Regulatory Corner

The SRS provides the below links as a resource to members who would like to learn more about clinical regulatory requirements. However, providing these links should not be interpreted as a complete endorsement of stated recommendations and procedures.

ASIA

Japanese Guidelines for PET Clinical Research - in includes:
1. Guideline for production of PET RP (JSNM cGMP for PET Drugs)  
2. Guideline for preclinical tests for PET RP  
3. Guideline for clinical trial for PET RP.
~ Unfortunately, there is no English version of this document.

EUROPE

The European Association of Nuclear Medicine's Radiopharmaceutical Guidelines

UNITED STATES

1. FDA CGMP for PET Rule
2. FDA Guidance document
3. CMC Postapproval Manufacturing Changes To Be Documented
5. FDA Oversight of PET Drug Products - Q&A
6. IND Applications for PET Drugs
7. Sterile Drug Products via Aseptic Processing - CGMP

If you would like to recommend documents and links to add to the Regulatory Corner, please provide your suggestion(s) through the Contact page.