Country | Health authority | Availability of the ADC Guidance | ADC CMC Regulated as a biologic? | Source |
United States | FDA | No | No | Draft guidance available on Clinical Pharmacology Considerations for Antibody-Drug Conjugates. Regulated as combinational products through small molecules and biologics. |
European Union | EMA | No | Yes | Same as FDA guidance regulated as combinational, new substance through complete application and mAb and drug-linker are considered as drug substance intermediates |
Japan | PMDA | No | Yes | JNDA Procedure to be followed for submission. Both small molecule and biological regulations are applied. |
Canada | Health Canada | No | Yes | No added Perceptions |
Brazil | ANVISA | No | Yes | No added perceptions |
China | NMPA | Yes, in Draft | Yes | Draft CMC for clinical and nonclinical drafts available |
Korea | MFDS | No | Yes | Both small and large molecules are applicable. High-level requirements for ADC CMC Information |