Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Is a new IMPD required if an additional clinical study utilizes the exact same API, drug product formulation, manufacturers, container closure, etc?  The new study is part of the disease progression.  Dosage and delivery are the same.  There will of course be a new clinical protocol.

This message was posted by a user wishing to remain anonymous

Basically you are saying no changes to the CMC section of the original IND/clinical study and you are planning to use the same API/DP for the second study? Then it's not a new IMPD and thus not required to submit the CMC section, just do cross reference!
Original Message:
Sent: 07-Nov-2021 22:45
From: Anonymous Member
Subject: Is a new IMPD required...

This message was posted by a user wishing to remain anonymous

Is a new IMPD required if an additional clinical study utilizes the exact same API, drug product formulation, manufacturers, container closure, etc?  The new study is part of the disease progression.  Dosage and delivery are the same.  There will of course be a new clinical protocol.

In the EU, each clinical study requires submission of a unique Clinical Trial Application (CTA). As opposed to US where every study protocol is submitted to the same application (IND). I'm not aware whether EU allows you to cross reference the IMPD from one CTA to another.  You may have to re-submit the IMPD with the new CTA.  But to answer your question, you can submit the same IMPD (same version) in the new CTA.

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Tom Stothoff
Senior Director, Regulatory Affairs CMC
Chicago
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Original Message:
Sent: 08-Nov-2021 18:25
From: Anonymous Member
Subject: Is a new IMPD required...

This message was posted by a user wishing to remain anonymous

Basically you are saying no changes to the CMC section of the original IND/clinical study and you are planning to use the same API/DP for the second study? Then it's not a new IMPD and thus not required to submit the CMC section, just do cross reference!
Original Message:
Sent: 07-Nov-2021 22:45
From: Anonymous Member
Subject: Is a new IMPD required...

This message was posted by a user wishing to remain anonymous

Is a new IMPD required if an additional clinical study utilizes the exact same API, drug product formulation, manufacturers, container closure, etc?  The new study is part of the disease progression.  Dosage and delivery are the same.  There will of course be a new clinical protocol.

Hello,

following on Tom's reply, while a new CTA is required for each new study (or expansion of study), a cross-reference (via a so-called "simplified" IMPD) to a previously submitted and approved IMPD is in principle admissible in most countries, and accepted by most health authorities. There are exceptions, however. For instance, Health Canada does not accept cross-reference of a phase 2 CTA to a phase 1 CTA; BfArM and Swissmedic do not typically allow for such cross-references.  Needless to say, a resubmission may trigger another round of review; hence the potential advantage of cross-referencing.

Maurizio Franzini

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Maurizio Franzini
Regulatory Affairs CMC, Associate Director
San Francisco CA
United States
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Original Message:
Sent: 07-Nov-2021 22:45
From: Anonymous Member
Subject: Is a new IMPD required...

This message was posted by a user wishing to remain anonymous

Is a new IMPD required if an additional clinical study utilizes the exact same API, drug product formulation, manufacturers, container closure, etc?  The new study is part of the disease progression.  Dosage and delivery are the same.  There will of course be a new clinical protocol.