2009-12-23
Charting A Course: Refining Canada's
Approach to Regulating Natural Health
Products
Document Objective
This document has been developed as a tool to introduce issues and stimulate discussion
around the Natural Health Products Regulatory Review (the Review). It is intended to
provide the reader with sufficient background and information to understand the context
of proposed components of the review. This document is meant to support the initial
stages of the discussion.
For additional information and/or copies of the document please contact:
Natural Health Products Directorate
Health Products and Food Branch
Address Locator: 3302A
Tel: 1-888-774-5555
Fax: (613) 948-6810
E-mail:
ISBN: H164-41/2007E-PDF
978-0-662-45385-7
This document is also available on our Web site at the following address:
http://www.healthcanada.gc.ca/hpfb-blueprint
3
TABLE OF CONTENTS
FOREWORD..................................................................................................................... 4
CHAPTER 1 - Setting the Stage ...................................................................................... 5
Part 1 – Introduction .................................................................................................... 5
Broader Context for the NHPR Review...................................................................... 5
Part 2 - Where We Came From: The Regulation of NHPs in Canada .................... 6
Part 3 - Where We Are Now: The Present Regulatory Framework for NHPs..... 10
Part 4 -Where Are We Going: Identifying and Addressing the Challenges ......... 12
CHAPTER 2 – NHPD Business Improvement Initiatives........................................... 14
Part 1- Regulation and Sale of NHPs in Canada ..................................................... 14
Part 2 - Addressing the Operational Challenges...................................................... 14
Part 3 - Improvement Efforts .................................................................................... 15
Part 4 - Positive Results thus Far................................................................................ 16
Part 5 - Next Steps........................................................................................................ 16
Part 6 - Conclusions..................................................................................................... 17
CHAPTER 3 – The Natural Health Products Regulatory Review............................. 18
Part 1 – Review Objectives, Challenges and Guiding Principles ........................... 18
Part 2 – Why is it Time for a Regulatory Review? .................................................. 19
Part 3 – What do We Want to Be? ............................................................................ 20
Part 4 – Background to the Natural Health Products Regulations (NHPR)........... 21
Part 5 – Approach to the Review............................................................................... 22
Issues Identified to Date for the Review.................................................................. 23
Part 6 - What we are Asking from Stakeholders ..................................................... 26
CHAPTER 4 – Short Term Action Plan....................................................................... 28
Natural Health Product Regulatory Review – Short-Term (0 – 9 months) Key
Activities and Timeframes ......................................................................................... 29
Appendix A...................................................................................................................... 33
Appendix B ...................................................................................................................... 41
Appendix C...................................................................................................................... 42
Appendix D...................................................................................................................... 43
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FOREWORD
This document provides background information on the Natural Health Products Regulations
(NHPR) and the Natural Health Products Regulatory Review Initiative (the Review) for the
purposes of stakeholder consultation. The Review is intended to guide the process for the
refinement of the regulation of natural health products in Canada.
The purpose of this first step in the process is to provide stakeholders with an opportunity
to familiarize themselves with the Review and regulatory policy issues that Health
Canada proposes to address in the context of this Review..
This document consists of four chapters: Chapter 1 is intended to contextualize both the
operational and the regulatory aspects of the NHPR. Chapter 2 describes certain
operational improvements which are currently underway. Chapter 3 describes the
Review process and those issues which have currently been identified for review. These
issues are further elaborated in Appendices A-D at the end of this document. In Chapter 4
can be found an action plan that describes how we are going to deal with policy and
regulatory initiatives which Health Products and Food Branch (HPFB) is undertaking in
the short term.
The issues that are listed and described in this document (Chapters 3 and 4 and in
Appendices A-E), represent an inventory of regulatory policy issues which have been
identified over the three years since implementation of the NHPR, through both
experience and from feedback received from stakeholders.
An online questionnaire will supplement this document to facilitate specific feedback
from stakeholders on a listing of issues. The NHPD encourages stakeholders to review
this document and provide feedback using this questionnaire, which will be available on
the Health Canada website on March 23, 2007. Notification will be sent to stakeholders
announcing the availability of this consultation questionnaire.
Because of the regulatory nature of the identified issues, this paper may be of special
interest to people in industry, health care practice, academia, non-governmental
organization (NGOs), provincial and territorial governments and regulatory bodies, as
well as consumers who use NHPs. The feedback received will assist in the development
of options and planning for issues resolution.
This document should be read in conjunction with the accompanying Notice to
Stakeholders and the relevant sections of the NHPR (http://www.hc-sc.gc.ca/dhpmps/
prodnatur/legislation/acts-lois/index_e.html).
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CHAPTER 1 - Setting the Stage
The Context and Background for Refinement of the
Natural Health Products Regulatory Regime
Part 1 – Introduction
The regulatory framework for natural health products (NHPs), the Natural Health
Products Regulation (NHPR), came into force January 1, 2004, following extensive
legislative and consultative processes. The NHPR were a direct response to an expressed
need for specific regulatory oversight of NHPs in Canada.
At the time that the regulations came into force, a commitment was made to undertake a review
of the regulations within the first three to five years of their implementation. This review has
been launched further to that commitment and in consideration of challenges and issues which
have been identified in the first three years of regulating NHPs.
These challenges largely flow from one of three sources, operational practices at Natural Health
Products Directorate (NHPD) relating to issuing product licences, the interpretation and
implementation of compliance and enforcement activities and the regulations themselves. This
review will focus on those challenges which flow directly from the regulations. In tandem with
this review, operational challenges are being addressed by ongoing business improvement
initiatives and compliance and enforcement practices are being refined to best serve the needs of
Canadians. (See Chapter 2).
Broader Context for the NHPR Review
The Natural Health Products Regulatory Review (the Review) is being undertaken as part
of the Health Products and Food Branch's (HPFB) Blueprint for Renewal initiative,
which aims at modernizing the regulatory system for all health products and food
regulated by Health Canada. A number of objectives and initiatives being advanced
under the Blueprint umbrella will help inform the action plan to improve the regulatory
framework for NHPs. For example, the following Blueprint initiatives will be closely
aligned to the Review:
�� Strategies to ensure that regulatory interventions are proportional to risk within
and across the various regulatory frameworks covering health products and food -
for example, Health Canada will consider pursuing administrative or policy
approaches to regulate certain low-risk products currently covered under the
NHPR, such as personal care products.
�� Regulatory modernization strategy for food - potential implications for products
that are at the border of the NHP and food regulatory frameworks.
�� Strengthening safety oversight through the adoption of life cycle approaches to
the regulation of pharmaceuticals and biologics (progressive licensing project) -
elements of this model could be considered in the context of NHPs.
6
The HPFB has released a discussion paper on the Blueprint for Renewal plan.
Consultations were held from October to December 2006 on this Blueprint plan. Reports
from these consultations, as well as the discussion paper, are posted on the Blueprint web
site at: http://www.healthcanada.gc.ca/hpfb-blueprint .
Complementary activities to the Blueprint for Renewal initiative include a Branch-wide
resource review exercise aimed at ensuring that HPFB has adequate capacity and
resources to deliver on its mandated activities, as well as the development of a new
external charging regime for the various regulatory activities of the Branch. The specific
needs of the NHP program will be considered as part of these exercises.
Part 2 - Where We Came From: The Regulation of NHPs in Canada
2.1 Why Regulate NHPs?
A recent survey shows that 71% of Canadians regularly take vitamins and minerals,
herbal products, homeopathic medicines and other products that are now regulated as
NHPs. (Baseline Natural Health Products Survey Among Consumers (2005) online at
http://www.hc-sc.gc.ca/dhp-mps/pubs/natur/eng_cons_survey_e.html). Of those
surveyed, 38% indicated that they took NHPs daily and a further 38% indicated that they
took NHPs daily during certain seasons of the year. The most commonly used types of
NHPs were vitamins (57%), Echinacea (15%), herbal remedies and fungal products
(11%), Glucosamine (8%), homeopathic medicines (5%), natural organic products (5%)
and supplements (5%).
The breadth and variety of these products is immense. It is estimated that some 40,000
products currently on the Canadian market can be classified as NHPs. At the same time,
Canadians are taking more responsibility for their own health and, in many cases, this has
led to an increased awareness of, and demand for, NHPs. The most often cited reasons for
using NHPs include being generally concerned about their health, that they help maintain
and promote health , and a belief that they are better for personal health than chemical
products/drugs.
NHPs will often be taken to complement conventional medical treatments or address a
gap in such treatments. Many of these products have roots in cultural practices and form
part of the rich cultural heritage of Canadians. Keeping this in mind, and with so many
products falling within the definition of an NHP, it is essential to ensure their safety,
efficacy and the accuracy of any health claims that are made concerning their use.
There is a common misconception that all NHPs are 'natural' and therefore safe. In
reality the safety of NHPs depends upon the amount or dosage, the characteristics of the
user and the context in which they are used. Indirect harm may occur when you
inappropriately ignore more proven or appropriate care (either complementary or
conventional) by taking an NHP. Direct harm may occur because the body's organ
systems and metabolic processes are complex and interactive and any health product is
likely to have side effects. Harm may even occur when taking an NHP as directed, where
other factors overlap to make the NHP use dangerous. Effective oversight of the
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conditions of use, real world safety and communication between consumers, NHP
providers and government is critical in ensuring consumer safety.
2.2 The Evolution of the NHPR
While the debate about regulating NHPs has been going on for some time, the inception of
the NHPR began in 1997 with an announcement by the Minister of Health of a full public review by the House of Commons Standing Committee on Health (SCOH) of the legal regime governing NHPs in Canada. The SCOH initiated broad consultations to seek input from industry, health care practitioners and consumers regarding a regulatory framework for NHPs. The objective of this consultation was to ensure a balance between Canadians' freedom of choice with respect to NHPs and the assurance of consumer safety.
During these consultations, stakeholders consistently requested a specific regulatory framework for NHPs that would provide Canadians with access to safe, effective and high quality NHPs, and regulate NHPs in a manner commensurate with their level of risk.
In 1998, the Standing Committee tabled in the House of Commons its report called Natural Health Products: A New Vision, The Standing Committee report included 53 recommendations which formed the basis of the new regulatory structure for NHPs.
Copies of the report are available at
http://www.hc-sc.gc.ca/ahc-asc/media/nrcp/2000/2000_51bk3_e.html.
In 1999, the Minister of Health announced the creation of the Office of Natural Health Products, now the NHPD, with a mandate to implement the Standing Committee recommendations. (See NHPD: Progress on the 53 Recommendation of the Standing Committee on Health at http://www.hc-sc.gc.ca/dhp-mps/prodnatur/aboutapropos/53_recommend_nhp-cps_tc-tm_e.html).
In March 2001, the NHPD initiated consultations with representatives from industry, consumer groups, health care practitioners, academics and government and regulatory bodies, and subsequently drafted and released the proposed regulatory framework. Based on stakeholder feedback, and in keeping with the Standing Committee recommendations, the proposed regulatory framework was developed. The proposed regulations were pre-Key Milestones in the Development of the NHPR
October 1997 – Minister of Health announces full public review by SCOH of legal regime governing NHPs.
May 1998 – SCOH tables recommendations for a new regulatory regime governing NHPs.
March 1999 – The government accepts all 53 recommendations and creates the Office of Natural Health Products, now NHPD.
June 1999 – May 2000 – Transition team consults and submits report on best way to meet SCOH 53 recommendations.
June – September 2000 – NHPD consults with stakeholders on best way to implement NHP regulatory regime.
September 2001 – Draft of Proposed regulations shared with stakeholders.
December 2001 – NHPR pre-published in Canada Gazette Part I.
June 2003 – NHPR pre-published in Canada Gazette Part II.
January 2004 – NHPR came into force with a transitional period for various products.
8 published in the Canada Gazette, Part I (CGI), on December 22, 2001. Over 600 comments were received during the CGI comment period. Following analysis and revisions based on this input, the proposed regulations were published in the Canada Gazette, Part II on June 18, 2003 and came into force, as noted above, on January 1,2004.
2.3 Transition Period
With the coming into force of the NHPR, nearly 40,000 products required review prior to
issuing market authorization as an NHP. Some of these products had previously been
issued Drug Identification Numbers (DINs) under the Food and Drug Regulations
(FDR), some were dealt with as non-compliant foods, while others had not previously
been subject to any Canadian regulatory requirements. The NHPR provided transition
provisions for both products and sites.
The NHPR set out a two-year transition period for site licensing beginning on January 1,
2004. Manufacturers, packagers, labelers and importers of NHPs conducting those
activities in Canada before the coming into force of the NHPR were permitted to continue
doing so in accordance with their establishment licence issued under the FDR until
December 31, 2005. The NHPR also contain a six-year transition period for product
licensing, from January 1, 2004 to December 31, 2009, with respect to the packaging and
sale of NHPs with DINs.
The applicable provisions of the FDR continue to apply for products with a DIN until they are
licensed under the NHPR.
These transition guidelines were developed according to the risks associated with a product and the type of evidence needed to assess a product licensing application (i.e. novel products would be
assessed before traditional medicines).
As of January 1, 2004, all new products (i.e. products not previously on the market) that meet the NHP definition had to comply with the NHPR and with the full licence application process in order to be sold in Canada.
The Health Protection and Food Branch (HPFB), including NHPD and the Inspectorate,
put into effect a Compliance Policy which established a process for priority approval of NHPs based on potential risks, while re-enforcing Health Canada's ability to take immediate compliance and enforcement action on any product which poses a risk to the health and safety of Canadians. (The Priority Approach to Compliance and Enforcement is presented in the accompanying table, see Natural Health Products Compliance Guide Transitional Provisions
Jan 1
2004
Jan 1
2006
Jan 1
2008
Jan 1
2010
Phased in transition for Product License, Site License and GMP Compliance
NHP with DIN (NHP Reg / Food & Drug Reg)
NHP without DIN (Target & not NHP Reg)
SITE LICENCE (NHP Reg)
New NHP
New Site
(Introduced after Dec 31, 2003)
9
online at http://www.hcsc.
gc.ca/dhpmps/
prodnatur/legislation/pol
/compli-conform/complianconform_
guide_e.html).
Focusing initial licencing
efforts on those NHPs which
pose the greatest potential
harm ensures that Health
Canada works efficiently
towards its mandate. NHPD
continues to strive to meet
the deadlines established in
the Compliance Policy.
(More information on the
assessment and licensing
activities of the NHPD in included in Chapter 2.)
2.4 International Regulation of NHPs
The international trend is towards the development of regulations specific to NHPs. The
Canadian framework is often cited as a model for good management and law making
being considered innovative and forward thinking. While other jurisdictions are still in
the early stages of exploring how best to classify these products and ensure appropriate
regulatory oversight, the Government of Canada has taken decisive steps to ensure that
they are assessed for safety and efficacy.
Many countries lack regulations specific to NHPs as a unique class of therapeutic
products. For those countries that do regulate these products, there are vast differences in
the definition and categorization of those products which, in Canada, would be
considered NHPs with some considering them to be a subset of drugs and some as a
subset of foods. For example, while in the United States the vast majority of NHPs are
considered as foods (dietary supplements), in certain countries in Europe, herbal
medicines are regulated under the drug regulations with vitamins and minerals considered
as foods. In other countries, such as Singapore, certain subsets of NHPs (Chinese
Proprietary Medicines) are regulated in a very controlled manner with no specific
regulations existing for the other types of NHPs on the market. The regulatory situation
in each country also impacts which type and extent of claim is permissible. These
differences in definition and categorization result in inconsistencies in the approaches to
assessing and mitigating risk and thereby creating challenges for both Health Canada and
for some stakeholders (e.g., the exportation of NHPs from Canada to countries which
categorize NHPs as drugs).
Several countries and the World Health Organization (WHO) have recognized the
comprehensive and innovative nature of the NHPR and Health Canada's leadership in the
regulation of NHPs. They monitor our progress closely. Other jurisdictions are looking
to the Canadian model to help ensure the safety of products which do not fall under the
conventional definition of either a food or a drug, but are commonly used for medicinal
Priority Approach to Compliance and
Enforcement
Priority 1 - NHP substances in the TPD's New Drug List
Priority 2 - Isolates, amino acids, fatty acids, and
concentrated volatile ( essential ) oils
Priority 3 - Algal, bacterial, fungal, probiotics and
non-human animal materials
Priority 4 – Plants, plant materials, extracts and
volatile (essential) oils
Priority 5 - Vitamins and Minerals
Priority 6 - Homeopathic Medicines
June 1, 2004
Jan 1, 2005
June 1, 2005
June 1, 2007
Jan 1, 2008
June 1, 2008
10
purposes. Canada is currently acting as Secretariat for the new network for International
Regulatory Cooperation on Herbal Medicines, a WHO-facilitated initiative.
Part 3 - Where We Are Now: The Present Regulatory Framework for NHPs
3.1 At a Glance: A Regulatory Framework for Natural Health Products
The NHPR include provisions on: definitions, product licensing, site licensing, good
manufacturing practices, clinical trials, labelling and packaging requirements, and
adverse reaction reporting. (These various provisions will be dealt with in greater detail
in Chapter 3).
�� The definitions include the definition of a natural health product and other terms
which are key to the functioning of the NHPR. Products that fall within the NHPR
include herbal remedies, homeopathic medicines, vitamins, minerals, traditional
medicines, probiotics, amino acids and essential fatty acids.
�� A product licensing system requires that all licensed products display an 8-digit
product identification number preceded by the prefix NPN, or, in the case of a
homeopathic medicine, by the letters DIN-HM on their labels.
�� A system of site licensing requires that all manufacturers, packagers, labellers,
and importers be licensed.
�� Good Manufacturing Practices (GMPs) are required to ensure product safety
and quality, and linked to issuance of a site license.
�� Clinical Trial Procedures identify those practices which are required for
researchers conducting NHP experimental trials involving human subjects.
�� Standard labelling requirements are established to ensure consumers can make
informed choices.
�� An adverse reaction reporting system for NHPs assists Health Canada in
identifying previously unrecognized, rare, or serious adverse reactions, and
imparting health product safety knowledge that benefits all Canadians.
The NHPR also incorporate by reference a number of provisions from FDR. Some of
these are critical for the compliance and enforcement of the NHPR.
3.2 Re-Affirming the Worth of the NHPR
Following the 2005 Standing Committee on Health (SCOH) hearings on Bill C-420, the
value of the current regulatory framework was re-affirmed. In its 2004 report on Bill C-
420, the SCOH found that:
11
The regulations ensure safety through an appropriate level of oversight,
permit a full range of evidence-based health claims, and ensure high quality
through outcome-based good manufacturing practices.
The SCOH also reiterated that:
The regulations were developed following extensive consultations and thus
reflect the desire of Canadians for a regulatory framework appropriate to
the level of risk associated with natural health products.
3.3 The Licensing Process
Generally, NHPD applies a similar process to managing product licensing applications, site
licensing applications and clinical trial applications. Assessment of new applications occurs in a
four stage process:
Step 1 Verification – An NHP application file is created and receipt of the
application is acknowledged.
Step 2 Processing – The NHP file is reviewed for completeness or basic errors. If
the file is incomplete, it will not be processed. If it is found to be complete, it will
be presented for assessment.
Step 3 Assessment - The application submissions are evaluated, first for the
completeness of supporting documentation and then for any missing information.
Applications are reviewed and an assessment report is generated based on the
evidence provided. Assessment reports are then reviewed and a final
recommendation for approval or refusal of the application is made.
Step 4 Decision – The NHPD confirms and formally issues the decision to
applicants.
3.4 Assessment Proportional to Risk
In assessing the health and safety risks of NHPs a 'one size fits all model' cannot easily
be applied. In reviewing the information provided by applicants, the totality of all
evidence submitted with the application must be reviewed. Based on the potential risks
stemming from particular products, and/or claim(s) being made, a varying continuum of
evidential standards needs to be met.
A rigorous and comprehensive review of this data is essential to ensure the health and
safety of Canadians and justifying the availability of an NHP in the marketplace. The
strength and volume of the presented evidence, the credibility of the sources cited, quality
of publications provided, and the overall utility of this data for demonstrating the safety
and efficacy of the NHP are all assessed and reviewed in order to reach the final
recommendation at Stage 3 'Assessment'.
12
Keeping these points in mind, Health Canada has established an evidence evaluation
framework based on categories developed by the United States Agency for Healthcare
Research and Quality, and adopted with minor modifications by the WHO, for product
evaluations. An important feature of this approach is the recognition that a gradient of
evidence can be used to support the claims of safety and effectiveness in a product
licensing application.
The risk classification scheme is an evidence-based approach that classifies a product into a level of
risk based on relevant information from published and unpublished sources, such as, but not limited to, peer- reviewed or professional journals, textbooks, reports from other regulatory bodies, etc. The evidence will primarily be from experience of the product or ingredient's use by humans, but may also include relevant information, when necessary, from animal studies.
The balance of evidence must support safety and efficacy in such a way that the benefits of allowing the NHP on the market outweigh the risks of doing so. Applicants are expected to provide a summary of all relevant evidence, both favorable and unfavorable.
Part 4 -Where Are We Going: Identifying and Addressing the Challenges
4.1 Lessons Learned in the First Three Years of Regulating NHPs
As part of Health Canada's on-going efforts to consult with Canadians on its regulatory frameworks, the NHPD meets regularly with key stakeholders and its advisory committees (Expert Advisory Committee http://www.hc-sc.gc.ca/dhpmps/prodnatur/activit/com/expert/index_e.html and Management Advisory Committee http://www.hc-sc.gc.ca/dhp-mps/prodnatur/activit/com/mgmt-gest/index_e.html). By
meeting with these Committees of representative stakeholders and by listening to additional stakeholders, NHPD has gathered input regarding the functioning of the current regulatory regime under the NHPR. The challenges and issues which have arisen during the first three years of the implementation of the NHPR point to three aspects: (1) operational/licensing (2) regulatory & policy and (3) compliance and enforcement.
While the focus of this paper is on regulatory review, in response to the operational challenges that the Health Products and Food Branch face related to compliance and enforcement, the Branch has outlined issues of capacity as a priority, and has committed to providing support to address this issue in the upcoming fiscal year.
Risk Based Continuum: Standards of Evidence International standard: similar to
U.S. AHRQ (DHHS) and Australian TGA models.
Level II – Well-designed clinical trials without randomization and/or control groups
Level III – Well-designed descriptive and observational studies, such as correlational studies, cohort studies, case-control studies
Level IV – Peer-reviewed published articles, pharmacopoeias, conclusions of other reputable
regulatory agencies, previous marketing experience, and expert opinion reports
Level V – References to traditional uses (at least 50 consecutive years of use)
EVIDENCE
PYRAMID
Level I - Well designed systematic reviews and metaanalyses of randomized
controlled trials or other clinical trials, or at least one welldesigned randomized controlled
trial (preferably multi-centred)
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For example, the Inspectorate has extended its interim policy, which allows NHP
companies to make use of the Certificate of Pharmaceutical Product (CPP) program. The
CPP program is an internationally recognized WHO document that attests to a product
meeting domestic regulatory requirements, and is a prerequisite to have a product
imported in many jurisdictions.
In responding to the specific operational issues which have been identified for the
Review, efforts have been made to increase operational efficiencies, outlined in more
detail in Chapter 2.
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CHAPTER 2 – NHPD Business Improvement Initiatives Part 1- Regulation and Sale of NHPs in Canada
As outlined in Chapter 1, the Natural Health Products Regulations (NHPR) came into
force on January 1, 2004 following a comprehensive and extensive, multi-sectoral, multiyear
consultative process. Under this new regulatory framework, all NHPs must be
licenced before they can legally be sold in Canada. Product licences are authorized
following a pre-market review and assessment for safety, efficacy and quality conducted
by Health Canada. In addition to product licensing, Canadian firms involved in the
manufacture, packaging, labeling and/or importation of NHP for commercial sale must
have valid site licenses which are obtained by demonstrating that they follow appropriate
good manufacturing practices (GMPs).
As with all novel approaches, implementing this ambitious and comprehensive regulatory
agenda has not come without its challenges. This is not surprising given the volume,
variety and complexity of the products available on the market as well as a developing
NHP industry that, for the most part, has not been subject to systematic health regulation.
Part 2 - Addressing the Operational Challenges
As a result, of these initial implementation challenges, Health Canada accumulated a
processing delay of several thousand product licence applications within its first three
years of operation. Of the estimated 42,000 products currently on the market,
approximately 12,400 have been authorized for sale (2,411 since January 1, 2004 and
10,000 as drugs prior to that). Since January 1, 2004, the Department has received a total
of 18,017 product and site licence applications and has fully processed 7,003 (either
licensed or refused the application due to lack of information or safety concerns).
Acknowledging the situation it found itself in, NHPD launched, in the summer of 2005,
its Business Improvement Initiative (BII). Objectives of this initiative are to eliminate
the processing delay, streamline the application review process to avoid future delays,
and increase operational capacity to permit issuance of 60 product licenses and 12 site
licenses per day.
Despite the limited regulatory experience in other jurisdictions, Health Canada
nevertheless recognizes the importance of international work in addressing current
challenges. For example, use of more international standards to support the
implementation of the NHPR, when feasible, such as, adoption of the Chinese
Pharmacopeia (Canada is the first country outside of Asia to do so), adopting the
Australian Therapeutic Goods Administration (TGA) approved terminology for naming
medicinal ingredients as per their Electronic Listing Facility system, adopting
International Conference on the Harmonization (ICH) -M5 Controlled Vocabulary for
Dosage forms, adopting Medical Dictionary for Regulatory Activities (MedDRA)
medical terminologies for indications and warnings, accepting GMP certificates from
international mutual recognition agreements (MRA) and Pharmaceutical Inspection
Cooperation Scheme (PIC/S) partner countries and using WHO Monographs.
15
Part 3 - Improvement Efforts
A first step in the BII was to conduct an in-depth analysis of operating resources and
processes to identify strengths and opportunities for improvement. Following this
analysis, an action plan was put in place which targets system processes, standard
operating procedures and human resources. These BII measures are being progressively
phased in and include, specifically:
3.1. Process Reengineering:
- development of Standard Operating Procedures and process adjustments including:
regular, ongoing training for Assessment Officers to ensure consistency, changes to
evidence requirements to streamline reviews and reduce review time, and refusal of
applications that do not meet minimum screening criteria (eg., for completeness);
- development and ongoing revision of Guidance Documents to ensure clarity,
coherence and up-to-date information (see http://www.hc-sc.gc.ca/dhpmps/
prodnatur/legislation/docs/index_e.html);
- compendial-like assessment for new types of applications, homeopathic medicines,
traditional – pharmacopoeial, food-like NHPs, transitional DINs, etc.;
- development of regulatory focused NHP monographs as tools to increase the
number of applications that can be assessed through the compendial stream;
- completion of Category IV Monographs, labeling standards and a monograph
policy for multi-ingredient products (e.g., multi-vitamin, multi-mineral);
- focused processing initiatives by product categories (e.g., homeopathic medicine
focus); and,
- batch reviews by ingredient and company to increase efficiency and minimize
review time via repetitive processing (e.g., Glucosamine and Chondroitin products).
3.2. Human Resource (HR) Capacity:
- increasing HR capacity and shifting role and responsibility areas, including shifting
administrative tasks to free scientists to concentrate on assessment activities and
reallocating resources to priority areas such as monograph development.
3.3 System Development:
- implementation of an online information system - to support the NHP licensing
program - for filing and processing submissions under the NHPR. The solution will
maintain a database of pre-qualified acceptable known NHP ingredients as well as
manage the submission and handling of license applications through the entire
lifecycle. This solution will also:
- collapse processing delays and work effort related to errors and/or omissions in
applications;
- reduce manual entry by enabling electronic submission of applications; and
16
- development of a world-class ingredient database that is the first of its kind, which
will greatly enhance future productivity when posted and will be subsequently
integrated into the Online System. The aim of this database is to consolidate all
approved ingredient related information (medicinal and non-medicinal) specific to
NHPD. 'Stage 1' (non-medicinal ingredients, and classified medicinal ingredients)
is now complete, with 4,000 ingredients now available. The system has been
recommended for production by our technical authorities and is available internally
at Health Canada as of late January 2007.
Part 4 - Positive Results thus Far Since the coming into force of the regulations in January 2004, the
NHPD has addressed operational challenges related to implementing the new regulatory framework through ongoing adjustments. The BII was designed to build on results achieved during this initial implementation period. Since the launch of the BII in late 2005, a number of positive results
have been achieved, including:
- decisions on licence applications are being made 6 times faster than in 2005 prior to the launch of the BII, representing a 400% decrease in the time it takes for decisions;
- Health Canada is now actively assessing an average 40 licence applications per day;
- 40% of the applications received are complete in site licensing,
product licence acknowledgment and screening, and compendial product licence application
assessment; and - The majority of clinical trials have been assessed
- assessment of site licence applications is meeting the day service standard.
Part 5 - Next Steps
The NHPD has made significant progress since the Summer 2005 implementation of the
BII. That being said, a sizeable number of product licence applications remain
unprocessed and improvement efforts are ongoing that will focus on this last area of
processing delay. Key to this will be the launch within the next fiscal year of the on-line
product assessment system, which will allow for a fully automated and speedier review of
Product Application Decisions Made by NHPD
0
1000
2000
3000
4000
5000
6000
7000
Oct-05
Nov-05
Dec-05
Jan-06
Feb-06
Mar-06
Apr-06
May-06
Jun-06
Jul-06
Aug-06
Sep-06
Oct-06
Nov-06
Dec-06
Decisions Made Product Application Decision Status
*As of Jan. 2, 2007
*6400
Site Application Decision Status
*666
For the month end.
* As of Feb. 23, 2007
0
100
200
300
400
500
600
700
Nov-05
Dec-05
Jan-06
Feb-06
Mar-06
Apr-06
May-06
Jun-06
Jul-06
Aug-06
Sep-06
Oct-06
Nov-06
Dec-06
Jan-07
Decisions Made incoming licence applications. This new tool will also go a long way in facilitating
industry's ability to submit complete and high quality product and site licence
applications. If the achievements of the past year and a half serve as any indication,
Health Canada will be able to reach its goal of processing the majority of the remaining
processing delays within the new fiscal year. Health Canada will continue to work with
international partners on systems development issues, in particular with Australia which
has implemented its very successful "Electronic Listing Facility" system for all listed
complementary medicines.
The Review occurring in tandem with the BII, as outlined in Chapter 3, is designed to
address regulatory issues which have been identified since the coming into force of the
NHPR. It is anticipated that solutions to these issues will include regulatory amendment,
policy development and operational adjustments. Issues identified during the Review
that require operational solutions will be referred to the BII for further analysis and
implementation.
Part 6 - Conclusions
The BII is designed to address the high demand for product licence approvals and will allow
Health Canada to move forward to meet the challenges resulting from the coming into force of
the new regulatory framework for NHPs. Health Canada will continue to keep Canadians
informed of progress within this initiative via the Health Canada website.
18
CHAPTER 3 – The Natural Health Products Regulatory Review
Part 1 – Review Objectives, Challenges and Guiding Principles
1.1 Objectives
As noted in Chapter 1, the review of the Natural Health Products Regulations (NHPR) is being
undertaken to respond to Health Canada's commitment to conduct a review of the regulations
with three to five years of coming into force. Revisiting/reevaluating new regulations is standard
practice and an essential element of good governance. A key objective for the Review is to
improve regulatory performance and ensure the sustainability of the NHP regulatory program.
Additional objectives of equal importance are that the Review aligns with regulatory
modernization initiatives within Health Canada and Health Product and Food Branch.
One of the essential elements driving the Review is the safety of Canadians. In making
the recommendations that eventually established the NHPR, the SCOH asserted that "All
members of the Committee share the same objective – that the health of Canadians must
remain as the most vital criterion underlying any regulatory analysis".1 Similarly, Health
Canada recognizes that its role must include, "minimizing health risk factors to
Canadians while maximizing the safety provided by the regulatory system for health
products."2
While the consultation process which is underway will provide the NHPD with feedback,
the NHPD will consider the level of health risks as well as work being done concurrently
on other regulatory frameworks in determining the appropriate regulatory changes to be
made.
On the whole, the desired outcome is a regulatory framework for NHPs that (1) protects
the health of consumers, (2) respects consumers' access to products, (3) guarantees
product safety and quality, and (4) ensures consumers can make an informed choice.
1.2 Challenges
The review process itself is not without its challenges. There were several key considerations in
designing the approach to the Review: primarily scoping and the complexity of the process.
As has already been mentioned in Chapter 1, it is very important that the Review recognize and
encompass the initial identification of a variety of issues by both external and internal
stakeholders, some of which are operational issues rather than fundamental regulatory problems
(discussed to in Chapter 2). As well as the concept of exceptions and outlying products which do
not easily fit within the NHP regulatory model. For example, in some cases, lower risk products
1 Report of the Standing Committee on Health, Natural health Products: A New Vision, (November 1998) ,
chapter 2, paragraph 2.
2 See Health Canada; About Mission, Values, Activities on line at : http://www.hc-sc.gc.ca/ahcasc/
activit/about-apropos/index_e.html.
19
may be over regulated currently while some higher risk products may more properly fit under
other existing regulations.
1.3 Guiding Principles
In looking then at these objectives and challenges for the Review, the following guiding
principles have been developed for the process.
The Review will:
• Respect the underlying principles/logic of the Food and Drug Act regarding the pre- and
post-market review of product classes based on level of risk.
• Identify and attempt to address regulatory lessons learned from parallel models of
regulatory health risk assessment from within Health Canada
The Review will NOT:
• Revisit and make direct changes to the core definition of what is a natural health product.
We will however consider reviewing the exclusions and inclusion criteria contained in
Schedule 1 and Schedule 2.
• Fully revisit all of the original recommendations of the Standing Committee on
Health (SCOH). We will however continue to build on the recommendations.
The purpose of the Review therefore is not to reassess the fundamental framework of the NHPR.
The purpose of the Review is to address the specific regulatory policy issues that have been
identified over the three years following implementation of the NHPR. It will seek to target
specific regulatory issues for refinement. While adjustments to operational procedures are
occurring in tandem with this Review (see Chapter 2), those operational challenges that do not
flow directly from the regulations are outside of the scope of the Review.
Part 2 – Why is it Time for a Regulatory Review?
Regardless of how precise or exhaustive they may appear on implementation, no set of
regulations can anticipate every eventuality or eliminate the need for interpretation, clarification
or amendment. The NHPR and their implementation are no exception.
There are several reasons why now is the appropriate time to initiate a review of the regulatory
process for NHPs as is summarized in the following listing.
(1) A 3-5 Year Commitment for Review
As of January 1st, 2007 the regulations have been in operation for three years. Reviewing
the regulations at this early stage allows us to meet the commitment that was made by
Health Canada to review the operation of the regulations within the first 3 to 5 years of
their coming into force and to ensure that the NHPR is on the right course.
(2) Lessons Learned
20
Over the past three years, NHPD has been listening to the concerns of its stakeholders
regarding the regulations. The implementation of the NHPR has allowed the identification
of issues that could only become apparent in translating the regulations into action.
(3) Housekeeping Amendments and the Continuity of the Regulations
NHPD has heard from the Standing Joint Committee for the Scrutiny of Regulations
(SJCSR) regarding a collection of technical housekeeping amendments that are required to
maintain the consistency of the NHPR. In responding to the recommendations of the
SJCSR, NHPD will strive to ensure the continuity and clarity of the regulations.
(4) Harmonizing with Blueprint for Renewal
Health Canada has initiated processes to modernize its regulatory practices. As part of the
Blueprint for Renewal Health Canada as a whole is striving to reorient the health product
and food regulatory system to better align with modern realities. The Review represents an
opportunity to strive to meet the broader goals as articulated in the Blueprint.
(5) Keeping Pace with other Branch Initiatives
There is an opportunity to ensure coherence and synergy with the other regulators in Health
Canada's Health Protection and Foods Branch (HPFB), as well as other Government
partners, such as the Canadian Food Inspection Agency (CFIA). Other regulatory program
areas of the HPFB have recently, or are current
