Introduction: staying ahead with proactive SPC translation
In the highly regulated chemical sector, timing is critical. Since the Summary of Product Characteristics (SPC) is a cornerstone of the EU authorisation process, any delay in preparing compliant translations can jeopardise product launches.
One of our clients adopted a proactive approach: instead of waiting for the updated English draft from the European Chemicals Agency (ECHA), the client commissioned us to translate the draft SPC into 23 EU languages plus Norwegian and Icelandic ahead of the BPC meeting. This forward-looking strategy provided a valuable head start and enabled seamless adaptation once the ECHA issued its feedback and set the tight final submission deadlines.
Complexities to overcome
The project’s complexity arose from three main factors: managing translations in 25 languages, meeting ECHA’s tight 5–10 day deadline and navigating ECHA’s unique process, in which the draft SPC is subsequently followed by an updated version.
Our proactive approach
- Early translation: draft SPC translated into 25 languages ahead of the BPC meeting
- Handling ECHA updates: translations revised promptly based on ECHA feedback
- Expert in-country translators: linguists specialised in chemistry ensured technical accuracy aligned with ECHA expectations
- Terminology consistency: a centralised multilingual glossary aligned with ECHA terminology maintained uniformity across all languages
- Streamlined project management: close coordination with the client and rigorous quality checks ensured smooth, on-time delivery despite the tight deadlines
Results
- 25 translations delivered smoothly, even as the source text evolved
- Agility under pressure: early translation of the draft gave the client extra lead time to respond to ECHA updates
- Time efficiency: only updated sections were re-translated, eliminating unnecessary work
Key takeaways
This case demonstrates how proactive SPC translation enables companies to:
- anticipate regulatory challenges rather than merely reacting to them
- manage evolving SPC files efficiently, regardless of whether the changes are minor or extensive
Conclusion
The client’s proactive decision, combined with our specialised SPC translation process, turned a potential regulatory challenge into a smoothly executed success story. By preparing translations ahead of the ECHA updates and applying a flexible update strategy, the project achieved both compliance and efficiency – proving that foresight is one of the most powerful tools in regulatory translation.