Status of Submissions Quarterly Report

This content was archived on June 24, 2013.

Quarter 4 (January 1, 2009 to March 31, 2009)

Natural Health Products Directorate
Health Canada

Help on accessing alternative formats, such as Portable Document Format (PDF), Microsoft Word and PowerPoint (PPT) files, can be obtained in the alternate format help section.

---

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 Quarterly 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 during Quarter 4 (January 1, 2009 to March 31, 2009)

• Chart 2 - Total Number of Product Licence Applications (PLAs) Licensed, Refused and Withdrawn during Quarter 4 (January 1, 2009 to March 31, 2009)

• Chart 3 - Total Number of Product Licence Applications (PLAs) Completed during Quarter 4 (January 1, 2009 to March 31, 2009) by Year of Application

• Chart 4 - Total Number of Product Licence Applications (PLAs) Received and Completed during Quarter 4 (January 1, 2009 to March 31, 2009)

• Chart 5 - Total Number of Product Licence Amendments and Notifications Received and Completed during Quarter 4 (January 1, 2009 to March 31, 2009)

• Chart 6 - Total Number of Site Licence Applications (SLAs) Received and Completed during Quarter 4 (January 1, 2009 to March 31, 2009)

• Chart 7 - Total Number of Site Licence Amendments, Notifications and Renewals Received and Completed during Quarter 4 (January 1, 2009 to March 31, 2009)

Status Update on the Product Licence Application Backlog

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 36,127 Product Licence Applications (PLAs). Of this total, 22,227 PLAs have been completed, including the issuance of 11,007 Product Licences.

Quarter 4 (January 1, 2009 to March 31, 2009)

During the past quarter, a total of 1675 PLAs were completed*, of which 557 were refused for the following reasons:

• 43% of PLAs failed to meet basic application requirements.
• 26% of PLAs were refused when applicants did not respond to a request for further information.
• 26% PLAs were refused when the applicant's response to a request for further information did not meet the requirements.
• 3% did not meet the definition of a NHP.
• 2% were refused when significant changes were made to the product itself in response to a request for further information (i.e. an "unsolicited change").

* As a result of a verification/correction of the data on the number of applications completed before Quarter 4 at the NHPD, please note that the total number of applications completed since January 2004 has increased by more than the1675 applications completed during this past quarter.

Statistics

Chart 1 - Total Number of Product Licence Applications (PLAs) Received and Completed during Quarter 4 (January 1, 2009 to March 31, 2009)

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 during Quarter 4 (January 1, 2009 to March 31, 2009)

Chart 3 - Total Number of Product Licence Applications (PLAs) Completed during Quarter 4 (January 1, 2009 to March 31, 2009) by Year of Application

Chart 4 - Total Number of Product Licence Applications (PLAs) Received and Completed during Quarter 4 (January 1, 2009 to March 31, 2009)

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 during Quarter 4 (January 1, 2009 to March 31, 2009)

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 during Quarter 4 (January 1, 2009 to March 31, 2009)

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 during Quarter 4 (January 1, 2009 to March 31, 2009)

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.

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.

With the implementation of the new simplified Information Request Notice (IRN) process and other improvement initiatives, the backlog now numbers 8230 PLAs, signalling a reduction of 35%.

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

Total Backlog	12,635 PLAs
Status	Number	Percentage of Total Backlog
Completed PLAs	4405 PLAs	35%
Licensed	1780	14%
Refused	1676	13%
Withdrawn	949	8%
Outstanding (Remaining Backlog)	8230 PLAs	65%
Undergoing an initial assessment against the evidence criteria.	3512	27.8%
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).	2712	21%
Undergoing a full assessment of safety, efficacy and quality.	1503	11.9%
Assessment complete.	503	4%

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