As of 1 January 2026, sponsors will not be charged a fee for the Clinical Trial Regulation safety assessment and ethics committee assessment when a clinical trial application must be resubmitted due to technical issues in the Clinical Trials Information System, provided that these issues occurred after validation.
In exceptional cases, technical issues in the the Clinical Trials Information System (CTIS) require the resubmission of a clinical trial application, even after validation. As of 1 January 2026, sponsors will not be charged a fee for the CTR safety assessment and ethics committee assessment when a clinical trial application must be resubmitted due to technical issues in the Clinical Trials Information System. This fee exemption applies only if the content of the resubmission package is identical to the validated submission package of the original application.
How to request the fee exemption?
After submitting your resubmission, you must request the fee exemption by sending an email to ct.rd@fagg-afmps.be with the subject line ‘xxxx-xxxxxx-xx-xx_resubmission_invoice_exemption’.
The e-mail should include:
- the application ID;
- a confirmation statement that the resubmission package is identical to the original one after validation (please mention the EU CT number, application ID and submission date of the original one), with no substantial, non‑substantial, or typographical changes. Only elements that must be updated for the new submission, such as study numbers, version numbers, and dates, should be adapted.
- evidence that the resubmission is due to CTIS technical issues, such as documentation that the original application was lapsed or withdrawn at the request of the EMA, accompanied by the corresponding EMA ticket mentioning the EU CT number, application ID and submission date and confirming the technical problem.
More information
EU Regulation 536/2014