Regulatory Open Forum

RAPS email.<o:p></o:p>

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Hello RAPS collective wisdom!<o:p></o:p>

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I have questions about communicating to Health Canada with respect to an Investigator's Brochure (or Canadian Product Monograph, or US Package Insert, used as the "IB"). <o:p></o:p>

The project has an active CTA with Health Canada (HC). The need to communicate with HC has been low – no amendments or other notifications (yet). Per HC CTA guidance about IB updates:<o:p></o:p>

In accordance with ICH GCP, the IB, including all safety information and global status, should be reviewed at least annually and revised as necessary.  More frequent revision may be appropriate depending on the stage of development and the generation of relevant new information.  If the sponsor is planning to submit a CTA, or planning or required to submit a CTA-A or CTA-N, the updated IB should be submitted with the application.  Otherwise, the updated IB should be submitted separately as a CTA-N, and include a statement confirming that the protocol and/or ICF of all ongoing trials do not require changes as a result of the updated IB.  In all cases, the updated IB should be accompanied by a list of changes that clearly describes the sections that have changed, including a rationale for each change.<o:p></o:p>

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All this is fine, but I note that within this text there is no guidance on what to do if there are "no changes" to the IB and we have no other communications planned. Does one send a "stand alone" Notification (email) to HC stating "no change"? Why?<o:p></o:p>

Further, what if we were using an approved, Canadian marketed drug? In this case we would usually use the Canadian Product Monograph as the "IB". And since we are not the drug's manufacturer, we don't control the PM. Do we review HC's drug product database for an updated PM? Yes, we do this. <o:p></o:p>

But again as above, what if there is no change/update? Does one send a "stand alone" Notification (email) to HC stating "no change" in the PM? Why, especially given that HC already knows (has access to) the PM and would know that there is no change?<o:p></o:p>

Finally, same scenario and question as the Canadian Product Monograph, but with a US marketed drug. We import the US drug into Canada for our study (there is no comparable drug version approved in Canada; e.g. pediatric doses approved in USA but not Canada). We are using the US Package Insert as our reference/safety information. We are not the drug's manufacturer, so we don't control the package insert. Yes, we review yearly for an updated package insert. <o:p></o:p>

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Thanks for all your help.<o:p></o:p>

David<o:p></o:p>

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RAPS email.<o:p></o:p>

<o:p> </o:p>

Hello RAPS collective wisdom!<o:p></o:p>

<o:p> </o:p>

I have questions about communicating to Health Canada with respect to an Investigator's Brochure (or Canadian Product Monograph, or US Package Insert, used as the "IB"). <o:p></o:p>

The project has an active CTA with Health Canada (HC). The need to communicate with HC has been low – no amendments or other notifications (yet). Per HC CTA guidance about IB updates:<o:p></o:p>

In accordance with ICH GCP, the IB, including all safety information and global status, should be reviewed at least annually and revised as necessary.  More frequent revision may be appropriate depending on the stage of development and the generation of relevant new information.  If the sponsor is planning to submit a CTA, or planning or required to submit a CTA-A or CTA-N, the updated IB should be submitted with the application.  Otherwise, the updated IB should be submitted separately as a CTA-N, and include a statement confirming that the protocol and/or ICF of all ongoing trials do not require changes as a result of the updated IB.  In all cases, the updated IB should be accompanied by a list of changes that clearly describes the sections that have changed, including a rationale for each change.<o:p></o:p>

<o:p> </o:p>

All this is fine, but I note that within this text there is no guidance on what to do if there are "no changes" to the IB and we have no other communications planned. Does one send a "stand alone" Notification (email) to HC stating "no change"? Why?<o:p></o:p>

Further, what if we were using an approved, Canadian marketed drug? In this case we would usually use the Canadian Product Monograph as the "IB". And since we are not the drug's manufacturer, we don't control the PM. Do we review HC's drug product database for an updated PM? Yes, we do this. <o:p></o:p>

But again as above, what if there is no change/update? Does one send a "stand alone" Notification (email) to HC stating "no change" in the PM? Why, especially given that HC already knows (has access to) the PM and would know that there is no change?<o:p></o:p>

Finally, same scenario and question as the Canadian Product Monograph, but with a US marketed drug. We import the US drug into Canada for our study (there is no comparable drug version approved in Canada; e.g. pediatric doses approved in USA but not Canada). We are using the US Package Insert as our reference/safety information. We are not the drug's manufacturer, so we don't control the package insert. Yes, we review yearly for an updated package insert. <o:p></o:p>

<o:p> </o:p>

Thanks for all your help.<o:p></o:p>

David<o:p></o:p>

<o:p> </o:p>

<o:p> </o:p>

<o:p> </o:p>

<o:p> </o:p>

RAPS email.<o:p></o:p>

<o:p> </o:p>

Hello RAPS collective wisdom!<o:p></o:p>

<o:p> </o:p>

I have questions about communicating to Health Canada with respect to an Investigator's Brochure (or Canadian Product Monograph, or US Package Insert, used as the "IB"). <o:p></o:p>

The project has an active CTA with Health Canada (HC). The need to communicate with HC has been low – no amendments or other notifications (yet). Per HC CTA guidance about IB updates:<o:p></o:p>

In accordance with ICH GCP, the IB, including all safety information and global status, should be reviewed at least annually and revised as necessary.  More frequent revision may be appropriate depending on the stage of development and the generation of relevant new information.  If the sponsor is planning to submit a CTA, or planning or required to submit a CTA-A or CTA-N, the updated IB should be submitted with the application.  Otherwise, the updated IB should be submitted separately as a CTA-N, and include a statement confirming that the protocol and/or ICF of all ongoing trials do not require changes as a result of the updated IB.  In all cases, the updated IB should be accompanied by a list of changes that clearly describes the sections that have changed, including a rationale for each change.<o:p></o:p>

<o:p> </o:p>

All this is fine, but I note that within this text there is no guidance on what to do if there are "no changes" to the IB and we have no other communications planned. Does one send a "stand alone" Notification (email) to HC stating "no change"? Why?<o:p></o:p>

Further, what if we were using an approved, Canadian marketed drug? In this case we would usually use the Canadian Product Monograph as the "IB". And since we are not the drug's manufacturer, we don't control the PM. Do we review HC's drug product database for an updated PM? Yes, we do this. <o:p></o:p>

But again as above, what if there is no change/update? Does one send a "stand alone" Notification (email) to HC stating "no change" in the PM? Why, especially given that HC already knows (has access to) the PM and would know that there is no change?<o:p></o:p>

Finally, same scenario and question as the Canadian Product Monograph, but with a US marketed drug. We import the US drug into Canada for our study (there is no comparable drug version approved in Canada; e.g. pediatric doses approved in USA but not Canada). We are using the US Package Insert as our reference/safety information. We are not the drug's manufacturer, so we don't control the package insert. Yes, we review yearly for an updated package insert. <o:p></o:p>

<o:p> </o:p>

Thanks for all your help.<o:p></o:p>

David<o:p></o:p>

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