Reply To: IND "in-effect" US Importation – Benchmark

[Anonymous]

Reply To: IND "in-effect" US Importation – Benchmark

For NEW INDs we have imported on the 30th day and include a copy of the IND Acknowledgement letter with the entry to ensure the port could see the IND had reached the effective time period. This was reviewed with our company wide compliance and legal group in 2016 when ACE was rolled out.

Guiding principles are:
– 21CFR312 regulates the importation of drugs under the IND
– 312.110 indicates that the IND must be in effect (as noted in 312.40).
– 312.40 indicates that an IND is effective 30 days after the filing
– May not import if the FDA places IND on a clinical hold
– May import sooner than 30 days if the FDA issues an authorization that the study may commence.