Status of Applications Quarterly Report

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Quarter 2 (July 1, 2010 to September 30, 2010)

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 NHPD.

Reporting Schedule*:

• 1st Quarter: April 1 to June 30
• 2nd Quarter: July 1 to September 30
• 3rd Quarter: October 1 to December 31
• 4th 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 PLA.info.DLMM@hc-sc.gc.ca.

Table of Contents

• Performance Summary and Highlights
• Quarter 2 (July 1, 2010 to September 30, 2010)
• Quarter 2 Statistics (July 1, 2010 to September 30, 2010)
  • Chart 1 - Total Number of PLAs Received and Completed during Quarter 2
  • Chart 2 - Total Number of PLAs Completed during Quarter 2 (Licensed, Refused or Withdrawn)
  • Chart 3 - Total Number of PLAs Completed during Quarter 2 (by Year of Application)
  • Chart 4 - Total Number of PLAs - by application type -Received and Completed during Quarter 2
  • Chart 5 - Total Number of Product Licence (PL) Amendments Received and Completed during Quarter 2
  • Chart 6 - Total Number of Product Licence (PL) Notifications Received and Completed during Quarter 2
  • Chart 7 - Total Number of Site Licence Applications (SLAs) Received and Completed during Quarter 2
  • Chart 8 - Total Number of Site Licence (SL) Amendments, Notifications and Renewals Received and Completed during Quarter 2
• Update on PLAs received before August 5, 2010 (pre-UPLAR)
  • Table 1: Total Product Licence Applications and Amendments received before August 5, 2010 which were not complete as of that date
  • Chart 9 - Pre-UPLAR Applications Not Complete by Application Type (n = 9282)
  • Chart 10 - Pre-UPLAR PLAs Not Complete: Ability to Sell (n = 9079)
• Update on PLAs received on or after August 5, 2010 (post-UPLAR)
  • Table 2: PLAs and Amendments received after August 5, 2010 which fully meet Pre-Cleared Information
  • Table 3: Breakdown of PLAs and Amendments received after August 5, 2010 which have received an Application Acceptance Letter or decision
  • Table 4: Status of PLAs and Amendments received after August 5, 2010 which have received an Application Acceptance Letter
  • Chart 11 - Post-UPLAR PLAs Not Complete (which do not fully meet pre-cleared information) by Application Type (n = 603)
• Appendix A - Acronyms and Definitions

Performance Summary and Highlights

New content of report

The content of this NHPD Status of Applications Quarterly Report has been changed to correspond with the coming into force of the Natural Health Products (Unprocessed Product Licence Applications) Regulations (NHP-UPLAR) on August 4, 2010 and the publication of performance targets related to Product Licence Applications (PLAs) in the NHPD Application Management Policy on August 9, 2010 .  Appendix A has been updated to reflect explanations of new acronyms and definitions of new terms used in this report.

History of the Natural Health Product Directorate's (NHPD's) "backlog"

Since the NHP Regulations came into force in January 2004, 54,836 PLAs have been received at NHPD.  Since 2008, the number of applications completed each year has exceeded the number of applications received.  However, in the years previous, the number of applications received far exceeded the number of applications completed per year.  This created a significant number of PLAs which had not been assessed by NHPD. 

In 2008, in order to more accurately report progress on applications, "backlog" was defined by NHPD as the number of PLAs received before April 1, 2008 which had not been completed as of that date.  The number was 12,976 PLAs.  Applications received after April 1, 2008 were referred to as "regular workload".  All application status reports, including previous Quarterly Reports, were updated to reflect those two distinct categories of applications. 

Moving forward with the Natural Health Products (Unprocessed Product Licence Applications) Regulations (NHP-UPLAR)and Application Management Policy

The coming into force of NHP-UPLAR on August 4, 2010, provides a mechanism for PLAs received prior to this date and not yet completed by NHPD (pre-UPLAR PLAs) to be legally sold on condition that the application has been with NHPD for more than 180 days, the product is not subject to risk factor criteria as set out in NHP-UPLAR, the applicant has applied for and received an Exemption Number (EN), and the PLA was not previously withdrawn by the applicant.  These pre-UPLAR PLAs are or will be eligible for ENs except for 603 applications which fall within the risk factor criteria categories.  The authorization to legally sell pre-UPLAR products with ENs will be in place until the application is licensed, refused or withdrawn by the applicant. 

Since the majority of pre-UPLAR PLAs will be eligible for an EN and can be legally sold,  NHPD will be prioritizing the assessment of these PLAs based on a variety of factors including the complexity of the product, the significance of the claim being made for the product, the number of and significance of the ingredients in the product, and the date the PLA was received at NHPD.  Due to the fact that UPLAR will be repealed in February 2013, it is incumbent upon NHPD to reach a regulatory decision on all the pre-UPLAR PLAs prior to this date.  

For PLAs received on or after August 5th, 2010 (post-UPLAR PLAs), NHPD will report against the newly published performance targets set out in the NHPD Application Management Policy and the objective will be to meet these performance targets for each application.

As a result, commencing with this Quarterly Report, NHPD will therefore change the way it reports on the progress of PLAs.  NHPD will now report on two types of product licence applications:

1. applications received before UPLAR came into force (pre-UPLAR PLAs), and
2. applications received after UPLAR came into force (post-UPLAR PLAs).

The terms "backlog" and "regular workload" will no longer be used.

Overall Product Licence Application Statistics Summary

As mentioned above, NHPD has received 54,836 PLAs from January 1, 2004 to September 30, 2010.  Of this total, 44,285 (81%) PLAs have been completed, including the issuance of 24,442 Product Licences representing 32,413 products. The remaining completed applications were either refused by NHPD or withdrawn by the applicant.  In total, 1258 companies have received a product licence to date.

Pre-Unprocessed Product Licence Application Regulations Product Licence Application Statistics Summary

Of the 10,885 PLAs and amendments received before August 5th, 2010 (pre-UPLAR PLAs) which were not completed prior to that date, 15% have now been completed or are in the process of being completed.   NHPD is committed to completing the remaining 9283 applications before NHP-UPLAR is repealed in February 2013. 

Post-Unprocessed Product Licence Application Regulations Product Licence Application Statistics Summary

Of the 1,424 applications and amendments received on and after August 5th, 2010 (post-UPLAR PLAs), 40% fully meet NHPD's pre-cleared information and are subject to completion within 60 days of receipt.  The remaining 60% are subject to completion via the full assessment process within 180 days of being accepted by NHPD.

Overall Site Licence Application Statistics Summary

NHPD has received 1676 Site Licence Applications (SLAs) from January 1, 2004 to September 30, 2010.  Of this total, 1604 (96%) SLAs have been completed, including the issuance of 1070 Site Licences.  The remaining completed applications were either refused by NHPD or withdrawn by the applicant.   A total of 1806 Site Licence Renewals have been received.  95% of all Site Licence Renewals have been completed.

Quarter 2 Statistics (July 1, 2010 to September 30, 2010)

During this quarter, a total of 2874 PLAs were completed, 56% (1623) of these completions resulted in product licences, 36% (1025) were refusals and the remaining 8% (226) of completions were as a result of the applicant withdrawing the application.

Of the 1025 applications refused this quarter, the reasons were as follows:

• 49% failed to meet basic application requirements.
• 35% were refused when the applicant's response to a request for further information did not meet the requirements.
• 12% were refused when applicants did not respond to a request for further information.
• 2% were refused for containing an ingredient not listed in the

Natural Health Products Ingredient Database NHPID).

• 1% were refused when quality, safety and/or efficacy issues were identified.
• 1% did not meet the definition of a NHP.
• <1% were refused as a result of significant changes having been made to the product itself in response to a request for further information (i.e. an "unsolicited change").

Quarter 2 Statistics (July 1, 2010 to September 30, 2010)

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 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 Product Licence (PL) Notifications Received and Completed during Quarter 2

Chart 7 - 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 8 - 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's received before August 5, 2010 (pre-Unprocessed Product Licence Applications Regulations)

This section provides figures on the current status of PLAs which were received before August 5, 2010 and not complete as of that date.  All applications received after this date will be measured against NHPD's performance targets (see Tables 2 and 3).  These performance targets were communicated to applicants via the NHPD Application Management Policy.   Please note these numbers also include product licence amendments.

As shown in Table 1 below, the number of applications remaining at NHPD as of August 5, 2010 was 10,885.  The number remaining as of September 30, 2010 is 9282.  The objective is to complete the remaining 9283 before NHP-UPLAR is repealed in February 2013.    At the same time, NHPD will be focused on completing all applications received on or after August 5, 2010 in accordance with the performance targets communicated in the Application Management Policy.

Table 1: Total Product Licence Applications and Amendments received before August 5, 2010 which were not complete as of that date

Status	Number	% of Total (10,885)
Licensed	525
In Licensing - administrative processing required	262
Refused	413
To Be Refused - administrative processing required	246
Withdrawn by applicant	157
Total Completed	1602	14.7%
Full Assessment in progress	1456
With Applicant pending response to IRN	288
Total Undergoing Full Assessment	1744	16.0%
In Queue for Full Assessment	3864
Initial Assessment not yet completed	1029
Total In Queue for Full Assessment	4893	45.0%
Halted pending internal decision related to safety or efficacy	2599
Miscellaneous Administrative Issues	46
Total Other	2645	24.3%

Chart 9 - Pre-Unprocessed Product Licence Applications Regulations Applciations Not Complete by Application Type (n=9282)

Chart 10 - Pre-Unprocessed Product Licence Applications Regulations Product Licence Applications Not Complete: Ability to sell (n=9079)

 

Update on Product Licence Applications received on or after August 5, 2010 (post-Unprocessed Product Licence Applications Regulations)

This section provides figures on the current status of PLAs which were received on or after August 5, 2010.  All applications received after this date will be measured against NHPD's performance targets.  These performance targets were communicated to applicants via the NHPD Application Management Policy.   Please note these numbers also include product licence amendments.

For the purposes of the performance targets, these applications are separated into two categories: those which fully meet pre-cleared information and those which do not fully meet pre-cleared information.  Pre-cleared information includes NHPD Monographs, Labelling Standards and Abbreviated Labelling Standards.  Products falling within the parameters described in these documents are subject to shorter review times.  See Appendix A for the definition of pre-cleared information.

Applications fully meeting pre-cleared information (60 day review target)

The performance on these applications is outlined in Table 2 below.  For these types of applications, NHPD has consistently met the 60-day performance target for some time and continues to do so.  Please note that this table only includes amendments supported by pre-cleared information.

Table 2: Product Licence Applications and Amendments received after August 5, 2010 which fully meet Pre-Cleared Information

Application Type	Received	Completed since August 5, 2010	% Completed within 60 days	PLAs in progress
Compendial	500	84	100%	416
Labelling Standards	38	1	100%	37
Abbreviated Labelling Standards	4	0	N/A	4
Amendments	31	20	100%	11
Total	573	105	100% (average)	468

Applications not fully meeting pre-cleared information (30 day review target for Administrative Processing and Initial Assessment)

For these types of applications, NHPD's objective is to perform the administrative processing and initial assessment within a 30 day timeframe as described in the Application Management Policy. This 30 day target applies only to applications and amendments received on or after August 5, 2010.  At the end of the 30 day timeframe, applicants receive an Application Acceptance Letter or a Notice of Refusal - Initial Assessment.  The performance on these applications is outlined in Table 3 below. 

Of the 851 applications received on or after August 5, 2010 which do not fully meet pre-cleared information, 536 (63%) have received an Application Acceptance Letter or decision.  In 97% of cases, this was completed within the 30 day target.

Table 3: Breakdown of Product Licence Applications and Amendments received after August 5, 2010 which have received an Application Acceptance Letter or decision

Action	Count	% of Total (536)
Application Acceptance Letter issued	328	61%
Product Licence issued	9	2%
Notice of Refusal - Initial Assessment issued	194	36%
Withdrawn by the Company	5	1%

Of the 315 applications which have not yet received an Application Acceptance Letter or decision, 99% were received less than 30 days ago and thus, are currently undergoing Administrative processing or Initial Assessment by NHPD.

Applications not fully meeting pre-cleared information (180 day review target for Full Assessment)

For these types of applications, NHPD's objective is to meet the 180 day review target as described in the Application Management Policy. This 180 day target applies only to applications and amendments received on or after August 5, 2010 that have been issued an Application Acceptance Letter.  Please note that future quarterly reports will provide more detail in regards to the 180 day timeline and the percentage of applications completed within that timeline as this Quarterly Report only represents the initial 57 days of performance monitoring at NHPD (August 5 - September 30). 

Table 4 outlines the status of the 342 PLAs received after August 5, 2010 that were issued an Application Acceptance Letter and are therefore subject to NHPD's 180 day performance target for full assessment as outlined in the Application Management Policy.  Note that the 194 applications mentioned above received a Notice of Refusal - Initial Assessment and are thus not included in Table 4.

Table 4: Status of Product Licence Applications and Amendments received after August 5, 2010 which have received an Application Acceptance Letter

Status	Number	% of Total (328)
Total Completed	0	0.0%
Has received at least one request for further information	78
Full Assessment in progress	206
Total In Full Assessment	284	86.6%
Halted pending internal decision related to safety or efficacy	44
Total Other	44	13.4%

Chart 11 - Post-Unprocessed Product Licence Applications Regulations Product Licence Applications Not Completed (which do not fully meet pre-cleared information) by Application Type (n=603)

Appendix A - Acronyms and Definitions  

PL:

Product Licence

SL:

Site Licence

PLA:

Product Licence Application

SLA:

Site Licence Application

NHPD:

Natural Health Products Directorate

Abbreviated Labelling Standard (AbLS):

Document created by NHPD outlining information about the established safety and / or efficacy of a product or ingredient.  AbLS is one type of pre-cleared information.

Amendment:

Product Licence Application proposing revisions to an existing product licence

HM PLA:

Homeopathic Medicines Product Licence Application

Labelling Standard (LS):

Document created by NHPD outlining information about the established safety and efficacy of a type of product.  LS is one type of pre-cleared information.

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

Compendial PLA:

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

Application Management Policy:

The Application Management Policy outlines the way in which Product Licence Applications for natural health products are submitted in accordance with the Natural Health Products Regulations. The policy also outlines the responsibilities and expectations for natural health product applicants before and throughout the application review process. In addition, the policy outlines the proposed performance targets for the management of all types of product licence applications.  This policy is available on NHPD's website and applies to all product licence applications submitted after August 5, 2010.

Completed:

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

Halted:

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

Initial Assessment:

An assessment of the evidence in support of safety, efficacy and quality to ensure that the requisite information for the type of application in question, as defined in the Natural Health Product Regulations and as described in various guidance documents has been submitted.

An Application Acceptance Letter is issued when the information and material submitted are deemed complete and are acceptable for full assessment.

Alternatively, if deficiencies are identified during the initial assessment, a Refusal Letter - Initial Assessment will be issued.

For applications received on or after August 5, 2010, this assessment is performed within 30 days of receipt of the application.  This assessment is performed only for applications which do not fully meet pre-cleared information.

Information Request Notice (IRN):

A notice sent from NHPD to an applicant requesting additional information to support the safety, efficacy or quality of a product.  As outlined in the Application Management Policy, this notice is sent during the Full Assessment stage and the applicant has 30 days to respond.  Applicants can contact the Submission Coordinator indicated on the notice with questions or clarifications.

Natural Health Products (Unprocessed Product Licence Applications) Regulations:

Also referred to as UPLAR or NHP-UPLAR.  These Regulations allow for certain products to be issued exemption numbers by Health Canada.  In order to qualify, products must: have had a complete product licence application (PLA) submitted; not have been withdrawn; still be with Health Canada for a final licensing decision; and not fall within certain risk criteria. Products for which an exemption number is issued by Health Canada will be exempted from the current prohibition against sale without a product licence (as set out in s.4 of the Natural Health Products Regulations). In other words, these products can now be sold legally.  These Regulations were registered on August 4, 2010 and will be repealed 30 months following that date on February 4, 2013.

Pre-Cleared Information:

Information which has been pre-cleared by the NHPD includes NHPD Monographs, Labelling Standards and Abbreviated Labelling Standards.  These documents outline the parameters under which a product can be sold including allowable claims, dose limits and risk information required on the product label.  If a company wishes to receive a licence and their product falls within the parameters of any of these documents, the licence can be issued in 60 days.  Pre-cleared information can also be used to help support other applications types; for example, one ingredient within a multi-ingredient product may be supported by a monograph for that ingredient.

UPLAR:

See definition of Natural Health Products (Unprocessed Product Licence Applications) Regulations above.

Pre-UPAR PLAs:

Product Licence Applications received prior to the publication of the Natural Health Products (Unprocessed Product Licence Applications) Regulations on August 5th, 2010 which were not yet complete as of that date

Post-UPLAR PLAs:

Product Licence Applications received on or after August 5th, 2010.   These applications are subject to the performance targets set out in Application Management Policy.