EU regulatory translation

LIFE SCIENCES

We have been providing translation services in the pharmaceutical industry over a decade with our experience and knowledge having placed us as a preferred supplier to translation, regulatory affair and pharmaceutical companies across the world.

Stepping Stone has teams based in every European country and is well positioned to address the many challenging stages of EU regulatory translation.

We are also well positioned to work with translation vendors with little or no experience in this area.

Obtaining Marketing Authorisations

There are a number of routes a pharmaceutical company who is looking to obtain marketing authorisations for their medicinal products within an EU country.

National authorisation

Each country within the EU has its own regulatory agency which authorises Marketing Applications for new products.

If a pharmaceutical company wants to get an approval in several EU countries simultaneously they can choose a decentralised or mutual recognition procedure.

Decentralised

A pharmaceutical company can apply for simultaneous authorisation in several EU countries for products that have not yet been authorised in any EU country.

Mutual recognition

Using this route a pharmaceutical company would first get a marketing authorisation in one of EU countries in accordance with the national procedures of that country. When the approval is received, the company can then apply for marketing authorisations in other EU countries. Rather than conducting their own review these countries will recognise the decision of the first member state.

Centralised

Applications for marketing authorisations in EU are overseen by the EMA (European Medicines Agency) with marketing applications evaluated by the Committee for Medicinal Products for Human Use (CHMP).

The linguistic review process

There are a number of routes a pharmaceutical company who is looking to obtain marketing authorisations for their medicinal products within an EU country.

The following process has been established for new applications and extensions:

At submission and during assessment, only the English language version of the product information is submitted and reviewed (pre-opinion stage).
Translations of the product information (SmPCs, PILs, packaging texts) in all EU languages (including Icelandic and Norwegian) are to be provided for a linguistic review after adoption of the CHMP opinion.
Each translation will be subject to one Member States’ linguistic review, co-ordinated by the national QRD member. QRD members will send their comments directly to the applicant together with an overall feedback on the quality of the translations
The MAH will then have to send the final translations with tracked changes, incorporating the Member States’ comments.
The Agency will check if all Member States’ comments have been implemented before sending the final translations to the Commission.

In view of the short time frame given for submitting the translations, the European Medicines Agency strongly recommends to initiate the translation process well in advance in the pre-opinion stage.

At Stepping Stone we have established teams of in-country translators and reviewers who focus solely on pharmaceutical translations. As they deal with this type of translation on every day basis they are able to deliver high quality translations in a tight time frame.

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Regulatory services