Checking MedDRA Terminology

Our teams check your SmPCs and all product information texts for compliance with MedDRA (Medical Dictionary for Regulatory Activities). Specialist translators make sure that the defined MedDRA terms for system organ classes (SOC) and adverse events/effects (AE) are used in all available languages. MedDRA terminology is not yet available in all languages. Therefore, we use reference translations and our own databses from central authorisation procedures in order to check translation of AE in other languages.

Our MedDRA review includes the following services:

  • Frequency data– Review of the nomenclature and classification in all EU languages as well as in Japanese and Chinese
  • System organ classes (SOC) – Review of the nomenclature in all EU languages as well as in Japanese and Chinese
  • Adverse events/effects (SmPC) - Checking official MedDRA terms in Japanese, Spannish, German, French, Dutch, Italian, Czech, Chinese, Hungarian, English and Portuguese.
  • Alignment of the adverse event/effect (SmPC) nomenclature in other languages with the translations of authorised reference texts (e.g.: EPARs)
  • Tables - Review and harmonisation of the presentation of the AEs in all translations
  • Comparison of frequency data in translation with English reference texts
  • PL alignment – Comparison of the list of adverse effects in the PL with the AE list in section 4.8 of the SmPC, with a focus on completeness and frequency.

We will be pleased to help you with the “translation” of the MedDRA terms into patient-friendly language.

Contact us.