| Simon Andriesen at MediLingua BV warns that some translation QA methods may foster a false sense of security
Patient information leaflets for medicines, user instructions for medical devices and instruments, a variety of documents used in clinical trials – all need to be translated. European Union (EU) directives regulating many aspects of such documents require availability of these documents in the official language of the country where these products are marketed. And this does not only concern the member states of the EU. Non-EU countries where translation is a must, such as Russia, Turkey, Japan and China, to name but a few, have adopted similar laws.
This article asks what needs to be translated and why, and if there are any required translation quality levels. Then we will explore how translation quality is usually assessed and how effective these methods really are.
WHAT NEEDS TO BE TRANSLATED AND WHY?
Medicines
The European Medicines Agency (EMEA) and the various national medicines evaluation agencies require that the summary of product characteristics (SMPC), the patient information leaflet (PIL), and the packaging and labelling texts have to be available in the local language. A manufacturer cannot apply for registration without handing over the translated versions of these documents to the European or national regulatory authorities. The European Medicines Agency (EMEA) and the various national medicines evaluation agencies require that the summary of product characteristics (SMPC), the patient information leaflet (PIL), and the packaging and labelling texts have to be available in the local language. A manufacturer cannot apply for registration without handing over the translated versions of these documents to the European or national regulatory authorities.
Medical Devices
The EU Medical Devices Directive (MDD, Directive 93/432/EC) specifies all the requirements that medical devices must meet. The Directive has been transposed into national laws and all EU countries (and many non-EU countries) now require translated versions of instructions for use (often referred to as IFUs), packaging and labelling. The IFU must cover all instructions for the user to use the device safely.
Clinical Trials
The EU Directive concerning clinical research (Directive 2001/20/EC) is less strict in specifying the requirements concerning language, but most countries have local regulations that require all information for patients to be translated. In many countries the study protocol also has to be available in the local language. Even if this is not a strictly legal requirement, often bodies such as the Medical Ethical Committee (MEC) of the study centres will require translation of documents as a condition for their participation. |
