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
Types of RAM licenses
There are 2 primary types of RAM licenses, each designed according to the type of RAM and its corresponding safety programs. The licenses address specific safety, regulatory, and operational concerns, taking into account the complexity and potential risks associated with the activities it governs.1,2
General license
Grants the authority for low-risk activities, typically requiring minimal oversight.1 This type of license is common for small quantities of RAM (in the order of microcuries) used in non-human applications. These licenses are not medical use licenses.2
Specific license
Grants the authority for activities involving higher risk or complex applications, such as RLT. All internal or external administrations of RAM to human patients or human research participants must be done in accordance with a specific license for medical use.2
RLT programs require specific licenses for medical use
Due to the relative complexity, safety protocols, and regulatory oversight needed for use of therapeutic radioactive materials, facilities require specific licenses to administer RLTs like PLUVICTO® (lutetium Lu 177 vipivotide tetraxetan) and LUTATHERA® (lutetium Lu 177 dotatate).1-5
RAM licenses for medical use follow the Nuclear Regulatory Commission (NRC) Regulations Title 10, Code of Federal Regulations, Part 356. RLT programs follow Subpart E. Specifically, the use of unsealed byproduct (ie, RAM) is required.7
Within specific licenses, there are limited scope and broad scope options, determined by the range and extent of RAM authorized for use.2
Limited scope specific license
Intended for facilities with narrowly defined needs for RAM2
- Typically utilized by small private groups or medical institutions2
- Focused and restricted to specific applications2
- Issued for specific, controlled uses of RAM2
- Requires defined uses of specific radionuclides2
Broad scope specific license
Intended for facilities with diverse and flexible needs for RAM2
- Typically utilized by larger medical institutions2
- Allows broader use of RAM across departments and activities3
- Permits unspecified quantities (within cumulative limits) and multiple types of RAM for medical research, diagnosis, and therapy, with oversight by the radiation safety officer (RSO) and an internal radiation safety committee (RSC)8
Expert insight
- Pursuing a broad scope license can benefit facilities by minimizing the need for future amendments as the RLT program grows, offering a measure of freedom in program oversight, but may be more demanding of the RSO than limited scope licenses9
- Contact the local regulatory body and the Novartis radioligand therapy specialists early and often for information about pursuing a RAM license