Notice to stakeholders on the draft pause the clock proposal for pre-market submissions and applications

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Health Canada is pleased to announce the release of the What Was Heard report resulting from the consultation on the draft Pause the Clock Proposal for Pre-market Submissions/Applications. All comments from the 60-day comment period ending October 9, 2018 were reviewed and considered in the finalization of the pause the clock policy.

The following key changes are being made to the pause the clock policy as a result of internal and external stakeholder consultations:

Drugs:

• The principle of not pausing the clock within the last 15% of the performance standard will be removed to increase flexibility for the sponsor.
• The use of expert advisory committees/panels during the review process has been extremely rare; therefore, this does not routinely add time to review. This trigger will be amended to clarify that Health Canada will identify the need for an expert advisory committee/panel as early in the review as possible.
• Clarification will be provided that a small subset of veterinary drugs, namely Veterinary Health Products (VHPs) that are subject to a notification process, are out of scope.
• To ensure openness and transparency on the use of a pause, sponsors will be notified when there is a pause in the review and the overall use of pause the clock will be integrated into existing reporting mechanisms, as applicable.
• A pause will only occur on extensions that go beyond the standard clarification response times as outlined in the most up to date version of the Management of Drug Submissions guidance document for human drugs and the Management of Regulatory Submissions guidance document for veterinary drugs.

Some respondents requested Health Canada to grant short-term extensions without a pause. For the review clock to pause, the request for an extension to respond to a clarification or minor information request will need to be a minimum of 5 days but not beyond 90 days per clarification request. Any extension beyond 5 days without a pause defeats the purpose of the pause the clock proposal whereby Health Canada is only accountable for the time it spends on a particular submission/application.

Medical Devices:

• No changes are being made to the triggers that would pause the clock for medical device applications. Health Canada continues to seek process improvements to Combination Product evaluation.

Some respondents suggested additional triggers that would pause the clock; many of which would fall under the proposed triggers. Implementation of the pause the clock policy will be monitored and the need to modify or add triggers will be assessed over time.

Further, many comments referred to the efficiency and predictability of the review process and changes to penalty provisions. Health Canada is committed to continuing to meet performance standards. Pause the clock is only one tool that is being implemented, along with ongoing measures to improve the efficiency of the submission/application review process.

Introduction of the pause the clock policy is not anticipated to negatively impact aligned reviews, joint reviews, and simultaneous global filings, especially when communicated to collaborating parties.

Comments regarding the acceptance of additional data in a submission once filed were also noted. Although out of scope of this project, this may be looked at under other ongoing/future initiatives.

Several respondents raised questions around the operationalization of the process. The updated policy and additional detail on how it will be operationalized will be communicated in guidance documents that are used by Health Canada and sponsors to navigate the submission/application process, namely:

• Guidance Document: Management of Drug Submissions (for human drugs)
• Guidance For Industry: Management of Regulatory Submissions (for veterinary drugs)
• Management of Applications for Medical Device Licences and Investigational Testing Authorizations

Updated guidance will be publicly available as Health Canada’s renewed cost recovery framework for drugs and medical devices is implemented.

Contact Information

Office of Policy and International Collaboration
Biologics and Genetic Therapies Directorate
Health Products and Food Branch
Health Canada
Building #6, 100 Eglantine Driveway
Tunney’s Pasture
Ottawa, ON K1A 0K9
Address Locator: 0601B
Fax number: (613) 952-5364
hc.bgtd.opic-bpci.dpbtg.sc@canada.ca