Feb 4

Linguistic review of SmPCs, Labels and PILs in the marketing authorisation process

What comprises regulatory documentation
All pharmaceutical products which receive marketing authorisation in the EU are to be accompanied by specific regulatory documentation. This includes summaries of product characteristics (SmPCs), patient information leaflets (PILs) and labels. SmPCs are official descriptions of drugs. They include information such as: pharmaceutical form, indications, method of administration, pharmacological properties, etc. Product leaflets also cover some of this data, but their main role is to provide intelligible and user-friendly information to patients so they tend to be less specialised in terms of medical terminology. Labels are used for drugs’ packaging.

QRD templates and the linguistic review
A marketing authorisation applicant (or MAA) is responsible for preparing such regulatory documents strictly in accordance with the Quality Review of Documents (QRD) templates which can be downloaded from the European Medicines Agency’s website.

Just like new drugs are evaluated for safety and efficacy in clinical trials, regulatory documents have to go through the EMA’s linguistic review before there’s a final version that will be used as a source text for translation into the official languages of the EU.

From Day 1
The application process starts with a review at Day 1 and finishes at Day 277 when the European Commission makes a final decision on whether to grant a marketing approval. At Day 1, the MAA submits only the English language version of an SmPC, PIL and Label which then go through a detailed check. When completed, the MAA receives comments that are to be implemented into the new version. This happens at Day 120 and the applicant has to respond to all queries or implement all comments by Day 121 so the deadline is short.
The Agency then verifies the revised documents and by Day 155 forwards them for a further review to all QRD group members and to representatives of Patients’ and Consumers’ Organisations.
By Day 157 at the latest, the applicant receives QRD comments and depending on the quality of the English texts, the Agency might want to agree a meeting between the Agency’s employees, Member States’ representatives and, optionally, with the applicant’s representatives. This meeting focuses on linguistic, stylistic and QRD template-related issues. At this point, the group determines if the English version is now harmonised.

Crucial five days
At Day 210, after checking if all comments have been implemented (and, most importantly, after conducting a scientific assessment of the drug), the Agency adopts (or not) a favourable opinion and the English version of an SmPC, PIL and Label is considered final. This is also where the catch is, because all 23 language versions are to be submitted by Day 215, so this gives the applicant JUST five days to submit all translations. A set of three documents can vary in length, but in majority of cases it’s well above 10,000 words. In light of this, EMA advises all applicants to start working on translations before Day 210, for example after Day 165, which would be English version no. 2 or later.
Commencing the translation before Day 210 means that a translator will work from a draft English text, and will have to be available and ready to implement any changes that may appear at Day 210 or before, if any further amends are needed in the meantime.
Translations submitted at Day 215 will be reviewed by Member States and co-ordinated by the country’s QRD group member. By Day 229, members will send their comments to the applicant, presenting an overall opinion on the quality of the translations.
Then, the marketing authorisation holder has until Day 235 to implement all comments in the track changes mode and to submit a revised version to the Agency.

Finalising the translations
If the translations are of a good quality and the applicant has been thoroughly following the Agency’s suggestions, at Day 237 the Agency sends final documents and translations to the European Commission. However, if there are any issues, this long process can be further delayed.

Considering that it takes about 13 years for a particle to become an approved drug, any setbacks are highly undesired.

The Commission, after following its internal procedure, issues the final decision regarding granting a marketing authorisation at Day 277. That’s a pretty long process, isn’t it? The decision is then valid for five years and has to be renewed before the approval expires.

Conclusions for the translator
The translator of such regulatory documentation must be:

  • Flexible and available during the application process.
  • Familiar with QRD templates.
  • Vigilant to report any source text issues immediately.
  • Able to conduct thorough research in a short timeframe.
  • Willing to engage in dialogue with the Member State’s QRD group member.
  • Timely – late deliveries are not an option!

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