Accomplishments & Looking Ahead

• Approximately 20,700 product licenses issued since 2004, representing ~27,000 products
• More than 1,150 companies hold product licenses
• Recently issued the 1000th site license
• Inaugural Program Advisory Committee (PAC) established; comprised of stakeholder representatives
• Call for nominations for the permanent Program Advisory Committee to go out Thursday, May 20, 2010
• Three working groups established under PAC; Standards of Evidence, Testing, Compliance & Enforcement. First two groups have submitted their reports to NHPD, anticipating a response to their recommendations at next PAC meeting, June 14-15, 2010
• Online solution, consisting of a series of tools (including e-PLA, Natural Health Products Ingredient Database, Poste CS) is moving forward; additional workshops to be held in the fall to update stakeholders on this initiative; ~135 companies have submitted e-PLAs; homeopathic products are the only category with end to end capacity – meaning the entire product license application can be completed online
• International Trade Certificates (ITC) are being issued in 30-40 days; >7500 ITCs issued in 2009
• Ongoing work regulatory review action plan posted on website; performance improvement initiatives continuing, e.g. 11 abbreviated labeling standards added to available precleared information (PCI); Comments received on Schedule F proposals (allowance for OTC use of 11 naturally sourced substances) being evaluated; interface issues still a challenge (food:NHP and cosmetic:NHP/drug

The Future: Natural Health Products (Unprocessed Product License Applications) Regulations

• Regulatory amendment proposed, intent of which is to allow legal sale of a certain group of products; lifts the prohibition on sale of unlicensed products; all other aspects of the NHP regulations apply
• Affects ~12,000 products that are currently not licensed
• Stand alone regulation under the Food & Drugs Act; allows for legal sale with an exemption number
• 30 day consultation period (until June 7, 2010); could see possible publication in Canada Gazette, Part II in Summer 2010 (mid July at the earliest)
• Products would be eligible for a exemption number if they have been in queue for 180 calendar days and not yet received a product license or been refused
• Exemption Number would need to be shown on label within a “reasonable period of time”
• NHPD needs to ensure systems and resources are in place in anticipation of adoption of regulations; need a product license application management system
• Product claims are not evaluated for an Exemption Number, however safety is
• Applicant must attest that product does not meet risk criteria (i.e. sterile products, prohibited substances, Schedule A claims, for use in children under 12, for use in pregnant or breastfeeding women, contains an ingredient that has been subject to recall or stop sale)
• Company and product information to be posted on website with Exemption Number
• Amendment will end 30 months after coming into force- only a temporary solution
• An Exemption Number would not affect the issuing of ITCs- would still need a Product License and/or Site License

Sara O’Connor
A/Head, Product Submission Coordination Unit, Natural Health Products Directorate, Health Canada

• 12,976 applications still in backlog, 80% have been completed (licensed, refused, withdrawn); 99% have been addressed (issued an IRN, licensed, refused, withdrawn); outstanding applications include enzymes- trying to develop precleared information for enzymes
• ~24,000 applications have been received since April 1, 2008; 79% have been completed
• Increased completion rate due to:
• Increased quality of applications
• Online end to end pilot project for homeopathic products
• Increased number of applications referencing monographs and other  precleared information since beginning of 2010
• Increased NHPD support / guidance for acceptable claim wording
• Increased availability of scientific information to support safety and  efficacy, e.g. CLA
• Availability of new tools to support complete, quality applications, e.g. Evidence Assessment Template and Evidence Criteria
• Development of Finished Product Specifications Template
• Onus on applicant to meet specifications and to use approved methods (~400 approved methods in Natural Health Products Ingredient Database)
• Decreases evaluation time
• Was emailed to stakeholders via BEEP; not yet available on the website
• To be linked to e-PLA short
• Trying to increase efficiency of review of Multi Ingredient Non Traditional Applications by:
• Creating more precleared information
• Providing acceptable claim wording
• Use of an Issues Management Database
• Minimizing duplicate reviews
• Leverage science resources
• Upcoming Changes to increase PLA quality:
• Initial assessment of evidence to be done on all application types prior to acknowledgement.
• E-IRNs will no longer be issued. Only complete PLAs will be acknowledged.
• There will no longer be automatic extensions for IRNs, requests will be evaluated before an extension is granted.
• Upcoming changes to decrease review time of non compendial PLAs:
• Increase strategic development of precleared information
• Formalize review stream for applications attesting to precleared information
• Emphasized use of Finished Product Specifications Form
• All ingredients must be listed in the Ingredient Database before an application is filed
• Changes to be made to IRN template to clearly identify allowable changes
• Other changes:
• Automate where possible, decrease paper burden, increase speed of communication, get to the point where e-PLA is the only acceptable form of application
• Increase stakeholder training in electronic tools
• NHPD creating separate emails for product licensing, site licensing and clinical trial needs

• Applicants need to:
• Ensure claims supported by evidence or use PCI
• Use checklists and other tools to ensure complete, quality applications
• Withdraw theoretical and discontinued product license applications
• Work with Submission Coordinator

Diana Dowthwaite
Director General, Health Products & Food Branch Inspectorate, Health Canada

Compliance Overview
In the past two years:

• >150 NHPs have been recalled; 43 of which were a Type I health risk (imminent and serious health hazard)
• 557 complaints involving NHPs were received
• 258 samples were analyzed by HPFBI labs (chemicals, heavy metals, drugs)
• 150 public communications on health risks and NHPs were issued

Need for a revised compliance policy as all target dates have passed and increasing numbers of NHPs are being licensed.

The new compliance policy will:

• Replace and supercede the existing compliance policy
• Be based on fairness, transparency and uniformity
• Apply to all NHPs except those used in clinical trials
• Have an annex, if need be, to deal with the regulatory proposal
• Be a risk based approach
• Risks will be classified as “Higher Risk”, e.g. no product license, product adulteration, Schedule A claims; “May pose a risk”, e.g. GMP violations, dosage errors, false and/or misleading advertising; “Lower Risk”, e.g. technical labeling
• Be based on the expectation that all products on the market will have a license
• The new compliance policy is anticipated to take effect in the Summer of 2010, with a 4-6 month transition period and full implementation by year end
• Underlying considerations are that the backlog will have been addressed, an application management system has been put in place and the regulatory proposal may/may not have been passed
• There will be stakeholder outreach regarding the new policy during May and June 2010
• Need to move towards performance targets to give market stability and predictability
• Regarding GMPs and site licensing the NHPD and Inspectorate are moving towards an “on-site” program in fiscal year 2010/11

Dr. William Yan
A/Director, Bureau of Nutritional Sciences, Food Directorate, Health Canada

• Responsible for food safety and nutrition policies
• Increased resources made available to Food Directorate to work on priorities through Agriculture Canada’s Growing Forward initiative
• Food NHP interface products still a major challenge; ~1,000 applications received
• Intent is to transition applications to Food Regulations; however, need to increase regulatory flexibility regarding fortification and claims first
• Proposed amendments to food fortification policy in 2005 met with concerns from certain stakeholder groups regarding discretionary fortification; thus looking at other ways to move changes forward; recent Think Tank with stakeholders supported the need for flexibility and innovation regarding food fortification but expressed concern regarding over consumption of nutrients
• Option to use Interim Marketing Authorization (IMA) Regulations to allow some innovative (fortification and/or claims) products access to market
• Products need to meet fortification criteria
• Must not be harmful to consumers
• Regulatory amendment is appropriate and will be proposed
• Can also use Temporary Marketing Authorization (TMA) Regulations to put a non compliant food product on the market while gathering information in support of a regulatory amendment
• Food Directorate moving ahead with 5 additional generic health claims; also published a guidance document on the use of probiotics in foods and allowable claims