Update on Performance Standards for NHP Applications

Update on Performance Standards for NHP Applications

Summary of Health Canada Licensing and Update Reports

Product Licensing

A combined 1390/5045 (28%) of NHP product license application submissions were refused from April to September 2021. 

  • Class I – 90% of product applications are meeting the 60-day performance timeline. The refusal rate for these is 14%. 
  • Class II – 90% of applications are meeting the 90-day performance timeline. The refusal rate for these is 36%.
  • Class III – 57% of applications are meeting the 210-day performance timeline. The refusal rate for these is 19%. There were about 200 Class III submissions that have not received an acknowledgment at the time of this posting. There is a Health Canada backlog of applications contributing to a delay in licensing timelines. 
  • Notifications – 99% of notifications received in 2020 have been completed. 46% of notifications received in 2021 have been completed. 

Product License Application Tips:

  • For a Class III application: be sure to include the reason for classification on the cover letter. 

Site Licensing

  • 213/362 (59%) site license submissions were refused during that time. (Apr to Sept 2021)
  • Stream 1 – 54% of applications are meeting the 35-day performance timeline. The refusal rate for these is 31%.
    Stream 2 – 87% of applications are meeting the 65-day performance timeline. The refusal rate for these is 36%.
  • Renewal – 162 complete renewals completed this year. The refusal rate for these is 36%.
  • Acknowledgement letter includes a built-in extension until a decision is reached. 
  • Health Canada expects to have site license renewals submitted in March 2021 to be completed by December 2021.

A risk-based approach is still taken on Site Licence renewals.

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Site License Application Tips:

  • Designated Party Authorizations and new site license application forms must be submitted via ePost to be considered. This is considered a secure portal. 
  • Applicants must use the most recent online Site License application form. 
  • Applicants must respond to all items in the Information Request Notice (IRN). Refer to each item by their number to organize your response for a higher success rate. 
  • Risk 2 or 3 observations are expected to be addressed via corrective and preventative actions (CAPA). This will be monitored on the next renewal. 
  • Guidance documents are available to help with site licensing and product/site quality. 
  • All documents should be separated into their own files and named appropriately. Applicants are suggested to name documents less than 15 characters. 
  • All site license applications should be screened and acknowledged within 10 days, a follow-up may be warranted after 30 days without a posted acknowledgment. 

Common Issues:

  • Failure to submit 30 days before site license expiry.
  • Failure to submit through the correct channel. ePost new applications tab. 
  • Failure to respond to an IRN on time. 
  • Failure to submit a complete and compliant application package. 
  • Addition of new sites during renewal. This should be done via amendment. Existing sites only in a renewal. 

Covid Site Licence Transition:

  • If a transition application was filed prior to the September 30th, 2021 deadline, sites can continue to operate until a decision has been reached. 
  • 107/174 sites submitted a transition application on time. Refusal rate of 35%
  • Reasons for refusal: No DPA, no GMP evidence, company code errors, missing application form. 
  • Companies that did not file for transition have been asked to confirm that activities have been ceased. 

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NHP System Updates:

  • Web Product License application form V4.3: release in winter 2022. This will include all monograph validation, improved kit submissions, improved NMI filtering, improved error messages
  • The decommissioning of the V3 PLA form will take place in winter 2022. You will no longer be able to finalize this form. You will be able to view and answer existing IRNs
  • There will be a short transition period to decommission the V3 form. Applicants are encouraged to use the V4 form now. This should result in fewer IRNs and a reduced refusal rate
  • Electronic site form: improvements are being made to assist in processing and screening for higher success rates and fewer IRNs. Improved in-form validation and a new notification table

Consultation on a Secure Portal:

  • A questionnaire for industry and associations will go out
  • Seeking consultation on features a secure portal would need
  • Your feedback is important, two weeks will be allotted

Informatics and Automation:

  • Improved monitoring for files entering post
  • Electronic forms reduce error rates. Allows for increased tracking and management of workload
  • Developing new automated tools. Enhancement of workload tracking and monitoring, identification of trends and forecasting, applying advanced analytics for optimization and efficiency
  • General Health, Traditional Chinese Medicine, and Live Microorganism claim to top the trend list over the last 3 years
  • Heart health, weight maintenance, and Skin, hair nail, claims are trending lower over the past 3 years
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