3 common translation processes required by regulators:
- During the label change process, regulators require the science team to mark all requested amendments in the original submission using the “Track Changes" and “Comments" features in Microsoft Word.
- The applicant must prove that all changes in the source documents have been adequately reflected in each of the targeted languages, again using the “Track Changes" and “Comments" features in Microsoft Word.
- The regulators require further proof that no other portions of the text have been altered in any way.
Managing changes in this mandated way creates major difficulties and pain for labeling managers and staff. However, the right multilingual labeling technology can eliminate many of the pain points. The key is finding a solution that is well-matched to the unique processes required by pharmaceutical regulators.
5 features to look for in a multilingual labeling solution:
#1 – Support for Tracked Changes and Comments
Make sure the technology can handle Microsoft Word-based tracked changes and regulator comments in the source and target languages. This would include:
- Documents that have been amended using Tracked Changes
- Internal review using Tracked Changes
- Regulator review of the target language file, with and without Tracked Changes
- Preparation of file bundles going into regulatory review (including the Microsoft Word source and target documents, with and without Tracked Changes)
- Toggling Tracked Changes across source and target content segments to see different versions (original, final, final with markup)
#2 – Automation to eliminate manual tasks and tracking challenges
Look for a system that automates the translation process, supports and manages all the necessary workflows, and unburdens stakeholders from manual tasks like preparing, dispatching, tracking and routing work requests.
#3 – Protection of unchanged text and formatting
You’ll need a system that knows to automatically lock down portions of the text and formatting during translation and all review cycles – content that shouldn’t change or be manipulated in any way.
#4 – Content Reuse
To improve translation quality and consistency, and to lower costs, validate that the solution can leverage centralized translation memory and terminology management. With these features, you’ll guarantee maximum consistency/quality and only pay for translating brand new content.
#5 – Streamlined review and linguistic quality assurance
Simplify the review of translated documents by both internal and external experts with a solution that can automatically create a Microsoft Word document for reviewers to capture their feedback with Tracked Changes and Comments. Post-review, the system should automatically capture and reflect all final amendments back in the central system, forming the basis for all future work.
By adopting a multilingual labeling solution with these key features, you’ll avoid the nightmare associated with the very arduous process of multilingual drug labeling. At SDL, our innovative Pharma Labeling Solution is built to eliminate the challenges associated with translating labeling text and getting it approved. It is the only automated solution available today that handles Microsoft Word-based labeling and review procedures.