Status of Applications Quarterly Report

Quarter 3 (October 1, 2011 to December 31, 2011)

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 licence, site licence and clinical trial applications received and processed by 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 Product Licensing.

Table of Contents

• Performance Summary and Highlights
• Quarter 3 (October 1, 2011 to December 31, 2011)
• Quarter 3 Statistics (October 1, 2011 to December 31, 2011)
  • Chart 1 - Total Number of PLAs Received and Completed during Quarter 3 compared to Quarter 2
  • Chart 2 - Total Number of PLAs Completed during Quarter 3 compared to Quarter 2 (Licensed, Refused or Withdrawn)
  • Chart 3 - Total Number of PLAs Completed during Quarter 3, Pre vs. Post UPLAR (n=2230)
  • Chart 4 - Total Number of PLAs - by application type -Received and Completed during Quarter 3
  • Chart 5 - Total Number of Product Licence (PL) Amendments Received and Completed during Quarter 3 compared to Quarter 2
  • Chart 6 - Total Number of Product Licence (PL) Notifications Received and Completed during Quarter 3 compared to Quarter 2
  • Chart 7 - Total Number of Site Licence Applications (SLAs) Received and Completed during Quarter 3 compared to Quarter 2
  • Chart 8 - Total Number of Site Licence (SL) Amendments, Notifications and Renewals Received and Completed during Quarter 3
    
    
• 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=6168)
  • Chart 10 - Pre-UPLAR PLAs Not Complete: Ability to Sell (n=6135)
    
    
• Update on PLAs received on or after August 5, 2010 (post-UPLAR)
  • Table 2: PLAs and Amendments completed in Quarter 3 that fully meet Pre-Cleared Information
  • Table 3: Breakdown of PLAs and Amendments for which an Application Acceptance Letter or decision was issued during Quarter 3
  • Chart 11 - Initial Assessment in Quarter 3: Acceptance versus Refusal (n=1178)
  • Table 4: Breakdown of PLAs and Amendments which require full assessment that were completed during Quarter 3
  • Table 5: Status of all PLAs and Amendments received after August 5, 2010 which have received an Application Acceptance Letter
  • Chart 12 - Post-UPLAR PLAs not yet complete which have received an Application Acceptance Letter by Application Type (n=1890)
    
    
• Appendix A - Acronyms and Definitions

Performance Summary and Highlights

Format and content of report

NHPD's Quarterly Report reflects 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.

NHPD reports on two types of product licence applications:

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

Overall Product Licence Application Statistics Summary

NHPD has received 66,293 PLAs from January 1, 2004 to December 31, 2011. Of this total, 57,348 (87%) PLAs have been completed, including the issuance of 31,704 Product Licences representing 44,737 products. The remaining completed applications were either refused by NHPD or withdrawn by the applicant. In total, 1603 companies have received a product licence to date.

Pre-UPLAR Product Licence Application Statistics Summary

Of the 10,885 PLAs and amendments received before August 5th, 2010 (pre-UPLAR PLAs) and which had not been completed prior to that date, 4,717 (43%) have now been completed. NHPD is committed to completing the remaining 6,168 applications before NHP-UPLAR is repealed in February 2013.

Post-UPLAR Product Licence Application Statistics Summary

Of the 14,381 applications and amendments received on and after August 5^th, 2010 (post-UPLAR PLAs), 48% fully meet NHPD's pre-cleared information (60 day review target) and the remaining 52% require full assessment (180 days review target).

During Quarter 3, NHPD met performance targets as follows:

• 30 day initial assessment: 81%
• 60 day pre-cleared information: 92%
• 180 day full assessment: 92%

Overall Site Licence Application Statistics Summary

NHPD has received 1896 Site Licence Applications (SLAs) from January 1, 2004 to December 31, 2011. Of this total, 1851 (98%) SLAs have been completed, including the issuance of 1257 Site Licences. The remaining completed applications were either refused by NHPD or withdrawn by the applicant. A total of 2354 Site Licence Renewals have been received for issued Site Licences. 98% of all Site Licence Renewals have been completed.

During Quarter 3, NHPD received 32 SLAs and 57 Site Licence Renewals and completed 34 SLAs and 90 Site Licence Renewals.

Overall Clinical Trial Application Statistics Summary

From January 1, 2004 to December 31, 2011, NHPD has received 368 Clinical Trial Applications (CTAs). Of this total, 355 (96%) CTAs have been completed, including the issuance of 301 Notices of Authorization. The remaining completed applications were either refused by NHPD or withdrawn by the applicant. A total of 308 CTA Amendments and Notifications have been received for issued Notices of Authorization. 98% of all CTA Amendments and Notifications have been completed.

During Quarter 3, NHPD received 13 CTAs and 7 CTA Amendments and completed 14 CTAs and 4 CTA Amendments.

Quarter 3 (October 1, 2011 to December 31, 2011)

During this quarter, a total of 2230 PLAs were completed, 59% (1314) of these completions resulted in product licences, 32% (715) were refusals and the remaining 9% (201) of completions were as a result of the applicant withdrawing the application.

Of the 715 applications refused this quarter, the reasons were as follows:

• 69% failed to meet basic application requirements.
• 17% were refused when applicants did not respond to a request for further information.
• 6% were refused when quality, safety and/or efficacy issues were identified.
• 4% were refused when the applicant's response to a request for further information did not meet the requirements.
• 3% were refused for containing an ingredient not listed in the Natural Health Products Ingredient Database (NHPID).
• 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").
• 0% did not meet the definition of a NHP.

Unacceptable Applications

Since June 2009, certain applications are returned to applicants via regular mail if they are deemed to be unacceptable for processing, as referenced in section 7.2 of NHPD's Application Management Policy. These applications are accompanied by a Rejection Notice - Administrative Deficiency. NHPD reports on these applications by stating the total number of unacceptable application packages and the reasons for rejection.

During this quarter, a total of 130 product licence applications were deemed unacceptable and were not included in total product licence application statistics.

Of the 130 applications deemed unacceptable for processing this quarter, the reasons were as follows:

• 58% (75) incomplete PLA (pages were missing)
• 17% (22) missing attestation signature
• 13% (17) third party did not have authorization to sign on behalf of a company
• 9% (12) missing medicinal/non medicinal information (ie. ingredients were not submitted with application)
• 1.5% (2) missing the application type
• 0.75% (1) issue with ePLA
• 0.75% (1) contact information was not provided or incomplete

Quarter 3 Statistics (October 1, 2011 to December 31, 2011)

Chart 1 - Total Number of PLAs Received and Completed during Quarter 3 compared to Quarter 2

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

Chart 2 - Total Number of PLAs Completed during Quarter 3 compared to Quarter 2 (Licensed, Refused or Withdrawn)

Chart 3 - Total Number of PLAs Completed during Quarter 3, Pre vs. Post UPLAR (n=2230)

Chart 4 - Total Number of PLAs - by application type - Received and Completed during Quarter 3

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 3 compared to 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 3 compared to Quarter 2

Chart 7 - Total Number of Site Licence Applications (SLAs) Received and Completed during Quarter 3 compared to 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 3

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

Update on PLAs received before August 5, 2010 (pre-UPLAR)

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 2-5). 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 December 31, 2011 is 6,168. The objective is to complete the remaining 6,168 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 - PLAs Completed or In Progress	Number	% of Total (10,885)
Licensed	2356
In Licensing - administrative processing required	16
Refused	1535
To Be Refused - administrative processing required	16
Withdrawn by applicant	794
Total Completed	4717	43%
Full Assessment in progress	727
With Applicant pending response to IRN	836
Total Undergoing Full Assessment	1563	14%
In Queue for Full Assessment	2661
Total In Queue for Full Assessment	2661	25%
HaltedFootnote 1 pending internal decision related to safety or efficacy	1908
Miscellaneous Administrative Issues	36
Total Other	1944	18%

Chart 9 - Pre-UPLAR Applications Not Complete by Application Type (n=6168)

Chart 10 - Pre-UPLAR PLAs Not Complete: Ability to Sell (n=6135)

Update on PLAs received on or after August 5, 2010 (post-UPLAR)

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 require full assessment of safety, efficacy and / or quality 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: PLAs and Amendments completed in Quarter 3 that fully meet Pre-Cleared Information

Application Type	Completed	% Completed within 60 days
Compendial	728	92%
Labelling Standards	39	74%
Abbreviated Labelling Standards	11	45%
Amendments	177	98%
Total	955	92%

Of the 497 applications still in progress, 93% were received less than 60 days ago.

Applications requiring full assessment of safety, efficacy and / or quality 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. In some cases, the application may be withdrawn by the applicant during the 30 day period. The performance on these applications is outlined in Table 3 below.

This quarter, 1187 applications, which require full assessment of safety, efficacy and / or quality information, received an Application Acceptance Letter or decision. In 80% of cases, this was completed within the 30 day target.

Table 3: Breakdown of PLAs and Amendments for which an Application Acceptance Letter or decision was issued during Quarter 3

Action	Count	% Completed within 30 days
Application Acceptance Letter issued	865	81%
Notice of Refusal - Initial Assessment issued	313	75%
Withdrawn by the Company	9	100%

Chart 11 - Initial Assessment in Quarter 3: Acceptance versus Refusal (n=1178)

Of the 391 applications which have not yet received an Application Acceptance Letter or decision, 90% were received less than 30 days ago.

Applications which require full assessment of safety, efficacy and / or quality 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. This quarterly report provides more detail in regards to the 180 day timeline and the percentage of applications completed within that timeline.

This quarter, NHPD completed 557 applications requiring full assessment of safety, efficacy and / or quality. In 92% of cases, this was completed within the 180 day target.

Table 4: Breakdown of PLA and Amendments which require full assessment that were completed during Quarter 3

Action	Count	% Completed within 180 days
Product Licence Issued	424	93%
Notice of Refusal - Full Assessment	103	91%
Withdrawn by the Company	30	87%

Currently, there are 2054 applications which require full assessment that have been accepted and are currently in progress. 680 have exceeded 180 days. In 93% of cases (633 applications), this was as a result of a halted^{Footnote 1} issue.

Table 5 outlines the status of the 4984 PLA 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.

Table 5: Status of all PLA and Amendments received after August 5, 2010 which have received an Application Acceptance Letter

Status	Number	% of Total (4984)
Licensed	2052
In Licensing - administrative processing required	158
Refused	712
To Be Refused - administrative processing required	6
Withdrawn by applicant	166
Total Completed	3094	62%
Has received at least one request for further information	517
Full Assessment in progress	640
Total In Full Assessment	1157	23%
HaltedFootnote 1 pending internal decision related to safety or efficacy	733
Total Halted	733	15%

Chart 12 - Post-UPLAR PLAs not yet complete which have received an Application Acceptance Letter by Application Type (n=1890)

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 require full assessment of safety, efficacy and / or quality 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-UPLAR 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.