After looking at medical translations in last week’s blog post, we thought we’d dive in a bit deeper and take a look at the world of pharmaceutical translations. As they are so much more specific, pharmaceutical translation services have their own special sets of rules, which is what we’d like to cover today.
Introduction to pharmaceutical translations
Pharmaceutical translations can have a direct impact on your life. Imagine taking part in a clinical trial and not being able to understand the information properly. Or worse, taking part in the trial thinking you’re doing one thing and then you find out that there was an error in the information due to a poor translation. Other more serious consequences don’t bear thinking about, which is why finding a trustworthy partner is really of paramount importance.
Pharmaceutical translation compliance
One thing you need to be aware of in regard to pharmaceutical translations is that they’re very heavily regulated. In addition, in order to get medicines registered internationally, it will be necessary to demonstrate compliance to bodies such as:
- The Food and Drug Administration
- The European Medicines Agency
- Ethics Committees
- Institutional Review Boards
As mentioned earlier, there are a number of regulations that your translations will need to comply with. As for medical devices, each country regulates pharmaceuticals and has their own special sets of rules. In the EU, it is required to comply with the regulations of the European Medicines Agency and its Committee for Human Medicinal Products, in addition to local regulations.
The scope of pharmaceutical translations required can range from those for phase I clinical trials, to phase II and licencing, etc. Moreover, a number of agencies also have their own requirements for font size and colours.
As you can see, a lot more work needs to go into pharmaceutical translations than might first meet the eye. Failure to have your translations in order can really impact upon the success of your trials and drug registrations, etc. which is why it really is worth using experts who can help guide you through the whole process.