3 Important Things to Consider when Planning your Centralised Authorisation Procedure
The MAA process is one of the most important and exciting initiatives for a pharmaceutical company or biotech. While the EMA’s centralised authorisation procedure has provided streamlined access to the European market, it can be a daunting process. As part of the centralised procedure, sponsors are required to provide translations of the SmPC, PIL, and label annex for 24 official languages of the European Union, according to very structured timelines and formatting specifications. In order to avoid potential missed deadlines or cumbersome back and forth, remember these best practices when planning your next submission:
1.It’s never too early to engage your translation partner.
Although the translations aren’t required for submission or review until fairly late in the overall process, it is best practice to begin translation using the Day 121 versions of the English files. At this stage, the files are mature enough that significant rewrites are unlikely, and completing initial translations across all languages in a non-rushed manner is prudent. From that point, each opinion and review stage will require that the translations receive minor updates, both to the English source file and to the translations themselves by local authorities. This is easily accomplished during the tight windows for edits within the submission timeline. In order to be fully engaged with a translation provider and ready to work by D121, it is imperative to begin planning conversations with translation partners by the D120 clock stop period at the latest.
2.Develop a review strategy.
Depending on your company’s geographic footprint and resources, you may wish to have an internal translation review using local regulatory staff. While it is not a requirement to conduct an internal review, many organisations choose to, given the importance of the MAA process to their commercial goals. Some companies with larger resources choose to review all languages, others review only a few languages, and some do not review at all. When operating under urgent timelines with sensitive content, an efficient review process will ensure maximum value-add from your reviewers with a minimal investment of their time. There is no “one-size-fits-all” approach to linguistic review of the translations, but speaking with your translation partner can help you identify the approach that will be the most efficient fit in each case.
3.Establish a process for artwork.
Working toward commercialisation inevitably includes creative content like a folding PIL and artwork for the labeling/packaging itself. Many sponsors engage with a creative agency on launch material creation, which often includes label schematics created in programs like InDesign. From there, your translation partner will receive the English design files—fonts, graphics, colors, templates—either from the agency or from you directly. Approved translations from the final SmPC Annex IV & PIL should be inserted into these templates.
With any project, translation-related or not, clear communication is key. And this applies to all aspects of partnership: open lines without the fear of asking questions, full transparency into pricing (particularly in regard to revisions), insight into resourcing, and a plan for review. Once you have selected a language services provider, the mutual goal should be to move away from client-vendor mentality, and move toward becoming extensions of the same team working toward the same goal. To learn more about establishing a partnership with TransPerfect’s labeling team, please reach out to regulatory@transperfect.com and we’d be happy to discuss your upcoming submissions or lend ideas for best practices.
