Status of Applications/Submissions Quarterly Report

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Quarter 1 (April 1, 2009 to June 30, 2009)

Natural Health Products Directorate
Health Canada

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The Status of Applications/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.

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/Submissions Quarterly Report may be addressed to NHPD_DPSN@hc-sc.gc.ca

Table of Contents

• Performance Summary and Highlights
• Statistics: Quarter 1 (April 1, 2009 to June 30, 2009)
  • Chart 1 - Total Number of Product Licence Applications (PLAs) Received and Completed
  • Chart 2 - Total Number of Product Licence Applications (PLAs) Completed (Licensed, Refused and Withdrawn)
  • Chart 3 - Total Number of Product Licence Applications (PLAs) Completed (by Year of Application)
  • Chart 4 - Total Number of Product Licence Applications (PLAs) - by application type -Received and Completed
  • Chart 5 - Total Number of Product Licence (PL) Amendments and Notifications Received and Completed
  • Chart 6 - Total Number of Site Licence Applications (SLAs) Received and Completed
  • Chart 7 - Total Number of Site Licence (SL) Amendments, Notifications and Renewals Received and Completed
• Status Update on the Product Licence Application "Backlog" and "Regular Workload"
  • Table 1: Total "Backlog" as of June 30, 2009
  • Table 2: Total "Regular Workload" as of June 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 June 2009, Health Canada has received 38,255 Product Licence Applications (PLAs). Of this total, 25,747 PLAs have been completed, including the issuance of 13,143 Product Licences. The remaining completed applications were either refused by NHPD or withdrawn by the applicant.

As a result of an increase in the number of administrative staff, there was a significant increase in the number of PLAs that NHPD was able to complete during Quarter 1 (Fiscal year 09-10) - in fact, this number more than doubled from 1675 in Quarter 4 (Fiscal year 08-09) to 3520 in Quarter 1. As of June 30, 2009, 765 applications remain in the administrative processing queue for issuance of licences and 238 applications for issuance of a refusal.

To date, 47% of applications in "backlog" and 59% of "regular workload" applications have been or are in the process of being completed. In addition, 73% of "backlog" applications and 69% of "regular workload" applications have been addressed (see Appendix A for definitions).

In addition to the information previously included in each quarterly report, there are now several new components which are intended to enhance and improve the report. These new components are summarized below:

• Comparison to previous quarter: Some tables now include comparison data between the current and previous quarter.
• Addition of new application type: The newest application type - Labelling Standard - is now reflected as a distinct category in Chart 4.
• Added "regular workload" table: A new table has been added to reflect applications received at NHPD on or after April 1, 2008.
• Refining of categories in "backlog" summary tables: The "backlog" and "regular workload" application status reports have been refined to include more detailed explanations of application status.
• Revised definition list: On the final page of this report, you will find an expanded definition list including definitions for terms such as addressed and completed, E-IRN and IRN, and "backlog" and "regular workload".

Quarter 1 (April 1, 2009 to June 30, 2009)

During this quarter, a total of 3520 PLAs were completed, of which 779 were refused for the following reasons:

• 50% failed to meet basic application requirements.
• 35% were refused when applicants did not respond to a request for further information.
• 10% 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").
• Less than 1% were refused as a result of safety and/or quality issues

Quarter 1 Statistics (April 1, 2009 to June 30, 2009)

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

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

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

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

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

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 Amendments and Notifications Received and Completed

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

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

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

Status 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 6661 PLAs, signalling a reduction of 47.3% from the original 12,635 PLAs.

Table 1: Total "Backlog" as of June 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	2217
In Licensing - administrative processing required	66
Refused	2038
To Be Refused - administrative processing required	109
Withdrawn by applicant	1544
Addressed PLAs - Completed	5974	47.3%
Has received one or more Information Request Notice (IRN) or E-IRN	3220
Addressed PLAs - Other	3220	25.5%
Require Initial Assessment to determine if file requires E-IRN	170
To receive E-IRN	45
Awaiting or undergoing full review	2063
Halted pending internal decision related to safety or efficacy	1138
Miscellaneous Administrative Issues	25
Non-Addressed PLAs	3441	27.2%

Table 2: Total "Regular Workload" as of June 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" (11,908)
Licensed	4754
In Licensing - administrative processing required	688
Refused	1331
To Be Refused - administrative processing required	122
Withdrawn by applicant	177
Addressed PLAs - Completed	7072	59.4%
Has received one or more Information Request Notice (IRN) or E-IRN	1203
Addressed PLAs - Other	1203	10.1%
Applications (all types) recently received at NHPD	348
Require Initial Assessment to determine if file requires E-IRN	265
To receive E-IRN	115
Awaiting or undergoing full review	2394
Halted pending internal decision related to safety or efficacy	483
Miscellaneous Administrative Issues	28
Non-Addressed PLAs	3633	30.5%

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:

Any PLA which has been issued a Product Licence, Refusal, Information Request Notice or has been withdrawn by the applicant.

Backlog:

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

Complete:

Any PLA which has been issued a Product Licence, Notice of Refusal or which has been withdrawn by the applicant

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