Clinical trials are an important step during drug development, leading towards marketing authorisation and thus, market access. According to §40 German Drug Law / §7 GCP ordinance, clinical trials have to be approved by the responsible competent authority (CA). Recently, both German CAs (the Federal Institute for Drugs and Medical Devices (BfArM) and the Paul Ehrlich Institute (PEI)) announced that submissions for clinical trials will now be accepted also purely electronically in addition to the well-established paper-based format:

  • In the case of the PEI, this initially applies only to new applications for clinical trial authorisation and all subsequent regulatory activities associated with these studies (e.g. reply to letters of deficiency and substantial amendments).
  • In a second step, purely electronic submissions will also be possible for studies for which applications were previously paper-based and the timing for this is to be confirmed.

As in the past, documents filed electronically must be provided in the folder structure specified by the BfArM/PEI. Submission can be then made via the Common European Submissions Portal (CESP); Eudralink or e-mail will not be accepted. However, submission of documents in the established way (paper/CD) will be still possible.

If you have any questions, please do not hesitate to contact the German EUDRAC office.