Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Dear RA Folks:

My company is planning to initiate a Phase 1 combination oncology drug trial in EU. This drug trial is already active in the US. One of the drug agents is ours (investigational), and the other drug in the combination drug trial is a marketed approved drug. My company has no rights or proprietary partnership with the company that manufactures the approved drug in the combination.

My current plan will be to include the following in the clinical trial application, related to the marketed approved product in the combo:

1. investigational labe, as combo with our investigational agent is unapproved use of course. 
2. Include appropriate safety and monitoring information in the protocol, IB, and ICF. 
3. Make reference to SmPC for the marketed approved product in the combo.
4. Use locally sourced (EMA approved) marketed drug product. 

However, our CRO tells us for EU countries we also need to provide a simplified sIMPD for the marketed approved drug. I have no experience with and sIMPD. I am not sure what information on the marketed drug, given we have no access to proprietary CMC information.

See TOC excerpt from EMA guidance document below.  We are not modifying the marketed drug product (except over-labeling investigational labeling). So wouldn't it be appropriate to simply reference the SmPC in the cover letter?

I would greatly appreciate any insights on this.

I agree that submission of an SmPC for an authorized drug used within the conditions of the SmPC is sufficient. Under those conditions, the SmPC is the simplified IMPD.

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Glen Park PharmD
Vice President, Regulatory Affairs and Quality Assurance
New York NY
United States
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Original Message:
Sent: 29-Aug-2022 13:21
From: Anonymous Member
Subject: Simplified IMPD (sIMPD) for a marketed drug product requirement, for EU drug trials

This message was posted by a user wishing to remain anonymous

Dear RA Folks:

My company is planning to initiate a Phase 1 combination oncology drug trial in EU. This drug trial is already active in the US. One of the drug agents is ours (investigational), and the other drug in the combination drug trial is a marketed approved drug. My company has no rights or proprietary partnership with the company that manufactures the approved drug in the combination.

My current plan will be to include the following in the clinical trial application, related to the marketed approved product in the combo:

1. investigational labe, as combo with our investigational agent is unapproved use of course. 
2. Include appropriate safety and monitoring information in the protocol, IB, and ICF. 
3. Make reference to SmPC for the marketed approved product in the combo.
4. Use locally sourced (EMA approved) marketed drug product. 

However, our CRO tells us for EU countries we also need to provide a simplified sIMPD for the marketed approved drug. I have no experience with and sIMPD. I am not sure what information on the marketed drug, given we have no access to proprietary CMC information.

See TOC excerpt from EMA guidance document below.  We are not modifying the marketed drug product (except over-labeling investigational labeling). So wouldn't it be appropriate to simply reference the SmPC in the cover letter?

I would greatly appreciate any insights on this.