Bringing your product to multiple markets globally confers many benefits, but also many challenges. As I’ve discussed in the past, regulatory authorities want more data, they want it quickly, and when filing in several markets, some regions have different – often more stringent – demands than others.
By Sunshine Bruce, MBA, Customer Success Executive, Life Sciences, CSC
Requirements around labeling are every bit as complex, if not more so given the translation challenges. From the moment your product – be it a drug or device – is approved in one market to it receiving approval on other markets, the labeling text will invariably have to be adjusted to some degree. This is where specific regional and country requirements around language and translations become onerous.
Unfortunately, many companies are forced to handle these labeling changes manually, working with teams of people to meet the language requirements, and finding and updating phrases or artefacts. At the same time, those teams must manage version control and content tracking to compare the source text – typically English – of the old and new versions.
On the Clock
Regulatory authorities have a very tight turnaround for managing changes to the labeling text before they grant marketing approval, generally between 4 and 7 days to make the necessary changes in the language or languages required. In the European Union with its 27 countries, that means 24 different languages, and even at a country level some require more than one language translation (for example, Belgium requires labeling to be translated into the three official languages of the country – Dutch, French and German).
Once in the post-marketing phase when the labeling text has been approved, released and printed, you are still required to comply with regulation changes and get mock-ups of the outer packaging and immediate packaging approved, etc.
Having an artwork management solution or system removes the manual effort to support translations and other labeling components, and enables content to be reused more efficiently and easily rather than having a writer or regulatory person constantly review all the documentation as it’s being versioned up.
What Does That Mean in Practice?
Let’s take an example of a product that initially had very tight market authorization, perhaps it could only be administered in a hospital. However, after further clinical trials, the product’s label is extended, and it can now be administered in broader healthcare settings. A manual approach would require a team to search and update all that phrasing and ensure it is carefully translated into other languages so the meaning is exactly the same.
Another example might be similar sounding terms that have quite different meanings, such as a sterile solution versus a sterilized component. Translating that into other languages adds another element of complexity because of the nuances in the language, for example is the word feminine or masculine in German or French?
But if you have an automated artwork solution and took the steps to standardize terminology, it’s much easier to manage those type of changes and ensure consistency across similar products. This is not only much more time efficient than having multiple people manually work through spreadsheets, but also far more consistent since terminology isn’t open to individual interpretation.
Learn more about handling translations in labeling and the advantages of an artwork management solution during the CSC-Kallik webinar on October 26, 2016 at 11am ET, Leading the Way in Labeling and Artwork Management.