Regulatory Open Forum

Hello,

Appreciate input if you have experience importing drug substance manufactured at an additional EU site to a US drug product site?  A DS site (current site) is already filed in the IND module 3; the additional DS site has not yet been filed to the IND.

The regulations (21 CFR 312.110 and 21 CFR 312.40, shown below) allow investigational new drug to be imported into the US under an effective IND.  This drug is under an effective IND and the IND number will be listed in the end use letter.

Is an effective IND sufficient for US importation and customs? 

Thanks in advance 

------------

https://www.ecfr.gov/current/title-21/chapter-I/subchapter-D/part-312/subpart-F/section-312.110

21 CFR 312.110 -- Import and export requirements.

(a) Imports. An investigational new drug offered for import into the United States complies with the requirements of this part if it is subject to an IND that is in effect for it under § 312.40 and:

(1) The consignee in the United States is the sponsor of the IND;

(2) the consignee is a qualified investigator named in the IND; or

(3) the consignee is the domestic agent of a foreign sponsor, is responsible for the control and distribution of the investigational drug, and the IND identifies the consignee and describes what, if any, actions the consignee will take with respect to the investigational drug.

312.40 General requirements for use of an investigational new drug in a clinical investigation.

(a) An investigational new drug may be used in a clinical investigation if the following conditions are met:

(1) The sponsor of the investigation submits an IND for the drug to FDA; the IND is in effect under paragraph (b) of this section; and the sponsor complies with all applicable requirements in this part and parts 50 and 56 with respect to the conduct of the clinical investigations; and

(2) Each participating investigator conducts his or her investigation in compliance with the requirements of this part and parts 50 and 56.

(b) An IND goes into effect:

(1) Thirty days after FDA receives the IND, unless FDA notifies the sponsor that the investigations described in the IND are subject to a clinical hold under § 312.42; or

(2) On earlier notification by FDA that the clinical investigations in the IND may begin. FDA will notify the sponsor in writing of the date it receives the IND.

(c) A sponsor may ship an investigational new drug to investigators named in the IND:

(1) Thirty days after FDA receives the IND; or

(2) On earlier FDA authorization to ship the drug.

(d) An investigator may not administer an investigational new drug to human subjects until the IND goes into effect under paragraph (b) of this section.

Hello,

Appreciate input if you have experience importing drug substance manufactured at an additional EU site to a US drug product site?  A DS site (current site) is already filed in the IND module 3; the additional DS site has not yet been filed to the IND.

The regulations (21 CFR 312.110 and 21 CFR 312.40, shown below) allow investigational new drug to be imported into the US under an effective IND.  This drug is under an effective IND and the IND number will be listed in the end use letter.

Is an effective IND sufficient for US importation and customs? 

Thanks in advance 

------------

https://www.ecfr.gov/current/title-21/chapter-I/subchapter-D/part-312/subpart-F/section-312.110

21 CFR 312.110 -- Import and export requirements.

(a) Imports. An investigational new drug offered for import into the United States complies with the requirements of this part if it is subject to an IND that is in effect for it under § 312.40 and:

(1) The consignee in the United States is the sponsor of the IND;

(2) the consignee is a qualified investigator named in the IND; or

(3) the consignee is the domestic agent of a foreign sponsor, is responsible for the control and distribution of the investigational drug, and the IND identifies the consignee and describes what, if any, actions the consignee will take with respect to the investigational drug.

312.40 General requirements for use of an investigational new drug in a clinical investigation.

(a) An investigational new drug may be used in a clinical investigation if the following conditions are met:

(1) The sponsor of the investigation submits an IND for the drug to FDA; the IND is in effect under paragraph (b) of this section; and the sponsor complies with all applicable requirements in this part and parts 50 and 56 with respect to the conduct of the clinical investigations; and

(2) Each participating investigator conducts his or her investigation in compliance with the requirements of this part and parts 50 and 56.

(b) An IND goes into effect:

(1) Thirty days after FDA receives the IND, unless FDA notifies the sponsor that the investigations described in the IND are subject to a clinical hold under § 312.42; or

(2) On earlier notification by FDA that the clinical investigations in the IND may begin. FDA will notify the sponsor in writing of the date it receives the IND.

(c) A sponsor may ship an investigational new drug to investigators named in the IND:

(1) Thirty days after FDA receives the IND; or

(2) On earlier FDA authorization to ship the drug.

(d) An investigator may not administer an investigational new drug to human subjects until the IND goes into effect under paragraph (b) of this section.

You'll want to amend your IND to add the new DS site by submitting a complete Module 3 32S section.

Hello,

Appreciate input if you have experience importing drug substance manufactured at an additional EU site to a US drug product site?  A DS site (current site) is already filed in the IND module 3; the additional DS site has not yet been filed to the IND.

The regulations (21 CFR 312.110 and 21 CFR 312.40, shown below) allow investigational new drug to be imported into the US under an effective IND.  This drug is under an effective IND and the IND number will be listed in the end use letter.

Is an effective IND sufficient for US importation and customs? 

Thanks in advance 

------------

https://www.ecfr.gov/current/title-21/chapter-I/subchapter-D/part-312/subpart-F/section-312.110

21 CFR 312.110 -- Import and export requirements.

(a) Imports. An investigational new drug offered for import into the United States complies with the requirements of this part if it is subject to an IND that is in effect for it under § 312.40 and:

(1) The consignee in the United States is the sponsor of the IND;

(2) the consignee is a qualified investigator named in the IND; or

(3) the consignee is the domestic agent of a foreign sponsor, is responsible for the control and distribution of the investigational drug, and the IND identifies the consignee and describes what, if any, actions the consignee will take with respect to the investigational drug.

312.40 General requirements for use of an investigational new drug in a clinical investigation.

(a) An investigational new drug may be used in a clinical investigation if the following conditions are met:

(1) The sponsor of the investigation submits an IND for the drug to FDA; the IND is in effect under paragraph (b) of this section; and the sponsor complies with all applicable requirements in this part and parts 50 and 56 with respect to the conduct of the clinical investigations; and

(2) Each participating investigator conducts his or her investigation in compliance with the requirements of this part and parts 50 and 56.

(b) An IND goes into effect:

(1) Thirty days after FDA receives the IND, unless FDA notifies the sponsor that the investigations described in the IND are subject to a clinical hold under § 312.42; or

(2) On earlier notification by FDA that the clinical investigations in the IND may begin. FDA will notify the sponsor in writing of the date it receives the IND.

(c) A sponsor may ship an investigational new drug to investigators named in the IND:

(1) Thirty days after FDA receives the IND; or

(2) On earlier FDA authorization to ship the drug.

(d) An investigator may not administer an investigational new drug to human subjects until the IND goes into effect under paragraph (b) of this section.

The question pertains to import criteria for a d/s (i.e. from new site) into the US subject of an already effective IND! The Compliance at the airport would only look if the IND number is effective. The amendment to the IND for new site is subject to review division at the center/IND regulations and of course that needs to be filed but not related to the import criteria (i.e. the OP question) check list for FDA compliance at the Airport! 

You'll want to amend your IND to add the new DS site by submitting a complete Module 3 32S section.

Hello,

Appreciate input if you have experience importing drug substance manufactured at an additional EU site to a US drug product site?  A DS site (current site) is already filed in the IND module 3; the additional DS site has not yet been filed to the IND.

The regulations (21 CFR 312.110 and 21 CFR 312.40, shown below) allow investigational new drug to be imported into the US under an effective IND.  This drug is under an effective IND and the IND number will be listed in the end use letter.

Is an effective IND sufficient for US importation and customs? 

Thanks in advance 

------------

https://www.ecfr.gov/current/title-21/chapter-I/subchapter-D/part-312/subpart-F/section-312.110

21 CFR 312.110 -- Import and export requirements.

(a) Imports. An investigational new drug offered for import into the United States complies with the requirements of this part if it is subject to an IND that is in effect for it under § 312.40 and:

(1) The consignee in the United States is the sponsor of the IND;

(2) the consignee is a qualified investigator named in the IND; or

(3) the consignee is the domestic agent of a foreign sponsor, is responsible for the control and distribution of the investigational drug, and the IND identifies the consignee and describes what, if any, actions the consignee will take with respect to the investigational drug.

312.40 General requirements for use of an investigational new drug in a clinical investigation.

(a) An investigational new drug may be used in a clinical investigation if the following conditions are met:

(1) The sponsor of the investigation submits an IND for the drug to FDA; the IND is in effect under paragraph (b) of this section; and the sponsor complies with all applicable requirements in this part and parts 50 and 56 with respect to the conduct of the clinical investigations; and

(2) Each participating investigator conducts his or her investigation in compliance with the requirements of this part and parts 50 and 56.

(b) An IND goes into effect:

(1) Thirty days after FDA receives the IND, unless FDA notifies the sponsor that the investigations described in the IND are subject to a clinical hold under § 312.42; or

(2) On earlier notification by FDA that the clinical investigations in the IND may begin. FDA will notify the sponsor in writing of the date it receives the IND.

(c) A sponsor may ship an investigational new drug to investigators named in the IND:

(1) Thirty days after FDA receives the IND; or

(2) On earlier FDA authorization to ship the drug.

(d) An investigator may not administer an investigational new drug to human subjects until the IND goes into effect under paragraph (b) of this section.