Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Hello,

Can someone please provide some information on what are the requirements for filing amendment to source clinical trail drug from outside of US.
This after IND Approval. 
Is there a regulation/guidance document which specifies all the documentation requirements that has to go for filing CMC Amendment to IND?

Any thoughts would be much appreciated.

This message was posted by a user wishing to remain anonymous

Equivalence of used IND drug in terms of CMC to the newly sourced material. This is just a general guidance!
You didn't say whether it is API or the whole drug product?
Original Message:
Sent: 09-Apr-2021 12:13
From: Anonymous Member
Subject: Sourcing Drugs for Clinical Trails

This message was posted by a user wishing to remain anonymous

Hello,

Can someone please provide some information on what are the requirements for filing amendment to source clinical trail drug from outside of US.
This after IND Approval.
Is there a regulation/guidance document which specifies all the documentation requirements that has to go for filing CMC Amendment to IND?

Any thoughts would be much appreciated.

This message was posted by a user wishing to remain anonymous

Whole drug Product
Original Message:
Sent: 09-Apr-2021 22:12
From: Anonymous Member
Subject: Sourcing Drugs for Clinical Trails

This message was posted by a user wishing to remain anonymous

Equivalence of used IND drug in terms of CMC to the newly sourced material. This is just a general guidance!
You didn't say whether it is API or the whole drug product?
Original Message:
Sent: 09-Apr-2021 12:13
From: Anonymous Member
Subject: Sourcing Drugs for Clinical Trails

This message was posted by a user wishing to remain anonymous

Hello,

Can someone please provide some information on what are the requirements for filing amendment to source clinical trail drug from outside of US.
This after IND Approval.
Is there a regulation/guidance document which specifies all the documentation requirements that has to go for filing CMC Amendment to IND?

Any thoughts would be much appreciated.

This message was posted by a user wishing to remain anonymous

Hi there,

A lot depends on whether this drug is the actual investigational drug itself or another approved comparator or ancillary agent. If it is an investigational drug, CMC amendment providing appropriate manufacture, release, packing information should be submitted. If it is an approved comparator, an investigational label may be applied but possibly no CMC information needs to be submitted to the IND. You can however submit the certificate of analysis/compliance if provided to you by the manufacturer. You may also refer in the cover letter that the comparator is sourced from country and manufacture name. 

Hope this helps!
Original Message:
Sent: 09-Apr-2021 12:13
From: Anonymous Member
Subject: Sourcing Drugs for Clinical Trails

This message was posted by a user wishing to remain anonymous

Hello,

Can someone please provide some information on what are the requirements for filing amendment to source clinical trail drug from outside of US.
This after IND Approval.
Is there a regulation/guidance document which specifies all the documentation requirements that has to go for filing CMC Amendment to IND?

Any thoughts would be much appreciated.

This message was posted by a user wishing to remain anonymous

Thank you so much. This really helps. Appreciate your response and clarification.

Original Message:
Sent: 11-Apr-2021 19:50
From: Anonymous Member
Subject: Sourcing Drugs for Clinical Trails

This message was posted by a user wishing to remain anonymous

Hi there,

A lot depends on whether this drug is the actual investigational drug itself or another approved comparator or ancillary agent. If it is an investigational drug, CMC amendment providing appropriate manufacture, release, packing information should be submitted. If it is an approved comparator, an investigational label may be applied but possibly no CMC information needs to be submitted to the IND. You can however submit the certificate of analysis/compliance if provided to you by the manufacturer. You may also refer in the cover letter that the comparator is sourced from country and manufacture name.

Hope this helps!
Original Message:
Sent: 09-Apr-2021 12:13
From: Anonymous Member
Subject: Sourcing Drugs for Clinical Trails

This message was posted by a user wishing to remain anonymous

Hello,

Can someone please provide some information on what are the requirements for filing amendment to source clinical trail drug from outside of US.
This after IND Approval.
Is there a regulation/guidance document which specifies all the documentation requirements that has to go for filing CMC Amendment to IND?

Any thoughts would be much appreciated.

You say your IND is approved (i.e. Active) so I assume you included a complete Module 3 section in your IND for the drug substance and drug product. I also assume you are asking about a change in the drug product manufacturing site from US to ex-US but the there are no changes to the drug product - just to the manufacturing site. You'll need to submit a CMC Amendment to add the new site and update any other Mod 3 sections that are impacted by the move to the new site (specs, methods, etc). You'll want to submit stability data generated at the new site. You don't mention what Phase of development you are in, but suggest you refer to FDA's Guidance: INDs for Phase 2 and Phase 3 Studies: 
Chemistry, Manufacturing, and Controls Information. I'm not sure what additional requirements there are for importing the drug product into the US, but I think you'll need to include the IND # on the containers and make it clear that the drug is for Investigational Use Only.​

------------------------------
Tom Stothoff
Senior Director, Regulatory Affairs CMC
Chicago
------------------------------

Original Message:
Sent: 09-Apr-2021 12:13
From: Anonymous Member
Subject: Sourcing Drugs for Clinical Trails

This message was posted by a user wishing to remain anonymous

Hello,

Can someone please provide some information on what are the requirements for filing amendment to source clinical trail drug from outside of US.
This after IND Approval.
Is there a regulation/guidance document which specifies all the documentation requirements that has to go for filing CMC Amendment to IND?

Any thoughts would be much appreciated.

This message was posted by a user wishing to remain anonymous

Tom:

"to source clinical trail drug from outside of US"..........doesn't imply change of manufacturing site!

Hi Anon, please clarify! My response above (first anon response) assumes that you are planning to source from another vendor/supplier and not same supplier with change in manufacturing site.
Original Message:
Sent: 12-Apr-2021 13:15
From: Tom Stothoff
Subject: Sourcing Drugs for Clinical Trails

You say your IND is approved (i.e. Active) so I assume you included a complete Module 3 section in your IND for the drug substance and drug product. I also assume you are asking about a change in the drug product manufacturing site from US to ex-US but the there are no changes to the drug product - just to the manufacturing site. You'll need to submit a CMC Amendment to add the new site and update any other Mod 3 sections that are impacted by the move to the new site (specs, methods, etc). You'll want to submit stability data generated at the new site. You don't mention what Phase of development you are in, but suggest you refer to FDA's Guidance: INDs for Phase 2 and Phase 3 Studies: 
Chemistry, Manufacturing, and Controls Information. I'm not sure what additional requirements there are for importing the drug product into the US, but I think you'll need to include the IND # on the containers and make it clear that the drug is for Investigational Use Only.​

------------------------------
Tom Stothoff
Senior Director, Regulatory Affairs CMC
Chicago

Original Message:
Sent: 09-Apr-2021 12:13
From: Anonymous Member
Subject: Sourcing Drugs for Clinical Trails

This message was posted by a user wishing to remain anonymous

Hello,

Can someone please provide some information on what are the requirements for filing amendment to source clinical trail drug from outside of US.
This after IND Approval.
Is there a regulation/guidance document which specifies all the documentation requirements that has to go for filing CMC Amendment to IND?

Any thoughts would be much appreciated.

This message was posted by a user wishing to remain anonymous

Hello,

Appreciate your response. And to clarify, we are planning to source investigational drug from outside of US from another vendor/supplier.

Original Message:
Sent: 12-Apr-2021 13:42
From: Anonymous Member
Subject: Sourcing Drugs for Clinical Trails

This message was posted by a user wishing to remain anonymous

Tom:

"to source clinical trail drug from outside of US"..........doesn't imply change of manufacturing site!

Hi Anon, please clarify! My response above (first anon response) assumes that you are planning to source from another vendor/supplier and not same supplier with change in manufacturing site.
Original Message:
Sent: 12-Apr-2021 13:15
From: Tom Stothoff
Subject: Sourcing Drugs for Clinical Trails

You say your IND is approved (i.e. Active) so I assume you included a complete Module 3 section in your IND for the drug substance and drug product. I also assume you are asking about a change in the drug product manufacturing site from US to ex-US but the there are no changes to the drug product - just to the manufacturing site. You'll need to submit a CMC Amendment to add the new site and update any other Mod 3 sections that are impacted by the move to the new site (specs, methods, etc). You'll want to submit stability data generated at the new site. You don't mention what Phase of development you are in, but suggest you refer to FDA's Guidance: INDs for Phase 2 and Phase 3 Studies: 
Chemistry, Manufacturing, and Controls Information. I'm not sure what additional requirements there are for importing the drug product into the US, but I think you'll need to include the IND # on the containers and make it clear that the drug is for Investigational Use Only.​

------------------------------
Tom Stothoff
Senior Director, Regulatory Affairs CMC
Chicago

Original Message:
Sent: 09-Apr-2021 12:13
From: Anonymous Member
Subject: Sourcing Drugs for Clinical Trails

This message was posted by a user wishing to remain anonymous

Hello,

Can someone please provide some information on what are the requirements for filing amendment to source clinical trail drug from outside of US.
This after IND Approval.
Is there a regulation/guidance document which specifies all the documentation requirements that has to go for filing CMC Amendment to IND?

Any thoughts would be much appreciated.