The role of mpü in EMA submission

The European Medicines Agency (EMA) is the main regulatory authority for all registration procedures for medicinal products.

The registration procedure involves the entire life cycle of a medicinal product and includes

  • Research and development
  • Phase I-III clinical trials
  • Marketing authorisation and market launch
                      

As a DIN EN ISO 17100 and 9001 certified language service provider, mpü has a reputation for reliability throughout the translation workflow in accordance with EMA requirements and quality assurance standards.


Translating for EMA approvals

To demonstrate the efficacy, safety and quality of a medicinal product, the EMA’s strict requirements call for

                      

qualified and specialised technical translations for seamless registration procedures.

We are very familiar with the process and know what needs to be done - when translating specific regulatory documents

  • Summaries of product characteristics (SmPCs) using technical language
  • Patient information (PLs) using lay terms
  • Labels
  •  
    in all registration procedures:

    • CP (centralised procedure)
    • DCP (decentralised procedure)
    • MRP (mutual recognition procedure)
    • NP (national procedure)
    • Variations

    PREPARATION AND RELIABILITY WITH THE MPÜ TRANSLATION PROCESS

    In order to ensure that your documents are prepared for this process in the best way possible and that any annoying delays are avoided our experienced Regulatory Affairs and Labelling Translations team will support you throughout the process with the following options:

    • Consultation to establish an efficient and reliable translation process with various labelling quality assurance reviews, including software-supported processes and national reviews where necessary
    • Various service packages available depending on the procedure or process.
    • Translations, revisions and technical reviews of all the required languages by regulatory affairs specialists, medical translators and language experts, exclusively native speakers
    • Quality assurance (QA) in all languages with special QA processes and tools
    • Well-qualified and highly trained project managers
    • Consistent quality and terminology as well as compliance with the regulatory requirements for current and future projects thanks to the various options for using translation memory tools, term bases and QRD and quality assurance tools
    • Adaptations to reflect the current QRD template versions and reviews/proofreading of existing translations can be completed prior to the completion of the application assessment or the Positive Opinion in preparation for the next step.

    Timelines

    To make sure you do not miss the deadline for submitting all documents in the national languages after receiving a Positive Opinion (CP) or after the MRP/DCP approval, we recommend starting the translation process of the source texts or incorporating changed text components into the national language documents as early as possible preferably from the day of submission of the application for marketing authorisation or the variation application or the variation notification.

                          

    The 5-day period after a positive opinion (CP) or after DCP/MRP approval should be reserved for making last-minute changes only.

    All regulatory requirements are taken into account

    • EMA QRD templates plus Annexes I–IV and Appendices I–V
    • National templates such as BfArM, Swissmedic and others
    • EDQM standard terms
    • Lay terms in PL (MHRA, AGES
    • Excipients guidelines
    • Non-standard abbreviations
    • MedDRA terminology (mpü database)
    • MedDRA side effects and system organ classes
    • Blue box requirements – adaptation
    • Synchronisation/creation of documents for different product strengths, routes of administration and dosage forms
    • Formatting based on EMA QRD conventions, national requirements or customer specifications
    • Preparation of Member State versions

    Linguistic Review

    The importance of having a technically accurate translation when marketing medicinal products in the EU is highlighted by the requirement to have a linguistic review.

    Services provided by mpü:

    • Handling communications with regulatory authorities
    • Incorporating content and linguistic feedback from regulatory authorities for centralised EU marketing authorisation procedures

    Other services

    CREATION

    Compliance with all regulatory requirements

    • Originator adaptation
    • PL writing
    • PL-SmPC: Consistency check
    • PL-SmPC: QRD adaptation
    • PL: Patient friendliness revision
    • Layout adaptation to customer specifications
    • Harmonisation of labelling texts

    READABILITY COMPLIANCE

    proof of readability and legibility

    • PL adaptation and updating
    • PL readability user tests
    • Bridging reports
    • Focus tests