The Sector Series: Regulatory Affairs

May 7, 2024 | Business, First Edition Translations, Language, Translation

Of the many types of translation projects the First Edition Translations team takes on, one of the most complex, precise and challenging is assisting Regulatory Affairs healthcare professionals and companies to produce translated documents in support of their work.


What is Regulatory Affairs?

Regulatory affairs is a specialised field within healthcare industries like pharmaceuticals, medical devices, biotechnology, clinical trials, among others. It involves ensuring that products comply with regulations set by government agencies in order to protect public health. Regulatory affairs professionals are responsible for navigating complex regulatory landscapes, obtaining approvals, and ensuring ongoing compliance with laws and regulations.


Why are Translation Services central to Regulatory Affairs?

Anything related to the approval and compliance of medical devices, pharmaceuticals, clinical trials, includes translating documents such as product labels, package inserts, clinical trial protocols and dossiers, regulatory submissions, marketing materials and correspondence with regulatory authorities will need translating for exporting into different markets.

For example, in the European Union (EU) and the European Economic Area (EEA), certain healthcare products are granted marketing authorisation through a process known as the centralised procedure (CP). Subsequently, essential documents like the product information (PI) need to be translated into all 24 official languages of the EU and EEA.

These translations, provided by the marketing authorisation holder (MAH), undergo scrutiny and approval by the respective EU member states. This comprehensive review and approval process, involving all 24 languages, is referred to as the linguistic review procedure. It applies not only to initial product approvals but also to post-approval modifications.

And this is only for the EU market, regulatory affair specialists who want to export beyond the EU, need to look into other languages and bear in mind different rules, templates and documentation.


Why is accurate translation so important, particularly in this context?

Accuracy in translation services is our number one priority, no matter what sector we’re working with at the time. For the regulatory sector, translation accuracy is particularly prioritised to ensure:

  1. Patient Safety: Incorrectly translated medical information can lead to misunderstandings or misinterpretations by healthcare providers or patients, potentially resulting in medical errors, adverse reactions, or ineffective treatment.
  2. Regulatory Compliance: Regulatory agencies require accurate translation of product information as part of the approval process for healthcare products. Failure to comply with translation requirements can result in regulatory delays or rejection of marketing authorisation.
  3. Legal Liability: Inaccurate translation may lead to legal issues for pharmaceutical companies or healthcare providers if patients are harmed due to misunderstandings or errors in translated documentation.


The First Edition Translations team prides itself on being a trusted translation agency to undertake the widest range of translation projects for this sector.

Find out more about the various projects and sectors we specialise in – call us, drop us an email or visit us in Cambridge, UK.