The use of radioactive substances or ionising radiation for medical research purposes (hereinafter: radiation applications) may be subject to approval in accordance with Section 31 of the Radiation Protection Act (Strahlenschutzgesetz, StrlSchG) or the submission of a notification in accordance with Section 32 of the StrlSchG. If such radiation applications are to take place in the context of a clinical trial of a medicinal product or a medical device, then the radiation approval application or notification process will be integrated as of 1 July 2025 into the application or notification process for the clinical trial itself via the following platforms:
| Regulatory scope of clinical trials | Medicinal products | Medical devices |
|---|---|---|
| Legal basis | Radiation application in the context of a clinical trial within the meaning of Section 4 Subsection 23 of the Medicinal Products Act (Arzneimittelgesetz, AMG) | Radiation application in the context of a clinical trial within the meaning of Article 2 Number 45 of Regulation (EU) 2017/745 or in the context of another clinical trial within the meaning of Section 3 Number 4 of the Medical Device Law Implementation Act (Medizinprodukterecht-Durchführungsgesetz, MPDG) |
| Application portal | CTIS | DMIDS |
| Submission of application/notification for radiation application | With submission of the clinical trial application in Part II (Section N_Suitability of Facility), CTIS | With submission of application/notification of other clinical trial |
| Further information on submission |
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| Regulatory scope of clinical trial | Medicinal products | Medicinal products | Medical devices
| Medical devices
|
|---|---|---|---|---|
| Procedure Type According to the Radiation Protection Act | Radiation application requiring approval (Section 31 StrlSchG) | Radiation application requiring notification (Section 32 StrlSchG) | Radiation application requiring approval (Section 31 StrlSchG) | Radiation application requiring notification (Section 32 StrlSchG) |
| Responsible for specifics of radiation applications | BfS + responsible Ethics Committee | responsible Ethics Committee | BfS + responsible Ethics Committee | responsible Ethics Committee |
| Information on required documents regarding radiation application | AKEK: Medicinal product testing (German only) | BfS: Application for authorisation (German only) | AKEK: Medical device testing (German only) | |
| Formally responsible for radiation applications | BfS | Paul-Ehrlich-Institut or Federal Institute for Drugs and Medical Devices (BfArM) pursuant to section 77 of the AMG | BfS | BfArM |
The following information must be abided and applies to clinical trials regardless of whether they are handled by the Paul-Ehrlich-Institut or the BfArM.
If, in addition to the approval of the clinical trial in accordance with Regulation (EU) 536/2014, an approval application must also be submitted in accordance with Section 31 of the StrlSchG, it should be submitted as part of the CTR submission in the CTIS. It is therefore essential that the cover letter clearly states that the applicant is applying for approval in accordance with Section 31 of the StrlSchG (see also Section 31a StrlSchG). All required documents must be uploaded in accordance with Section 31a of the StrlSchG to the CTIS in Part II (Section N_Suitability of Facility). The BfS provides further information on the naming conventions of these documents on its website. The BfArM will inform the BfS as well as the responsible ethics committee when an application has been received.
If a modification notification is submitted in CTIS for an approval that has already been issued in accordance with Section 31 of the StrlSchG before 1 July 2025, the following instructions must be followed:
The cover letter must state if an approval in accordance with Section 31 of the StrlSchG has been applied for only as the result of modifications in the context of a substantial modification. The required documents must be uploaded in Part II (Section N_Suitability of Facility). When a substantial modification notification is submitted in CTIS, an additional email must be sent to ctr@bfarm.de stating that it is an approval procedure in accordance with Section 31 of the StrlSchG.
If, in addition to the approval of the clinical trial in accordance with Regulation (EU) No. 536/2014, a notification must also be submitted in accordance with Section 32 of the StrlSchG, it should be submitted as part of the CTR submission in the CTIS. It is therefore essential that the cover letter clearly provides information on the notification procedure in accordance with Section 32 of the StrlSchG (see also Section 32c StrlSchG). Information on the involvement of any radioactive substances or ionising rays must be included as well. All required documents must be uploaded in accordance with Section 32 of the StrlSchG to the CTIS in Part II (Section N_Suitability of Facility).
A decision on the notification procedure pursuant to Section 34a of the StrlSchG (restrictions, time limitations or conditions) or pursuant to Section 34 of the StrlSchG (prohibition) is communicated to the sponsor via a posting in CTIS.
If a modification notification is submitted in CTIS for a notification that has already been submitted in accordance with Section 32 of the StrlSchG before 1 July 2025, the following instructions must be followed:
The cover letter must state if a notification procedure in accordance with Section 32 of the StrlSchG has been initiated only as the result of modifications in the context of a substantial modification. Information on the involvement of any radioactive substances or ionising rays must be included as well. The required documents must be uploaded in Part II (Section N_Suitability of Facility). When a substantial modification notification is submitted, an additional email must be sent to ctr@bfarm.de stating that it is a notification procedure in accordance with Section 32 of the StrlSchG.
Email: ct@pei.de
Updated: 25.06.2025
