Licensing and safety
This section of the Novartis RLT Institute reviews important aspects for obtaining or amending a radioactive materials (RAM) license for medical use, including types of licenses, components of the application, and key individuals, focusing on the key considerations for a radioligand therapy (RLT) program.
RAM licensing
Timelines to approve RAM licenses
The approval timeline depends on several factors, including the complexity of the application, completeness of the submitted documentation, and whether any additional documentation or clarifications are needed.1
The Nuclear Regulatory Commission (NRC) website states that after submitting the NRC Form 313, the initial review can take 90 days, but experiences vary.1 These timelines may also vary by state. The NRC and state regulators may request additional follow-up, which can take additional time. As a result, it is important when starting an RLT facility to be prepared for the RAM license approval to be a rigorous and lengthy process, potentially lasting 6 months or more, and it is therefore important to start the process as soon as practical.2
Therefore, it is recommended to directly contact the NRC, the state regulatory agency, and/or consult their regulatory guides for further details.