The EMA and TVT

EMA and TVT.jpg

This may come as a surprise to Regulatory Affairs professionals of the Pharmaceutical industry, but the European Medicines Agency has been using the Text Verification Tool® (TVT) since 2004!

So, what is it and why is this information relevant for Regulatory Affairs, Labelling and Graphic Designers working in Pharma?

  • The EMA spends a lot of time comparing texts!

And in simple words, that’s what TVT does: load two files (which could be Word/PDF/SPL/AI/TXT etc…), exclude what’s not relevant manually or with a template (ie: QRD template for cartons/labels) press the compare button and the software will show you where the differences are. All the proofreader has to do is accept or reject the difference, and a file with all annotations will be generated with its audit trail report: simple, fast and most importantly error-free.

  • The EMA deals with patient-critical information

One department of the EMA uses TVT to compare the content of leaflets from Parallel Importers to the one already in the destination market. A single mistake means a patient could be put at risk and it also means they are not respecting the original Marketing Authorisation. If you really want to know all the details, here is the SOP from the EMA (and the updated SOP) where they explain more precisely how they use it.

  • The EMA deals with 25 different languages

Although internal resources may be limited, each text has to be equally 100% error free.

  • Why did the EMA initially start using TVT?

The first reason is risk avoidance: the EMA cannot afford to make a mistake as ultimately this could impact patients. The second reason is economical, Canary Wharf employees at the EMA are highly qualified (in ROI terms, understand expensive!) so if an employee can only revise 2 leaflets per hour, the cost is very high. By implementing TVT the Assessor can review many more per hour which significantly decreases the cost, ultimately saving money in the Pharmaceutical industry.  Additionally, as manual text comparison is very tiring, the implementation of TVT helped decrease employee turnover.

  • How much money does the EMA save by using TVT?

There is no official number, however the EMA is actively encouraging Parallel Importers to use TVT by providing a 290€ discount for each annual update notification provided with a TVT report.

  • Is the EMA the only one using it?

Of course not, the ANSM, MHRA and BfArM also use TVT in a similar way, and more than 300 pharmaceutical companies big and small across the World, mostly for their labelling (comparing PDF Artwork against approved Word file).

Do you need help proofreading your regulatory submissions? Try TVT


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