On November 22, 2025, Swissmedic officially granted the first authorization of 18F-PSMA-1007 ZRP®. This approval represents an important milestone in nuclear medicine and diagnostic imaging. Clinical, quality, and regulatory professionals are advised to evaluate its implications and opportunities in line with regulatory compliance requirements.
What changed?
Swissmedic has verified and approved the 18F-PSMA-1007 ZRP®, marking its initial authorization for use. This radiopharmaceutical is designed to enhance diagnostic capabilities in prostate cancer by targeting prostate-specific membrane antigen (PSMA), which is overexpressed in malignant tissues. The approval aligns with Swissmedic’s commitment to supporting innovative diagnostic tools backed by safety and performance data.
Who is affected?
Key stakeholders include imaging centers, oncologists specializing in prostate cancer, and nuclear medicine professionals. Regulatory affairs teams managing market introduction for radiopharmaceuticals will also find this authorization highly significant. The device’s availability is expected to catalyze better diagnostic accuracy in cases of suspected prostate cancer recurrence.
Material details of the device
The 18F-PSMA-1007 ZRP® uses fluorine-18 isotope radiolabeling. This approach allows highly specific imaging of PSMA-expressing cells using positron emission tomography (PET). Manufacturing processes and compliance align with strict standards under Swissmedic’s jurisdiction. The authorized use is intended to optimize clinical management by providing high-resolution, precise imaging.
Swissmedic reviewed the submission by the manufacturer and evaluated data on performance and safety generated during clinical trials. The therapeutic margin and radiation exposure levels were found to be within acceptable limits, ensuring patient safety and device efficacy.
Frequently Asked Questions
1. What is the intended use of 18F-PSMA-1007 ZRP®?
The radiopharmaceutical is intended for PET imaging in patients with prostate cancer. It targets PSMA to provide clear diagnostic imaging for recurrence assessment.
2. What safety measures are in place?
All manufacturing processes adhere to regulatory standards for radiopharmaceuticals. Radiation doses have been reviewed and deemed appropriate for clinical application.
3. Are there restrictions on this device’s use?
Authorization is specific to diagnostic imaging applications for prostate cancer. Training and compliance with nuclear medicine regulations are required for healthcare providers.
Recap
Swissmedic’s authorization of 18F-PSMA-1007 ZRP® establishes the product as a viable diagnostic tool in prostate cancer imaging. Stakeholders are encouraged to stay informed of compliance and integration strategies to leverage this new technology.
Disclaimer
This announcement is intended for professionals in regulatory, clinical, and quality fields. It provides general information on Swissmedic’s authorization and is not legal or regulatory advice.