• Revised CTIS Sponsor Handbook release

    | 07 July 2025 |

    The revised Sponsor Handbook for the Clinical Trials Information System (CTIS) will be published on the EMA website on Wednesday 9 July 2025. On the same day, a dedicated CTIS bite-size talk takes place at 15:30 CEST.

  • The Danish Medicines Agency requires bioequivalence data in a better data format

    | 03 July 2025 |

    In future, the Danish Medicines Agency will request that data from bioequivalence studies be submitted in an additional data format to that used today. Businesses applying for approval of new medicines or submitting variation applications will be required to submit data in CDISC format from 1 September 2025.