Draft guidance on management of rolling reviews for drug submissions: Filing a submission

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Filing and content of the submission

The filing date is established according to the following:

Data or information provided after the submission is filed in accordance with the notice of rolling review status will not change the filing date of the submission.

For a submission that is granted rolling review status, the sponsor must provide a new drug submission (NDS) or supplement to a new drug submission (SNDS) for which the rolling review status was granted within 60 calendar days after the day that Health Canada provides the notice to the sponsor.

Failure to do so within this 60-day period will make the submission ineligible for a rolling review. In this case, the sponsor would have to provide a submission with all information required to assess the safety, efficacy and quality at the time the submission is filed.

To meet C.08.002(4)(c) or C.08.003(5)(c), the drug submission must contain:

At the time it is filed, the submission must contain a significant amount of information to establish the safety and efficacy of the proposed new drug. This is the information that the sponsor indicated it had in its possession to form the basis of the eligibility assessment. Please refer to C.08.002(4)(a)(iii), (iv) and (c).

Health Canada expects the sponsor to provide the following when they file their submission:

Format and structure for filing

For general procedures on how to file drug submissions, please also refer to the following guidance documents:

Screening for rolling review

The drug submission is screened:

Once the screening requirements are met, the sponsor is issued a screening acceptance letter (SAL) and the review 1 period begins. However, the submission will be placed in “rolling review” on the first day of the review 1 period until all missing information is provided in accordance with the notice. Please refer to Performance targets and performance standards.

Providing missing information

As specified in the regulations, sponsors must provide all missing information in accordance with the notice of rolling review status. When providing the balance of the remaining missing information, the sponsor should confirm that it considers all missing information to have been provided.

Failure to adhere to the time and manner for providing the missing information, as specified in the notice, may result in the cancellation of the submission.

Risk management plan

As specified in C.08.002(4), the sponsor may provide the risk management plan (RMP) required under section C.08.002(2) of the regulations to Health Canada after the submission has been filed, as per the notice of rolling review status. The sponsor should submit the RMP either before or when they submit the final version of the clinical study report (CSR) for the pivotal or supportive clinical study or clinical evidence.

For details on the format of RMPs accepted by Health Canada, please refer to the following guidance document:

Also refer to the section on missing information that can “roll”.

Note: The provisions related to RMPs do not apply to veterinary drugs.

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