New radiation protection regulations effective July 1, 2025

Effective July 1, 2025, new regulations will apply to radiation protection approvals or notifications for clinical trials.

The use of radioactive substances or ionizing radiation for medical research purposes (hereinafter referred to as “radiation applications”) may be subject to approval in accordance with Section 31 of the Radiation Protection Act (Strahlenschutzgesetz, StrlSchG) or notification in accordance with Section 32 StrlSchG.

Until now, the Federal Office for Radiation Protection (Bundesamt für Strahlenschutz, BfS) had to review the application for approval or notification in a separate procedure in Germany. Of July 1, 2025, the application or notification of the radiation application will be submitted in the same way as the clinical trial itself is applied for. This means that the single-gate approach applies. CTIS is used for clinical trials of medicinal products in accordance with Regulation (EU) 536/2014. The German Medical Devices Information and Database System (DMIDS) is used in the context of a clinical trial within the meaning of Article 2(45) of Regulation (EU) 2017/745 (Medizinprodukteverordnung, MDR) or in the context of other clinical trials within the meaning of Section 3(4) of the Medical Devices Implementation Act (Medizinprodukterecht-Durchführungsgesetz, MPDG).

The objectives of the reform of the Radiation Protection Act by the Medical Research Act (Medizinforschungsgesetz, MFG) are to harmonize and interlink radiation protection law with both pharmaceutical and medical device regulations. In the notification procedure, there is no double review by the BfS and the ethics committee. In clinical trials with medicinal products, the BfS and the ethics committee review the procedure in parallel in a procedure requiring approval. This speeds up the procedure.

Important: The procedures under radiation protection law and under medicinal product or medical device law remain legally independent procedures.

Notification or approval?

The most important prerequisites for a research project to be classified as notifiable are

• The safety or efficacy of a treatment procedure is being tested
• The use of radiation as such is not itself the subject of research
• The use of radiation is a recognized standard procedure for investigating humans
• Only patients with a disease whose treatment is being investigated as part of the research project may be included. This means that as soon as the research project is carried out on healthy individuals, it is subject to approval.
• A new feature is that minors may also be included in the research project. This applies as long as the total effective dose from all radiation applications carried out as part of the research project is not expected to exceed 6 millisieverts per person.
• The research project is
• a clinical trial within the meaning of Section 4 (23) of the German Medicinal Products Act (Arzneimittelgesetz, AMG),
• a clinical trial within the meaning of Article 2 (45) of Regulation (EU) 2017/745 (MDR) or
• any other clinical trial within the meaning of Section 3(4) of the Medical Devices Implementation Act (Medizinprodukterecht-Durchführungsgesetz, MPDG).

Conclusion

Any use of radiation for medical research purposes that is not subject to notification is subject to approval (Section 31(1) StrlSchG).

These include

• research projects involving healthy individuals
• research projects involving minors in which the total radiation exposure resulting from the study exceeds 6 millisieverts per person
• Research projects that are neither clinical trials pursuant to Section 4 (23) of the AMG or Article 2 (45) of Regulation (EU) 2017/745 (MDR) nor other clinical trials within the meaning of Section 3 (4) of the Medical Devices Implementation Act (MPDG). This radiation application for medical research purposes must be approved by the BfS in accordance with professional law (Berufsrecht) pursuant to Sections 31 et seq. of the StrlSchG.

Approval procedure pursuant to Section 31 of the German Radiation Protection Act (Strahlenschutzgesetz, StrlSchG) of 1 July 2025

The following information must be observed and apply to studies processed by both the BfArM or the PEI.

If, in addition to the approval of the clinical trial in accordance with EU Regulation 536/2014, an application must also be submitted in accordance with Section 31 StrlSchG, this should be done as part of the CTR submission in CTIS. For this purpose, it is essential that the cover letter clearly states that an application for approval in accordance with Section 31 StrlSchG is being submitted (see also Section 31a StrlSchG). All necessary documents in accordance with Section 31a StrlSchG must be uploaded to CTIS in Part II (Section N_Suitability of Facility). Further information on the naming conventions for these documents can be found on the website of the Federal Office for Radiation Protection (BfS). The Federal Office for Radiation Protection (BfS) and the responsible ethics committee will be informed by the BfArM of the receipt of the application.

If a substantial modification is submitted in CTIS for which approval has already been granted in accordance with Section 31 StrlSchG before July 1, 2025, then a) this has to be stated in the cover letter and the relevant documents must be uploaded in Part II (Section N_Suitability of Facility) and b) at the same time as submitting the substantial modification in CTIS, an additional email must be sent to ctr@bfarm.de stating that these studies also concern the approval procedure under Section 31 StrlSchG.

If approval pursuant to Section 31 StrlSchG is only requested through changes within the scope of a substantial modification, this must be stated in the cover letter. The required documents must be uploaded in Part II (Section N_Suitability of Facility). At the same time as submitting the substantial modification in CTIS, an additional email must be sent to ctr@bfarm.de stating that this substantial modification concerns the approval procedure under Section 31 StrlSchG.

Further information on the approval procedure pursuant to Section 31 StrlSchG can be found on the homepage of the BfS and the Working Group of Medical Ethics Committees (AKEK).

Notification procedure pursuant to Section 32 of the German Radiation Protection Act (Strahlenschutzgesetz, StrlSchG) of 1 July 2025

The following information must be observed and apply to studies processed by both the BfArM or the PEI.

If, in addition to approval of the clinical trial in accordance with EU Regulation 536/2014, notification in accordance with Section 32 StrlSchG is also required, this should be done as part of the CTR submission in CTIS. It is essential that the cover letter clearly states that an additional notification procedure in accordance with Section 32 StrlSchG is required (see also Section 32 StrlSchG (c)). It must also be stated whether radioactive substances or ionizing radiation are involved. All necessary documents in accordance with Section 32 StrlSchG must be uploaded to CTIS in Part II (Section N_Suitability of Facility).

Further information can be found on the website of the Working Group on Medical Ethics Committees (Arbeitsgruppe Medizinischer Ethik-Kommissionen, AKEK).

A decision on the notification procedure in accordance with Section 34a StrlSchG (condition, time limit, or requirement) or in accordance with Section 34 StrlSchG (prohibition) will be uploaded to CTIS and forwarded to the sponsor in this way.

If a substantial modification is submitted in CTIS for which a notification in accordance with Section 32 StrlSchG already existed before July 1, 2025, then a) this must be stated in the cover letter, including whether radioactive substances or ionizing radiation are involved, and the relevant documents must be uploaded in Part II (section N_Suitability of Facility), and b) at the same time as submitting a substantial modification in CTIS, an additional email must be sent to ctr@bfarm.de, indicating that these studies also affect the substantial modification procedure under Section 32 StrlSchG.

If a notification procedure pursuant to Section 32 StrlSchG is only required as a result of changes made in a substantial modification, this must be stated in the cover letter. Furthermore, information must be provided as to whether radioactive substances or ionizing radiation are involved. The required documents must be uploaded in Part II (Section N_Suitability of Facility). At the same time as submitting the substantial modification, an additional email must be sent to ctr@bfarm.de, stating that this is a notification procedure pursuant to Section 32 StrlSchG.

Radiation applications in combined clinical trials (clinical trials submitted to both CTIS and DMIDS)

For combination studies – clinical trials submitted to both CTIS and DMIDS – only a single radiation protection notification according to § 32 StrlSchG (Strahlenschutzgesetz (German Radiation Protection Act)) or an approval according to § 31 StrlSchG is required. This notification or application can be submitted either via CTIS or DMIDS. We recommend selecting the platform based on the specific requirements of radiation protection.