New agile regulatory provisions and updated guidance document for submitting risk management plans: Notice

New provisions for risk management plans

The Regulations Amending Certain Regulations Made Under the Food and Drugs Act (Agile Licensing), also known as the Agile Regulations, were published on December 18, 2024, in Canada Gazette, Part II.

The new provisions in the Food and Drug Regulations that relate to risk management plans will come into force on April 1, 2027. The provisions will reinforce Health Canada’s long-standing practices on submitting risk management plans (RMPs) to support a lifecycle approach to the regulation of drugs.

Consultations

The proposed regulations were published in Canada Gazette, Part I (CGI), on December 17, 2022. Stakeholders had 130 days to comment. We also made the draft guidance document available for comment at that time.

During the CGI consultation, we received:

116 comments on the proposed RMP regulatory provisions and policy from 27 stakeholders
273 comments on the proposed RMP guidance document and processes from 18 stakeholders

We also received feedback during bilateral meetings with industry associations.

We considered all comments when finalizing the RMP provisions of the Agile Regulations and updating the guidance document and our internal processes.

Transitioning to the new regulations

We have put in place transitional provisions to help transition RMPs that will have been submitted under our existing policy before the Agile Regulations come into force.

Existing RMPs

An RMP provided before coming into force will be considered an existing RMP if we have already indicated that it was acceptable. Existing RMPs will be subject to the RMP updating provisions once they come into force.

An indication that the RMP was acceptable could include the following scenarios:

We provided a written notice to the manufacturer indicating that the RMP was either acceptable or acceptable with revisions or recommendations, such as in:
- a letter addressed to the manufacturer following the review of the RMP
- a post-decision letter
We issued a notice of compliance (NOC) for a drug submission, which included an RMP in the submission package, and did not provide written notice to the manufacturer indicating that the:
- RMP was not acceptable or
- review identified deficiencies with the RMP

A post-market RMP or an RMP update provided before coming into force, and is still being reviewed at the time of coming into force, would be considered an existing RMP once we have indicated to the manufacturer that the RMP is acceptable.

According to section C.08.003.3 of the Food and Drug Regulations, an RMP provided before coming into force with a Division 8 pre-market submission, or supplement to a submission, and for which an issuance decision has not yet been made at the time of coming into force, would be considered an existing RMP once we have issued an authorization.

An RMP provided before coming into force with a Division 1 pre-market application, and for which a DIN has not yet been issued at the time of coming into force, would be considered an existing RMP once we have issued a DIN.

Review of RMPs at coming into force

In accordance with the Agile Regulations, RMPs must meet the requirements set out in section C.01.701 of the Food and Drug Regulations. This will apply to the review of:

any RMP provided before coming into force with a Division 8 pre-market submission or supplement to a submission, for which an issuance decision has not yet been made at the time of coming into force
any RMP provided before coming into force with a Division 1 pre-market submission, for which a DIN has not yet been issued at the time of coming into force

Any post-market RMP or RMP update provided before coming into force is expected to meet our existing RMP policies outlined in guidance.

All RMPs provided on or after April 1, 2027, must meet the requirements set out in section C.01.701 of the Food and Drug Regulations.

Guidance on submitting risk management plans

We will be updating the Submission of Risk Management Plans and Follow-up Commitments Guidance Document to reflect updated policy. We are basing some of these changes on comments we received from stakeholders, including those received during the CGI consultation period.

We are also consolidating our guidance on RMPs by incorporating and updating the content from the following:

Notice of clarification to drug manufacturers and sponsors - Risk management plans (update)
Notice of clarification to drug manufacturers and sponsors: Canadian-specific considerations in risk management plans

Starting on July 1, 2025, and until the RMP provisions come into force under the Agile Regulations on April 1, 2027, the submission and review of RMPs will be subject to the updated guidance document. The updated guidance document will reflect many of the policy elements outlined in the Agile Regulations, as well as feedback received during consultations.

In fall 2026, we will make further changes to the guidance document to fully reflect the RMP provisions in the Food and Drug Regulations. We will also consolidate guidance on RMPs by incorporating and updating the content from the Submission of Targeted Risk Management Plans and Follow-up Commitments for Prescription Opioid-Containing Products: Guidance for Industry.

Although we will not be holding additional formal consultations on these RMP guidance documents, we may consider feedback we receive before April 1, 2026. You may submit your feedback by email to mhpdpolicy-politiquesdpsc@hc-sc.gc.ca.

Contact us

Regulatory Policy Section
Marketed Health Products Directorate
Health Canada
Email: mhpdpolicy-politiquesdpsc@hc-sc.gc.ca

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2024-12-18