Timeline and Requirements for Pre-NOC with ARO
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Health Canada is currently reviewing a sponsor's Supplemental New Drug Submission
(SNDS) under Priority Review, to add an additional indication to an already-approved drug. This meets the requirements for both the ARO-2 and the pre-NOC APS submission processes, yet I can't find confirmation in the literature that the two processes are compatible. The intention is to follow the requirements/limitations imposed by both processes. As they both require a letter from the sponsor to attest to the circumstances, would a single consolidated letter from the sponsor be acceptable? Also, as both processes have their own exceptional timelines, would the shorter timeline (ARO-2) supersede the longer (pre-NOC)? -
Health Canada is currently reviewing a sponsor's Supplemental New Drug Submission
(SNDS) under Priority Review, to add an additional indication to an already-approved drug. This meets the requirements for both the ARO-2 and the pre-NOC APS submission processes, yet I can't find confirmation in the literature that the two processes are compatible. The intention is to follow the requirements/limitations imposed by both processes. As they both require a letter from the sponsor to attest to the circumstances, would a single consolidated letter from the sponsor be acceptable? Also, as both processes have their own exceptional timelines, would the shorter timeline (ARO-2) supersede the longer (pre-NOC)?Hello @taylor-murphy
The pre-NOC timelines would supersede the Priority Review pathway as the product is not yet approved for use and therefore cannot take precedence over approved products. Once the product has received NOC, an ARO2 review can be requested if it meets the qualifying criteria. A letter confirming this would be required. Note that as the pre-NOC review could get copy to a “no further comment” stage pending the final TMA, direct pick-up copy would likely qualify for the ARO2 review route.
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Hello @taylor-murphy
The pre-NOC timelines would supersede the Priority Review pathway as the product is not yet approved for use and therefore cannot take precedence over approved products. Once the product has received NOC, an ARO2 review can be requested if it meets the qualifying criteria. A letter confirming this would be required. Note that as the pre-NOC review could get copy to a “no further comment” stage pending the final TMA, direct pick-up copy would likely qualify for the ARO2 review route.
Hello @jennifer-carroll
Thank you for the added clarity. There is no mention of ARO2 being inapplicable to pre-NOC submissions; the PAAB submission form indeed allows the possibility of selecting both options together.
As this concerns an additional indication for an available existing drug, and the APS is a drug access and reimbursement form, we believe it would be in patients' best interest to have this APS available on the day that Health Canada completes the Supplemental Priority Review. Is there anything that can be done to accommodate the time-sensitive nature of patient access to therapy?
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Hello @jennifer-carroll
Thank you for the added clarity. There is no mention of ARO2 being inapplicable to pre-NOC submissions; the PAAB submission form indeed allows the possibility of selecting both options together.
As this concerns an additional indication for an available existing drug, and the APS is a drug access and reimbursement form, we believe it would be in patients' best interest to have this APS available on the day that Health Canada completes the Supplemental Priority Review. Is there anything that can be done to accommodate the time-sensitive nature of patient access to therapy?Good Morning @taylor-murphy
The submissions guidance does not look to outline all inapplicable scenarios. Pre-NOC reviews are a type of submission (see Chapter 5 of the Guidance on Submission Process and Format Requirements) and they are not listed under the submission types available for ARO in the detailer document. Please also note that Chapter 5 states “The PAAB mandate is to review advertising and promotional systems (APS) for approved pharmaceutical products. However, PAAB recognizes the importance of product launch timelines.” The section then goes on to explain the pre-NOC procedures. If you would like the drug access form to be considered one of your two core pre-NOC pieces, this can be considered.
Our PAAB Pre-NOC policy allows 2 files to be submitted prior to NOC. The company has the option to expedite their most important communications once NOC is granted. The pre-NOC reviews are done based on the draft PM. Approval requires the final Health Canada approved terms of market authorization. Please see additional guidance on our policy here.
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Good Morning @taylor-murphy
The submissions guidance does not look to outline all inapplicable scenarios. Pre-NOC reviews are a type of submission (see Chapter 5 of the Guidance on Submission Process and Format Requirements) and they are not listed under the submission types available for ARO in the detailer document. Please also note that Chapter 5 states “The PAAB mandate is to review advertising and promotional systems (APS) for approved pharmaceutical products. However, PAAB recognizes the importance of product launch timelines.” The section then goes on to explain the pre-NOC procedures. If you would like the drug access form to be considered one of your two core pre-NOC pieces, this can be considered.
Our PAAB Pre-NOC policy allows 2 files to be submitted prior to NOC. The company has the option to expedite their most important communications once NOC is granted. The pre-NOC reviews are done based on the draft PM. Approval requires the final Health Canada approved terms of market authorization. Please see additional guidance on our policy here.
Hello @jennifer-carroll
We combed the resources to understand the difference between types of submissions and types of APS. Section 3 of the ARO detailer document lists time-sensitive APS and launch APS for products in Health Canada's Priority Review as acceptable types of APS for ARO. The eFiles submission form itself offers the possibility of filing both ARO and pre-NOC concurrently.
Patient survival rates showed such a marked improvement that Health Canada deemed it necessary to add the indication under Priority Review. Without timely approval of these materials, which we had expected to accomplish using ARO-2 pre-NOC, patients will not have timely access to compassionate treatment. Is there any way to have a lower level ARO applied to a standard pre-NOC submission? -
Hello @jennifer-carroll
We combed the resources to understand the difference between types of submissions and types of APS. Section 3 of the ARO detailer document lists time-sensitive APS and launch APS for products in Health Canada's Priority Review as acceptable types of APS for ARO. The eFiles submission form itself offers the possibility of filing both ARO and pre-NOC concurrently.
Patient survival rates showed such a marked improvement that Health Canada deemed it necessary to add the indication under Priority Review. Without timely approval of these materials, which we had expected to accomplish using ARO-2 pre-NOC, patients will not have timely access to compassionate treatment. Is there any way to have a lower level ARO applied to a standard pre-NOC submission?Hey @taylor-murphy
Please note that the guidance you are referring to states “Launch materials for products approved via Health Canada’s “Interim Order” or their “Accelerated/Priority Review” not “in priority review”. The submission guidance is for approved products. This means Health Canada has granted market authorization with a finalized TMA. Pre-NOC is based on a draft document. The eFile system does not programmatically screen the APS types. This is why the form lists the APS types that are applicable to ARO (i.e., to minimize delays that occur when our admin team needs to return submissions for adjustments).
Furthermore, please note that the first sentence of the previously referenced document clearly outlines PAABs mandate: “The PAAB mandate is to review advertising and promotional systems (APS) for approved pharmaceutical products.”. It also goes on to state “However, PAAB recognizes the importance of product launch timelines, and in this guideline, clarifies procedures for advertising review before Notice of Compliance (NOC) has been granted.” and “PAAB will accommodate pre-NOC submissions at the discretion of the PAAB Commissioner with respect to workload at the time of submission, and will not be subject to the standard turnaround time”.
The pre-NOC policy and the ARO pilot are both manifestations of our commitment to ensuring HCPs and patients receive timely information about therapies. It is important to avoid expediting reviews for materials that cannot be used in the marketplace (as the product is unapproved) at the cost of delaying the review of materials that could be immediately used in the marketplace.
