Status of Submissions Quarterly Report

This content was archived on June 24, 2013.

Quarter 3 (October 1, 2008 to December 31, 2008)

Natural Health Products Directorate (NHPD)
Health Canada

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The Status of Submissions Quarterly Report is a publication of Health Canada's Natural Health Products Directorate (NHPD), the federal department responsible for the regulation of natural health products sold in Canada.  The purpose of this report is to provide the Canadian public with statistical data on the product and site licence applications received and processed by the NHPD.

The Status of Submissions Report is released every quarter to the Canadian public via the NHPD's electronic bulletin. Subscribe to the NHPD e-bulletin.

Reporting Schedule*:

• 1^st Quarter: April 1 to June 30
• 2^nd Quarter: July 1 to September 30
• 3^rd Quarter: October 1 to December 31
• 4^th Quarter: January 1 to March 31

*Based on fiscal year, not calendar year.

Questions, comments or feedback regarding the content of the Status of Submissions Quarterly Report may be addressed to NHPD_DPSN@hc-sc.gc.ca

Table of Contents

Performance Summary and Highlights

Statistics

• Chart 1 - Total Number of Product Licence Applications (PLAs) Received and Completed for Quarter 3 (October 1, 2008 to December 31, 2008)

• Chart 2 - Total Number of Product Licence Applications (PLAs) Licensed, Refused and Withdrawn for Quarter 3 (October 1, 2008 to December 31, 2008)

• Chart 3 - Total Number of Product Licence Applications (PLAs) Completed by Year of Application for Quarter 3 (October 1, 2008 to December 31, 2008)

• Chart 4 - Total Number of Product Licence Applications (PLAs) Received and Completed for Quarter 3 (October 1, 2008 to December 31, 2008)

• Chart 5 - Total Number of Product Licence Amendments and Notifications Received and Completed for Quarter 3 (October 1, 2008 to December 31, 2008)

• Chart 6 - Total Number of Site Licence Applications (SLAs) Received and Completed for Quarter 3 (October 1, 2008 to December 31, 2008)

• Chart 7 - Total Number of Site Licence Amendments, Notifications and Renewals Received and Completed for Quarter 3 (October 1, 2008 to December 31, 2008)

Appendix A - Acronyms and Definitions

Performance Summary and Highlights

Since the implementation of the Natural Health Products Regulations in January 2004, Health Canada has received 33,312 Product Licence Applications (PLAs). Of this total, over 20,500 PLAs have been completed, including the issuance of 10,344 Product Licences.

Reasons for Refusal

During the past quarter, a total of 1920 PLAs were completed, of which 394 were refused for the following reasons:

• 35% of PLAs failed to meet basic application requirements.
• 32% of PLAs were refused when applicants did not respond to a request for further information.
• 24% PLAs were refused when the applicant's response to a request for further information did not meet the requirements.
• 3% were refused when significant changes were made to the product itself in response to a request for further information (i.e. an "unsolicited change").
• 5% did not meet the definition of a NHP.

Status Update on the Product Licence Application Backlog

As defined by the NHPD, the backlog consists of all PLAs received before April 1, 2008 which were incomplete as of that date. "Incomplete" includes PLAs for which the NHPD had not rendered a regulatory decision (i.e. the PLA was not licensed, withdrawn or refused) by April 1, 2008. All other PLAs received after April 1, 2008 are considered regular workload and are not part of the PLA backlog the NHPD has committed itself to addressing by March 31, 2010.

Health Canada has set a performance goal to address 60% of the total PLA backlog by March 31, 2009. The remaining 40% will be addressed by March 31, 2010.

Working from this date, On April 1, 2008, the backlog consisted of 12,635 PLAs. Since that time, with the implementation of the new simplified Information Request Notice (IRN) process and other improvement initiatives, the backlog now numbers 8741 PLAs, a reduction of 33%.

Of the remaining PLAs in backlog, significant progress is being made on completing the assessment of these files. The majority of the PLAs in backlog are actively being reviewed and companies are engaged through IRNs. In some cases, the NHPD is awaiting further information from a company in order to proceed with the submission.

The table below provides figures on the current status of the PLA backlog.

Total Backlog	12,635 Product Licence Applications (PLAs)
Status	Number	Percentage of Total Backlog
Completed PLAs	4176 PLAs	33%
Licensed	1921	15%
Refused	1609	12%
Withdrawn	646	5%
Outstanding (Remaining Backlog)	8741 PLAs	67%
Undergoing an initial assessment against the evidence criteria.	3739	29.6%
Have been placed in the appropriate review stream and are awaiting a full assessment of their safety, efficacy and quality (this includes PLAs that have undergone an initial assessment against the evidence criteria).	2990	23.7%
Undergoing a full assessment of safety, efficacy and quality.	1730	13.7%

Statistics

Chart 1 - Total Number of Product Licence Applications (PLAs) Received and Completed for Quarter 3 (October 1, 2008 to December 31, 2008)

Note - "Completed" includes all submissions that were licensed, refused or withdrawn by the applicant.

Chart 2 - Total Number of Product Licence Applications (PLAs) Licensed, Refused and Withdrawn for Quarter 3 (October 1, 2008 to December 31, 2008)

Chart 3 - Total Number of Product Licence Applications (PLAs) Completed by Year of Application for Quarter 3 (October 1, 2008 to December 31, 2008)

Chart 4 - Total Number of Product Licence Applications (PLAs) Received and Completed for Quarter 3 (October 1, 2008 to December 31, 2008)

Note - "Completed" includes all submissions that were licensed, refused or withdrawn by the applicant.  

* Refer to Appendix A for definitions of acronyms found in Chart 4.

Chart 5 - Total Number of Product Licence Amendments and Notifications Received and Completed for Quarter 3 (October 1, 2008 to December 31, 2008)

Note - "Completed" includes all submissions that were licensed, refused or withdrawn by the applicant.

* Refer to Appendix A for definitions of acronyms found in Chart 5.

Chart 6 - Total Number of Site Licence Applications (SLAs) Received and Completed for Quarter 3 (October 1, 2008 to December 31, 2008)

Note - "Completed" includes all submissions that were licensed, refused or withdrawn by the applicant.

Chart 7 - Total Number of Site Licence Amendments, Notifications and Renewals Received and Completed for Quarter 3 (October 1, 2008 to December 31, 2008)

Note - "Completed" includes all submissions that were licensed, refused or withdrawn by the applicant.

* Refer to Appendix A for definitions of acronyms found in Chart 7.

 Appendix A - Acronyms and Definitions

PL: Product Licence

SL: Site Licence

PLA: Product Licence Application

SLA: Site Licence Application

DIN: Drug Identification Number

NHPD: Natural Health Products Directorate

HM PLA: Homeopathic Medicines Product Licence Application

Non-Trad. PLA: Non-Traditional Product Licence Application

Trad. PLA: Traditional Product Licence Application

TPD Cat IV / Label Standard PLA: Product Licence Application citing a Category IV Monograph or Labelling Standard from the Therapeutic Products Directorate

Trans-DIN PLA: Transitional DIN Product Licence Application

Compendial PLA: Product Licence Application citing a monograph found in the NHPD's Compendium of Monographs