Translation and control of product information during European procedures
The long process leading to the availability of a medicinal product on the market includes a whole set of steps aimed at ensuring its quality, safety, and efficacy in view of its marketing authorisation. One of these is the so called drug linguistic review, a control of the information that come along with the products, made available to doctors, pharmacists and patients upon its marketing.
In fact, when a medicinal product is authorised at European level, via a centralised procedure, there is a set of documents to be submitted during such procedure that have to be translated into the 24 official languages of the European Union and Economic European Area.
The future Marketing Authorisation Holder is responsible for the submission of such documentation, however the authorities of the Member States and of the EEA countries have the task to revise, for instance, the Product Information (SmPC, Patient’s Information Leaflet and Labelling), checking the congruity of the translations and the presence of the provided national requirements.
This is a time-consuming process requiring many resources, that includes several steps requiring the cooperation of the central authority (EMA) with the national authorities.
The tasks of the national authorities
The European Medicine Agency (EMA) is the main actor of a centralised procedure; therefore, English is the language used to draft the relevant documentation.
The CHMP (Committee for Medicinal Products for Human Use), made of representatives of each Member State and a maximum of five EU experts in the pertaining sectors, deals with the assessment of the procedure. The intervention of national authorities is still necessary to assess the product information accompanying the medicinal product during its marketing in the different countries.
This information is drafted in English following the relevant guideline provide by the working group on Quality Review of Documents (QRD), and then translated, by the MA holder, into all official EU and EEA languages. The “linguist review process” provides for that the QRD working group collects any comment from the national authorities, that have to check such documentation.
All steps of the language review
The linguistic review process of the product information of a medicinal product undergoing a centralised procedure goes through a series of steps, that should be performed within a specific CP timeframe, namely between Day 215 and Day 229.
When, at Day 210, the CHMP sends a positive opinion to the Applicant, the texts of the Summary of Product Characteristics, Package Information Leaflet and Labelling, concomitantly received, can be translated to undergo the linguistic review.
Clearly, translations are generally ready before this deadline, to be sure that the timeline provided for by the European regulations are complied with: it would not be possible to complete such a work in 5 days only.
The submission of the final English texts and the relevant translations into the 24 official European languages is in fact provided for at day 215.
This short period of time is however sufficient to control and integrate the texts already translated against the corrections/comments that the CHMP can make during the procedure.
It is worth to remind that the translation into the 24 official languages concerns not only the product information, but also Annex IV (information on any conditional authorisation, similarity, derogation, marketing protection), Annex 127a (any conditions or restriction on the safe and effective use of the medicinal product to be implemented by the Member States) and Annex A (summarising the medicine data, i.e. EU MA number, name, strength, pharmaceutical form, route of administration, immediate packaging, concentration, pack size).
For these document EMA has provided the relevant QRD template. Moreover, the Day 215 checklist and QRD form 1 will allow Member States to keep track of the quality of the translations.
The linguistic review
The translations received at Day 215 will be, in turn, forwarded by EMA to the individual national authorities to undergo a linguistic review, that shall be concluded within Day 229; this is the deadline when the Applicant can expect to receive the reviewed texts.
The latter has then time until Day 235 to implement the amendments requested by the authorities and send back the final texts to EMA to conclude the procedure.
In order to avoid any surprise during procedures, with potential delays that can affect repercussions on the launch of the products, translation must be accurate and take into account the guidelines and templates circulated by the authorities.
The use of a translation agency and professional translator who specialise in scientific and pharmaceutical translations can prevent this kind of issues and ensure a smooth progress of centralised procedures.
Written by: Maria Pia Felici
Foto di StartupStockPhotos da Pixabay
