do’s and Don’ts

Reviewers should not write comments on a printout and return it by fax, and they should be consistent in their comments. They should also make the changes where they are relevant, or clearly instruct the translator to find out where else to implement a certain change. Further to this, reviewers should restrict themselves to technical contents and should not worry about style issues. Of course, if the translation has many errors, the reviewer should stop work and the translation should be sent back to the translator who has not carried out a professional job.

Reviewers should not add information; this prevents the various language versions from having different content, which is either illegal or may lead to legal issues. If reviewers do have the urge to add information, this tends to mean they don’t like the source text. However, during the translation review phase, it is probably too late to change the source text, but if the shortcomings in the source texts are serious enough it may be necessary to revise it.

In most pharma companies, the local regulatory affairs department takes responsibility for the review. That said, in many cases RA staff members have a medical or pharmaceutical background, or are specifically trained in regulatory affairs procedures. With such backgrounds it may be difficult to distinguish between a translation that is good, acceptable, poor or unacceptable. In our practice of readability testing, we often see documents that have been very poorly translated; these documents will have been submitted for registration and the question is whether they would survive the linguistic review phase – the quality assessment process by the European or national authorities between day 215 and 229 of the central registration procedure.

For many medical device manufacturers the situation is rather different. Many companies do not have their own affiliates in all the countries concerned, and they rely on a distributor – provided they already have one – to do them a favour in reviewing a translation. Others may have an affiliate, but no member of staff is responsible for performing the review. Also in these cases, reviewing a translation may sometimes be done by a person who is not aware of all the relevant information.

In the pharma sector, review changes are usually entered using tracked changes – a method that works well. Regulators can see what has been changed, and translators can easily follow the changes entered in the original version during regulatory review of the original.

In the medical devices sector, different rules often apply. It is not uncommon to encounter a random mix of handwritten-then-faxed changes, comments in a PDF file, an email describing what needs to be changed, and so forth. The quality of the changes can also be variable: sometimes errors are introduced; terms are changed although they have been agreed beforehand or have been used in previous versions of the document; changes are indicated just once and the next person has to figure out whether they affect the rest of the text; and so forth. In cases where the review is done as a favour, given the process may take a lot of time, it can be hard to hold a reviewer accountable.

How can these Problems be Solved?

There appears to be no single best solution to streamline in-country review. There are several methods and tools that make the work more interesting, and there are recommended best practices. These may include:
  • Formally appointing a reviewer for a specific project, or for a series of projects during a certain period of time, so the work is made part of an employee’s job description
  • Sending reviewers the document in both the source and target languages, rather than assuming that the reviewer will have the English version available. This way you avoid that the reviewer compares a translation with an older version of the original
  • Ensuring the reviewers are aware of what was expected from the translators and, where possible, sending them the pre-approved glossary of terms. That way, the reviewer doesn’t have to reinvent the terminological wheel and should only worry if terms from this list are not used
  • Defining standards so that all reviewers in affiliate offices work in the same way. This should include agreeing on codes to classify the nature of the changes and on how to score errors
The most important recommendation however, is to use a web-based system. These are often very effective, as the system automatically standardises the way in which reviewers provide their comments, and in turn reduces errors. Many document management systems used by larger companies offer version control, making it easy to see who changed what, when and why. For companies without such a system, there are dedicated version control programmes, such as PleaseReview, offering easy-to-use functionality to enter comments in a range of different file formats. Using this type of web-based technology proves to be more efficient and, on top of that, it is also more fun.

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Simon Andriesen is CEO of MediLingua, based in the Netherlands. He is also a board member of the Life Sciences Roundtable at Localization World, a series of high-level conferences about translation and localisation. He has designed a course on medicalpharmaceutical translation and is currently designing a healthcare translation course for aspiring Swahili translators, and is a frequent speaker at conferences about language, medical translation, medical writing and readability testing. Email:

Simon Andriesen
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