Regulatory Compliance in the Pharmaceutical Field
Pharmaceutical localization or translation is not an option; it is a lawful and ethical imperative.
Large numbers of clinical trials are being held in a variety of countries, and it is absolutely vital for
technical, medical and other pharmaceutical documents to be translated accurately in order to make them
understandable for non-English speaking individuals taking part in such trials.
Documents for such trials are required by most nations to be translated so that participants are
able to understand what will be required of them, the procedures of trials, etc. Poor translations could ultimately
lead to serious legal repercussions if an individual feels they were not told about particular aspects of a trial
because they were unable to understand the documents they were asked to sign.
The same naturally applies to the labels on medications that are to be marketed in other countries.
Dosages, warnings, side-effects and storage instructions, for instance, have to be accurate to prevent serious
accidents such as over-doses, individuals taking a medication they should not have because of allergies or other
conditions, etc, must be clearly understandable and correctly translated.
It should never be assumed that English labels can be used - many European and other countries have
laws stating that such labels must be translated into national languages.
The thought of maybe using a bilingual member of staff to do these translations is tempting, but
should be avoided. While they may be excellent in their particular job, they are not trained as translators, may
not have the required knowledge of medical terms in the target language and may thus resort to using free
This may sound like an acceptable idea until one hears about the case where such a tool translated
the 'once a day' dosage of a blood pressure medication into 'eleven times a day'. The consequences of this error
hardly need to be explained.
It is therefore important to use only qualified, specialist medical and pharmaceutical translators
for this kind of translation.
These individuals have undergone years of training and have often also spent years gathering
experience both in translations and in the use of medical and pharmaceutical terminology before specializing in the
This means they have both the linguistic and the medical skills and knowledge to ensure that
translations are accurate, avoiding potentially fatal errors and expensive legal procedures.
In addition, using professional translators provides an assurance that translations will be done in
compliance with specific local laws and regulatory demands. Again, this will protect a company from unnecessary
wrangles in courts.
Regulatory rules and laws exist to protect both the public and companies conducting trials or
marketing pharmaceutical products. Flaunting these laws may not only finish off a company, it could also cost
lives. This is not a prospect any reputable company would like to face.
To ensure they never have to, they need to employ professional translators for all their documents,
labels, etc, as this will give them a guarantee that they will remain in compliance with the necessary laws and