Status of Applications Quarterly Report

This content was archived on June 24, 2013.

Quarter 3 (October 1, 2010 to December 31, 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*:

• 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 3 (October 1, 2010 to December 31, 2010)
• Quarter 3 Statistics (October 1, 2010 to December 31, 2010)
  • 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  • Chart 2 – Total Number of PLAs Completed during Quarter 3 compared to Quarter 2 (Licensed, Refused or Withdrawn)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 (by Year of Application)
  • 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 = 8169)
  • Chart 10 – Pre-UPLAR PLAs Not Complete: Ability to Sell (n = 8169)
  • 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-Unprocessed Product Licence Application Regulations Applications Not Complete which have received an Application Acceptance Letter by Application Type (n=880)
• Appendix A - Acronyms and Definitions

Performance Summary and Highlights

Format and content of report

The format of this NHPD Status of Applications Quarterly Report has not changed since the previous report (Quarter 2, 2010-2011) which was the first since 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.

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

Previous reports referred to the terms “backlog” and “regular workload”.  Commencing with the previous NHPD Status of Applications Quarterly Report (Quarter 2, 2010-2011), the terms "backlog" and "regular workload" are no longer used.  For more information on this change in terminology, please see the NHPD Status of Applications Quarterly Report (Quarter 2, 2010-2011).  

Commencing with this version of the Quarterly Report, NHPD has added one section regarding those product licence applications which are returned to applicants before processing begins.  This information can be found on page 5 of this report.

Overall Product Licence Application Statistics Summary

NHPD has received 57,246 PLAs from January 1, 2004 to December 31, 2010.  Of this total, 47,302 (83%) PLAs have been completed, including the issuance of 25,919 Product Licences representing 34,961 products. The remaining completed applications were either refused by NHPD or withdrawn by the applicant.  In total, 1326 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, 25% have now been completed or are in the process of being completed.   NHPD is committed to completing the remaining 8169 applications before NHP-UPLAR is repealed in February 2013.

Post-UPLAR Product Licence Application Statistics Summary

Of the 4,194 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.

Overall Site Licence Application Statistics Summary

NHPD has received 1711 Site Licence Applications (SLAs) from January 1, 2004 to December 31, 2010.  Of this total, 1662 (97%) SLAs have been completed, including the issuance of 1119 Site Licences.  The remaining completed applications were either refused by NHPD or withdrawn by the applicant.   A total of 1950 Site Licence Renewals have been received for issued Site Licences.  95% of all Site Licence Renewals have been completed. 

Overall Clinical Trial Application Statistics Summary

From January 1, 2004 to December 31, 2010, NHPD has received 322 Clinical Trial Applications (CTAs).  Of this total, 302 (94%) CTAs have been completed, including the issuance of 259 Notices of Authorization.  The remaining completed applications were either refused by NHPD or withdrawn by the applicant.   A total of 249 CTA Amendments and Notifications have been received for issued Notices of Authorization.  98% of all CTA Amendments and Notifications have been completed.

Quarter 3 (October 1, 2010 to December 31, 2010)

During this quarter, a total of 3017 PLAs were completed, 49% (1477) of these completions resulted in product licences, 46% (13787) were refusals and the remaining 5% (162) of completions were as a result of the applicant withdrawing the application.

Of the 1378 applications refused this quarter, the reasons were as follows:

• 45% failed to meet basic application requirements.
• 21% were refused when applicants did not respond to a request for further information.
• 18% were refused when the applicant’s response to a request for further information did not meet the requirements.
• 10% were refused for containing an ingredient not listed in the Natural Health Products Ingredient Database NHPID).
• 5% 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 this report, NHPD will report on these applications by stating the total number of unacceptable application packages and the reasons for rejection.  During this quarter, a total of 105 packages were deemed unacceptable, this represented 175 product licence applications which are not included in total product licence application statistics as they are deemed incomplete applications. 

Of the 105 packages deemed unacceptable for processing this quarter, the reasons were as follows:

• 34% missing signature
• 28% third party did not have authorization to sign on behalf of a company
• 18% contact information was not provided or incomplete
• 13% electronic application issue
• 3% no application type indicated

Quarter 3 Statistics (October 1, 2010 to December 31, 2010)

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 (by Year of Application)

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 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 December 31, 2010 is 8169. The objective is to complete the remaining 8169 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	1284
In Licensing – administrative processing required	14
Refused	992
To Be Refused - administrative processing required	110
Withdrawn by applicant	316
Total Completed	2716	25.0%
Full Assessment in progress	1312
With Applicant pending response to IRN	192
Total Undergoing Full Assessment	1504	13.8%
In Queue for Full Assessment	3724
Initial Assessment not yet completed	265
Total In Queue for Full Assessment	3989	36.6%
Halted1 pending internal decision related to safety or efficacy	2646
Miscellaneous Administrative Issues	30
Total Other	2676	24.6%

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 = 8169)

Chart 10 – Pre-UPLAR PLAs Not Complete: Ability to Sell (n = 8169)

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 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	1550	1065	98%	485
Labelling Standards	270	208	92%	62
Abbreviated Labelling Standards	38	21	67%	17
Amendments	150	145	99%	5
Total	2008	1439	97% (average)	569

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. The performance on these applications is outlined in Table 3 below.

Of the 2186 applications received on or after August 5, 2010 which require full assessment of safety, efficacy and / or quality information, 1895 (84%) have received an Application Acceptance Letter or decision. In 96% of cases, this was completed within the 30 day target.

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

Action	Count	% of Total (1895)
Application Acceptance Letter issued	1163	61%
Pending Notice of Refusal – Initial Assessment	51	3%
Notice of Refusal – Initial Assessment issued	658	35%
Withdrawn by the Company	23	1%

Of the 291 applications which have not yet received an Application Acceptance Letter or decision, 93% were received less than 30 days ago and thus, are currently undergoing Administrative processing or Initial Assessment by NHPD.

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. 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 149 days of performance monitoring at NHPD (August 5 – December 31).

Table 4 outlines the status of the 1163 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.

Status	Number	% of Total (1,163)
Licensed	139
In Licensing – administrative processing required	13
Refused	86
To Be Refused - administrative processing required	11
Withdrawn by applicant	34
Total Completed	283	24.3%
Has received at least one request for further information	448
Full Assessment in progress	240
Total In Full Assessment	688	59.2%
Halted1 pending internal decision related to safety or efficacy	2646
Total Other	192	16.5%

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

Chart 11- Post-Unprocessed Product Licence Application Regulations Applications Not Complete which have received an Application Acceptance Letter by Application Type (n=880)

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.