How to plan regulation-focused medical translation projects

How to plan regulation focused medical translation projects

In medical and pharmaceutical content, translation must support both accurate understanding and full compliance with the guidelines and regulations of competent authorities.

Key questions at the planning stage

Which guidelines and reference documents are issued by the target country medicines agency or health authority?
What level of consistency is expected between SmPC, package leaflet, label and packaging texts?
Is there an approved internal terminology list for core medical and regulatory terms?
Are previously approved reference texts available for translators and reviewers?

Recommended project approach

With the right framework, it is possible to create a predictable and defensible language standard that supports both patient safety and inspections.

Map all relevant regulations, guidelines and agency templates.
Design a terminology database that reflects this framework and define an approval workflow.
During translation, revision and quality control, compare each new version not only with the source but also with previously approved materials.
Add approved translations to a reference library for future submissions and variations.

Additional tips to reduce regulatory risk

Create dedicated checklists for dosage instructions, warnings and contraindications.
Align abbreviations and pharmaceutical terms with those used in official guidelines.
Test text length and legibility for space constrained packaging.
Apply clear version control to all translations used in submissions and variations.