WHO published a 31-page draft guideline, "GMP for investigational radiopharmaceutical products", in March 2021. It offers recommendations for minimum standards in the manufacture of new radiopharmaceuticals for Phase I-III clinical trials that do not have a marketing authorization (MAA).
So far, there are no specific GMP requirements by the WHO for these phases of testing. The WHO and the IAEA (International Atomic Energy Agency) therefore saw the need to close this gap.
What are the reasons given by WHO/IAEA for this?
- Molecular imaging agents and new therapies using targeted radioligands offer new methods for detecting diseases and their extent, as well as therapeutic alternatives for patients for whom no other options are available.
- Inadequate manufacturing controls in early clinical evaluations risk the unnecessary harm to patients and the validity of studies. Redundant controls, on the other hand, slow down the development process of potentially life-saving therapies and come at a high cost.
- Some countries lack high-level GMP requirements and knowledge of contamination risks and cross-contamination and toxicity.
The new document is intended to meet current expectations and trends in GMP for radiopharmaceutical investigational products for clinical trials. Harmonization with other international guidelines is included as well.
The recommendations are not applicable to phase IV radiopharmaceuticals already approved for a specific indication, but may be used in clinical trials for another indication.
The document should be read in conjunction with other WHO/IAEA guidelines such as:
- World Health Organization (WHO) GMP guidelines
- including good clinical practice (GCP)
- good documentation practices
- International Atomic Energy Agency (IAEA) radiation protection documents related to radiopharmaceuticals.
The guideline is expected to be available in a final version as early as October 2021.
WHO: International Atomic Energy Agency (IAEA)/World Health Organization (WHO) guideline on good manufacturing practices for investigational radiopharmaceutical products