Pause-the-Clock Proposal for Drug and Medical Device Establishment Licence Applications

What is pause-the-clock?

Pause-the-clock (commonly referred to as "stop-the-clock") is a new mechanism that allows for the application clock to be formally paused, under specified circumstances to more accurately reflect the time taken by Health Canada to review and render a decision on an application. Pause-the-clock is being proposed as part of the implementation of Health Canada's renewed cost-recovery framework for drugs and medical devices. Under the new framework, the penalty model is intended to ensure each application is completed within the performance standard. All individual applications subject to a fee that are not completed within the established performance of 250 days of Health Canada clock for Drug Establishment Licences (DEL) and 120 days of Health Canada clock for Medical Device Establishment Licences (MDEL) of the Health Canada clock will be rebated 25% of the fee. The purpose of the pause-the-clock is to allow applicants the opportunity to address application deficiencies during the review of the application, without impacting Health Canada review timelines.

Scope and application

The pause-the-clock mechanism will apply to all Establishment Licence applications for drugs and medical devices. This includes applications that are subject to user fees, as well as those that are not.

The pause-the-clock policy does not apply to:

• Applications that include a foreign on-site inspection by Health Canada.
• Processes that are not related to an application (e.g. regular domestic inspections).

The Health Products and Food Branch (HPFB) is developing a separate pause-the-clock proposal specific to pre-market submissions/applications

Proposed model

The purpose of this consultation is to solicit feedback from industry on the proposed model. The following key principles will guide the implementation of a pause-the-clock mechanism:

• The application clock is started when Health Canada receives an Establishment Licence application.
• The clock is paused during the review process only when pre-specified triggers are met (see below for further information on the triggers).
• The application clock is paused for up to 20 business days (1 month) at a time, after which time the application will be deemed incomplete and will be rejected. The 20 business day period is reset each time the clock is paused.
• When a deficiency notice is issued and the response is inadequate, the application will be rejected.
• The policy regarding applicant's requests to delay an inspection does not change. Health Canada expects applicants to be ready for an on-site inspection at the time of submitting their application. However, should Health Canada agree to delay an on-site inspection upon the applicant's request, the clock will be paused from the day the applicant makes the request to delay the inspection until the day the on-site inspection begins.
• The clock is stopped and the total clock time is calculated when a licensing decision has been issued to the applicant.

Proposed triggers that would pause the clock

The proposed pause-the-clock model consists of pausing the application clock during the review process based on specific triggers.

• Deficiency notice issued

In cases where the application requirements listed in the Food and Drugs Regulations (FDR) or Medical Device Regulations (MDR) are not met, a deficiency notice is issued to the applicant. A deficiency would be when an application cannot be further processed by Health Canada because it does not meet regulatory requirements or the intent/scope of the application is not clear. While the clock is paused, the applicant is provided an opportunity to submit the missing or incomplete information in order to avoid receiving a negative decision.

In those circumstances the application clock would be paused for up to 20 business days (1 month) at a time, after which time the application will be deemed incomplete and will be rejected. The 20 business day period is reset each time the clock is paused. Also, when the response to the deficiency notice is inadequate, the application will be rejected.

Examples of deficiencies include but are not limited to:

1. the application does not include Good Manufacturing Practices (GMP) evidence that meets the requirements in GUI-0080 [How to demonstrate foreign building compliance with drug good manufacturing practices]
2. the required Active Pharmaceutical Ingredient (API) information is not included in the application
3. the information in the application is unclear and requires clarification to proceed with the review
4. the Corrective and Preventative Action (CAPA) plan submitted by the company is deficient
5. the evidence is provided but is not as per GUI-0016

• Delayed inspection

Health Canada accepts an applicant's request to delay an on-site inspection.

• Meeting request

Health Canada accepts an applicant's request to meet with the applicant.

• Opportunity to be heard (OTBH)

Health Canada proposes to render a negative decision for an application and issues a notice to the applicant to provide them with an OTBH regarding the proposed decision.

• Late payment of fees

When the invoice for a fee has not been paid within the 30 calendar days, Health Canada will pause the clock in accordance with the withholding service provision of Part II -Administration and Enforcement under the Food and Drugs Act.

Benefits of pause-the-clock

• Pausing the clock can avoid the application receiving a negative decision or Health Canada processing an application that does not represent what the applicant wants or needs (i.e. request for additional information instead of rejecting the application for failure to meet application requirements).
• A pause-the-clock will not delay Health Canada reviews. Health Canada is now fully accountable and responsible for the time it spends reviewing and processing applications. With increased oversight of its time, Health Canada aims to meet and improve its performance standards.
• This initiative will enable Health Canada to report on performance in a more precise manner by providing data on the time an application is under review by Health Canada and by the applicant, providing an accurate representation of the overall application review time for both cost recovered and non-cost recovered applications.
• Health Canada will have the necessary data to revise/improve its performance standards to accurately reflect its review time. Analysis of these data will increase the overall predictability of the application review process.

Consultation questions

Interested and affected stakeholders are asked to provide their feedback on this proposal within 30 days from the date of publication. Health Canada is interested in stakeholder feedback on the following questions:

1. What are your thoughts on the proposed triggers listed? Please provide specific feedback on the proposed triggers.
2. Can you think of a situation in the application process beyond those mentioned within our proposal where a trigger could be used?
3. When would it be valuable from industry's point of view to be able to pause the clock? Please describe under what circumstances this would occur.
4. Is the proposed maximum 20 business day (1 month) of paused clock before rejecting an application reasonable? Would you suggest a shorter or longer timeframe? Please describe situations where more or less time would be more appropriate.

Next steps

All comments will be considered in finalizing the parameters for using the pause-the-clock mechanism.

Health Product Compliance Directorate proposes to hold a multi-stakeholder call with DEL holder associations to discuss feedback received during the consultation period of pause-the-clock.

Medical Device Clinical Compliance Directorate proposes to hold a multi-stakeholder call with MDEL holder associations to discuss feedback received during the consultation period of pause-the-clock.

The pause-the-clock policy will be applicable to the Medical Device and the Drug Establishment Licensing process and will be implemented in parallel with the new user fees for drugs and medical devices, by April 2019. Once implemented, Health Canada will report on the use of the pause-the-clock mechanism to share information on its frequency of use and benefits to the management of the application process.

Health Canada has committed to the following:

• Reporting on performance for Cost Recoverable and Non-Cost Recoverable applications
• Reporting on Health Canada review time, the applicant review time and the total review time
• Prioritizing those applications with the longest pending Health Canada time
• Assessing timelines to determine whether Health Canada can improve performance standards (e.g. shorten time required to process applications)

The following guidance documents that are used by Health Canada and applicants for the DEL application process may be revised to reflect the pause-the-clock mechanism:

• GUI-0080: How to demonstrate foreign building compliance with drug good manufacturing practices
• POL-0011 : GMP Inspection Policy for Canadian Drug Establishments
• GUI-0002 : Guidance on Drug Establishment Licences and Associated Fees
• GUI-0016 : Guidance on Medical Device Establishment Licensing and Medical Device Establishment Licence Fees
• NEW: Management of Applications and Performance Policy for Drug Establishment Licences