Status of Applications Quarterly Report

This content was archived on June 24, 2013.

Quarter 4 (January 1, 2011 to March 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 and site licence 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 Products Directorate.

Table of Contents

• Performance Summary and Highlights
• Quarter 4 (January 1, 2011 to March 31, 2011)
• Quarter 4 Statistics (January 1, 2011 to March 31, 2011)
  • Chart 1 - Total Number of PLAs Received and Completed during Quarter 4 compared to Quarter 3
  • Chart 2 - Total Number of PLAs Completed during Quarter 4 compared to Quarter 3 (Licensed, Refused or Withdrawn)
  • Chart 3 - Total Number of PLAs Completed during Quarter 4, Pre vs. Post UPLAR (n=2726)
  • Chart 4 - Total Number of PLAs - by application type -Received and Completed during Quarter 4
  • Chart 5 - Total Number of Product Licence (PL) Amendments Received and Completed during Quarter 4 compared to Quarter 3
  • Chart 6 - Total Number of Product Licence (PL) Notifications Received and Completed during Quarter 4 compared to Quarter 3
  • Chart 7 - Total Number of Site Licence Applications (SLAs) Received and Completed during Quarter 4 compared to Quarter 3
  • Chart 8 - Total Number of Site Licence (SL) Amendments, Notifications and Renewals Received and Completed during Quarter 4
• 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 = 7739)
  • Chart 10 - Pre-UPLAR PLAs Not Complete: Ability to Sell (n = 7739)
• Update on PLAs received on or after August 5, 2010 (post UPLAR)
  • Table 2: PLAs and Amendments completed in Quarter 4 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 4
  • Chart 11: Initial Assessment in Quarter 4: Acceptance versus Refusal
  • Table 4: Breakdown of PLAs and Amendments which require full assessment that were completed during Quarter 4
  • Table 5: Status of all PLAs and Ammendments 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 = 1160)
• 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 UPLAR came into force (pre-UPLAR PLAs), and
2. applications received after UPLAR came into force (post-UPLAR PLAs).

Overall Product Licence Application Statistics Summary

NHPD has received 59,790 PLAs from January 1, 2004 to March 31, 2011.  Of this total, 50,028 (84%) PLAs have been completed, including the issuance of 27,344 Product Licences representing 37,246 products. The remaining completed applications were either refused by NHPD or withdrawn by the applicant.  In total, 1396 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) which were not completed prior to that date, 28.9% have now been completed or are in the process of being completed.   NHPD is committed to completing the remaining 7739 applications before NHP-UPLAR is repealed in February 2013. 

Post-UPLAR Product Licence Application Statistics Summary

Of the 7,008 applications and amendments received on and after August 5th, 2010 (post-UPLAR PLAs), 48% fully meet NHPD's pre-cleared information and are subject to completion within 60 days of receipt.  The remaining 52% are subject to completion via the full assessment process within 180 days of being accepted by NHPD. 

During Quarter 4, NHPD met performance targets as follows:
30 day initial assessment: 97%
60 day pre-cleared information: 99%
180 day full assessment: 97%

Overall Site Licence Application Statistics Summary

NHPD has received 1781 Site Licence Applications (SLAs) from January 1, 2004 to March 31, 2011.  Of this total, 1707 (96%) SLAs have been completed, including the issuance of 1149 Site Licences.  The remaining completed applications were either refused by NHPD or withdrawn by the applicant.   A total of 2075 Site Licence Renewals have been received for issued Site Licences.  95% of all Site Licence Renewals have been completed.

During Quarter 4, NHPD received 70 SLAs and 125 Site Licence Renewals and completed 45 SLAs and 129 Site Licence Renewals.

Overall Clinical Trial Application Statistics Summary

From January 1, 2004 to March 31, 2011, NHPD has received 332 Clinical Trial Applications (CTAs).  Of this total, 306 (92%) CTAs have been completed, including the issuance of 263 Notices of Authorization.  The remaining completed applications were either refused by NHPD or withdrawn by the applicant.   A total of 265 CTA Amendments and Notifications have been received for issued Notices of Authorization.  91% of all CTA Amendments and Notifications have been completed.

During Quarter 4, NHPD received 10 CTAs and 7 CTA Amendments and completed 4 CTAs and 1 CTA Amendment.

Quarter 4 (January 1, 2011 to March 31, 2011)

During this quarter, a total of 2726 PLAs were completed, 52% (1425) of these completions resulted in product licences, 43% (1159) were refusals and the remaining 5% (142) of completions were as a result of the applicant withdrawing the application.

Of the 1159 applications refused this quarter, the reasons were as follows:

• 62% failed to meet basic application requirements.
• 17% were refused when applicants did not respond to a request for further information.
• 8% were refused for containing an ingredient not listed in the Natural Health Products Ingredient Database (NHPID).
• 6% were refused when the applicant's response to a request for further information did not meet the requirements.
• 6% were refused when quality, safety and/or efficacy issues were identified.
• 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").
• <1% 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.  Commencing with the previous quarterly report (Quarter 3, 2010-2011), NHPD now reports on these applications by stating the total number of unacceptable application packages and the reasons for rejection. 

During this quarter, a total of 120 packages were deemed unacceptable, this represented 163 product licence applications which were not included in total product licence application statistics as they are deemed incomplete applications.

Of the 120 packages deemed unacceptable for processing this quarter, the reasons were as follows:

• 30% missing signature
• 23% electronic application issue
• 17% third party did not have authorization to sign on behalf of a company
• 13% contact information was not provided or incomplete
• 8% no application type indicated
• 6% blank CD/DVD submitted
• 3% Transitional-DIN application received after December 31, 2009

Quarter 4 Statistics (January 1, 2011 to March 31, 2011)

Chart 1 - Total Number of PLAs Received and Completed during Quarter 4 compared to Quarter 3

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

Chart 2 - Total Number of PLAs Completed during Quarter 4 compared to Quarter 3 (Licensed, Refused or Withdrawn)

Chart 3 - Total Number of PLAs Completed during Quarter 4, Pre vs. Post UPLAR (n=2726)

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

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 4 compared to Quarter 3

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 4 compared to Quarter 3

Chart 7 - Total Number of Site Licence Applications (SLAs) Received and Completed during Quarter 4 compared to Quarter 3

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 4

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 March 31, 2011 is 7739.  The objective is to complete the remaining 7739 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	1528
In Licensing - administrative processing required	19
Refused	1126
To Be Refused - administrative processing required	59
Withdrawn by applicant	414
Total Completed	3146	28.9%
Full Assessment in progress	1068
With Applicant pending response to IRN	185
Total Undergoing Full Assessment	1253	11.5%
In Queue for Full Assessment	3484
Initial Assessment not yet completed	145
Total In Queue for Full Assessment	3629	36.6%
Halted1 pending internal decision related to safety or efficacy	2831
Miscellaneous Administrative Issues	26
Total Other	2857	26.2%

1 Halted applications include those containing enzymes, probiotics, energy drinks, nhps in food format, aromatherapy products and weight loss / weight management products.

Chart 9 - Pre-UPLAR Applications Not Complete by Application Type (n = 7739)

Chart 10 - Pre-UPLAR PLAs Not Complete: Ability to Sell (n = 7739)

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 4 that fully meet Pre-Cleared Information

Application Type	Completed	% Completed within 60 days
Compendial	1067	99%
Labelling Standards	148	100%
Abbreviated Labelling Standards	23	78%
Amendments	125	99%
Total	1363	99%

Of the 575 applications still in progress, 100% 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, 1472 applications, which require full assessment of safety, efficacy and / or quality information, received an Application Acceptance Letter or decision.  In 97% 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 4

Action	Count	% of Total (1895)
Application Acceptance Letter issued	1016	96%
Notice of Refusal - Initial Assessment issued	445	98%
Withdrawn by the Company	11	100%

Chart 11- Initial Assessment in Quarter 4: Acceptance versus Refusal

Of the 290 applications which have not yet received an Application Acceptance Letter or decision, 99% 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 709 applications requiring full assessment of safety, efficacy and / or quality.  In 97% of cases, this was completed within the 180 day target.

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

Action	Count	% Completed within 180 days
Product Licence Issued	463	96%
Notice of Refusal - Full Assessment	217	98%
Withdrawn by the Company	29	97%

Currently, there are 1160 applications which require full assessment that have been accepted and are currently in progress.  89 have exceeded 180 days, the breakdown is as follows:

• 12 (13%) remain in progress
• 77 (87%) are halted¹

Table 5 outlines the status of the 2168 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.

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

Status	Number	% of Total (1,163)
Licensed	597
In Licensing - administrative processing required	31
Refused	303
To Be Refused - administrative processing required	13
Withdrawn by applicant	64
Total Completed	1008	46.5%
Has received at least one request for further information	391
Full Assessment in progress	389
Total In Full Assessment	780	36.0%
Halted1 pending internal decision related to safety or efficacy	380
Total Other	380	17.5%

Chart 12 - Post-UPLAR PLAs not yet complete which have received an Application Acceptance Letter by Application Type (n = 1160)

1 Halted applications include those containing enzymes, probiotics, energy drinks, nhps in food format, aromatherapy products and weight loss / weight management products.

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

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-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.