Translation for regulatory submission-pharmaceutical translations

Before a new drug can enter the market, pharmacuetical manufacturers must fill in a drug submission application with the relevant regulatory agency, for review and approval.
Within the European Union, the EMA (The European Medicines Agency) requires a marketing Authorization Application launched via the Centralised Procedure (CP).

There are three main types of documents the EMA  requires for translation, for regulatory submission purposes:

  • Product Information Leaflets (PIL)

  • Labelling

  • Summary of Product Characteristics  (SmPC)

Translation of Regulatory Documentation

The new drug applicant will produce a high-quality English draft for its PILs, SmPC and labelling, and will ask its translation partner to translate this draft into all official 23 languagues of the EU.

It is very important for pharma producers and CROs to chose reliable translation partners with specific expertise in the pharma and regulatory affairs fields.

Pharma Translation Services for EMA Centralized Procedure

Our medical translation team translates for private pharma companies, CROs, and regulatory bodies (such as EMA, ECHA etc)

Paspartu assists Marketing Authorization Holders, medium-sized and major drug producers in Europe and USA in translating their new pharma products into all European languages for marketing authorization purposes.

The EMA reviews the English version of the package leaflets in the so-called pre-opinion phase. Subsequently, Paspartu translates drugs approval/ rejection decisions, recommendations for use, standard operating procedures as well as various scientific reports commonly required by the EMA.

Translation of Product Information for National, MR, DC Procedures

Apart for translation for the Centralised Procedure, Paspartu also performs translations required for national, MR and DC procedures.

Specialised translation services for PILs, SmPCs, labelling

Main translation services:

    • Perform a readability testing on your PILs, to ensure that the content can be read and understood by lay patients
    • Draft a report on any suggested changes that should be implemented in the source file, as this is a legal requirement of EMA for certain categories of medicines in Europe
    • Translate your English draft into the 23 EU languages within the required deadline
    • Comply with/ update your translation to newest QRD template, file naming conventions, linguistic preferences and reference material
    • Apply specific translation memory technology to identify repeated content and render terminology consistently

    Check our translation projects with leaders in pharma and medical technology here-

Translation and linguistic validation