Status of Applications Quarterly Report

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Quarter 2 (July 1, 2009 to September 30, 2009)

Natural Health Products Directorate
Health Canada

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The Status of Applications 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.

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 Applications Quarterly Report may be addressed to the Natural Health Products Directorate

Table of Contents

• Performance Summary and Highlights
• Quarter 2 (July 1, 2009 to September 30, 2009
• Statistics: Quarter 2 (July 1, 2009 to September 30, 2009)
  • Chart 1 - Total Number of Product Licence Applications (PLAs) Received and Completed during Quarter 2
  • Chart 2- Total Number of Product Licence Applications (PLAs) Completed during Quarter 2 (Licensed, Refused and Withdrawn)
  • Chart 3 - Total Number of Product Licence Applications (PLAs) Completed during Quarter 2 (by Year of Application)
  • Chart 4 - Total Number of Product Licence Applications (PLAs) - by application type -Received and Completed during Quarter 2
  • Chart 5 - Total Number of Product Licence (PL) Amendments and Notifications Received and Completed during Quarter 2
  • Chart 6 - Total Number of Site Licence Applications (SLAs) Received and Completed during Quarter 2
  • Chart 7 - Total Number of Site Licence (SL) Amendments, Notifications and Renewals Received and Completed during Quarter 2
• Update on the Product Licence Application "Backlog" and "Regular Workload"
  • Table 1: Total "Backlog" as of September 30, 2009
  • Table 2: Total "Regular Workload" as of September 30, 2009
• Appendix A - Acronyms and Definitions

Performance Summary and Highlights

Since the implementation of the Natural Health Products Regulations in January 2004 until the end of September 2009, Health Canada has received 41,872 Product Licence Applications (PLAs). Of this total, 30,464 PLAs have been completed, including the issuance of 15,790 Product Licences which represents 20,674 products. The remaining completed applications were either refused by NHPD or withdrawn by the applicant.  In total, 977 companies have received a product licence to date.

The number of PLAs completed by NHPD per quarter has continued to rise during Quarter 2 (FY 09-010) to 4717, surpassing the 3520 from Quarter 1(FY 09-10) by 34%. As of September 30, 2009, 839 applications remained in the administrative processing queue for issuance of licences and 221 applications for issuance of a refusal.

To date, 59% of applications in "backlog" and 67% of "regular workload" applications have been completed or are in the process of being completed. In addition, 82% of "backlog" applications and 77% of "regular workload" applications have been addressed (see Appendix A for definitions).

During this quarter, the reduction in the number of non-addressed backlog applications by 9.5% is largely as a result of the following:

• Process improvements implemented in the Non-Traditional application review stream
• Addition of administrative resources to minimize delays in communicating decisions to applicants.

While the priority is addressing backlog applications, NHPD continues to report improvement with regards to regular workload applications. Only 23% of applications received since April 1, 2008 have not yet been addressed, an improvement of 7% over the previous quarter which is largely a result of:

• The use of NHPD-developed pre-cleared information such as NHPD Labelling Standards and Monographs by applicants as a tool to expedite applications
• Process improvements implemented in order to expedite Transitional DIN & Compendial applications
• The implementation of the Initial Assessment process for incoming Non-Traditional submissions within a few months after receipt

Quarter 2 (July 1, 2009 to September 30, 2009)

During this quarter, a total of 4717 PLAs were completed, 1540 of which were refused for the following reasons:

• 49% were refused when applicants did not respond to a request for further information.
• 42% failed to meet basic application requirements.
• 7% were refused when the applicant's response to a request for further information did not meet the requirements.
• 1% did not meet the definition of a NHP.
• 1% were refused when significant changes were made to the product itself in response to a request for further information (i.e. an "unsolicited change").

Quarter 2 Statistics (July 1, 2009 to September 30, 2009)

Chart 1 - Total Number of Product Licence Applications (PLAs) Received and Completed during Quarter 2

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

Chart 2 - Total Number of Product Licence Applications (PLAs) Completed during Quarter 2 (Licensed, Refused or Withdrawn)

Chart 3 - Total Number of Product Licence Applications (PLAs) Completed during Quarter 2 (by year of application)

Chart 4 - Total Number of Product Licence Applications (PLAs)-by application type-Received and Completed during Quarter 2

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

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

Chart 5 - Total Number of Product Licence (PL) Amendments and Notifications Received and Completed during Quarter 2

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

Chart 6 - Total Number of Site Licence Applications (SLAs) Received and Completed during Quarter 2

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

Chart 7 - Total Number of Site Licence (SL) Amendments, Notifications and Renewals Received and Completed during Quarter 2

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

Update on the Product Licence Application "Backlog" and "Regular Workload"

As defined by the NHPD, the "backlog" consists of the 12,635 PLAs received before April 1, 2008 which were incomplete as of that date (i.e. the PLA was not licensed, withdrawn or refused). All other PLAs received on or 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. For the purposes of reporting, these are called "regular workload" PLAs.

As a result of the implementation of the Non-Traditional Process Improvement Project and other improvement initiatives, the number of incomplete "backlog" PLAs now equals 5131 PLAs, signalling a reduction of 59.4% from the original 12,635 PLAs.

Table 1: Total "Backlog" as of September 30, 2009

Table 1 provides figures on the current status of the PLA "backlog". Please note these numbers do not include amendments, notifications or applications relating to those natural health products in food formats that have yet to be classified as either foods or natural health products.

Status	Number	Percentage of Total "Backlog" (12,635)
Licensed	2502
In Licensing - administrative processing required	44
Refused	2763
To Be Refused - administrative processing required	110
Withdrawn by applicant	2085
Addressed PLAs - Completed	7507	59.4%
Has received one or more Information Request Notice (IRN) or E-IRN	2891
Addressed PLAs - Other	2891	22.9%
Require Initial Assessment to determine if file requires E-IRN	176
To receive E-IRN	64
Awaiting or undergoing full review	1063
Halted pending internal decision related to safety or efficacy	937
Non-Addressed PLAs	2240	17.7%

Table 2: Total "Regular Workload" as of September 30, 2009

Table 2 provides figures on the current status of all PLAs which were received on or after April 1, 2008 and are therefore not considered "backlog". Please note these numbers do not include amendments, notifications or applications relating to those natural health products in food formats that have yet to be classified as either foods or natural health products.

Status	Number	Percentage of Total "Regular workload" (15,727)
Licensed	7101
In Licensing - administrative processing required	795
Refused	2140
To Be Refused - administrative processing required	109
Withdrawn by applicant	366
Addressed PLAs - Completed	10511	66.8%
Has received one or more Information Request Notice (IRN) or E-IRN	1551
Addressed PLAs - Other	1551	9.9%
Applications (all types) recently received at NHPD	537
Require Initial Assessment to determine if file requires E-IRN	527
To receive E-IRN	53
Awaiting or undergoing full review	2050
Halted pending internal decision related to safety or efficacy	483
Miscellaneous Administrative Issues	15
Non-Addressed PLAs	3665	23.3%

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

Addressed:

When NHPD issues a Product Licence, Notice of Refusal, Information Request Notice or when the applicant withdraws their application, the application is considered to be "addressed".

Backlog:

All PLAs received before April 1, 2008 which were not complete as of that date

Completed:

When NHPD issues a Product Licence, Notice of Refusal or when the applicant withdraws their application, the application is considered to be "completed".

E-IRN:

Information Request Notice focusing on critical evidence deficiencies

Halted:

An application which cannot be further processed due to the need for an internal decision related to safety and/or efficacy

IRN:

Information Request Notice

Non-Traditional Process Improvement Project:

Project initiated by NHPD, in 2008, which involves screening Non-Traditional applications for critical evidence deficiencies through an initial assessment process

Regular workload:

All PLAs received on or after April 1, 2008