Process Updates and Improvements in the Natural Health Products Regulatory Industry

Transcription

1 Process Updates and Improvements in the Natural Health Products Regulatory Industry Manon Bombardier, Director General Natural and Non-Prescription Health Products Directorate (NNHPD), Health Canada February 22, 2018

2 Site Licence Applications January to December 2017: Stream 1: 35 days - Pre-cleared GMP evidence for every site Stream 2: 65 days - <10 sites and include a QAR for one or more site Stream 3: 95 days sites and include a QAR for one or more sites Site Pre-Licensing Applications Post-Licensing Amendments, Notifications, and Renewals Licensed Refused Withdrawn Accepted Refused Withdrawn Total Completed Stream I Stream II Stream III Total Notifications

3 Product Submissions Received By Class Type 2015 Q1 to 2017 Q Q Q Q Q Q Q Q Q Q Q Q03 Class I Class II Class III 3

4 Natural Heath Products Management of Applications Policy Objectives Increase the quality of applications submitted to NNHPD. Ensure licensed products meet regulatory requirements to adequately protect the health of Canadians. Improve process to deal with submission deficiencies and promote their timely resolution. Improve the review performance across the program. Improve consistency in review across program and predictability for industry Key Deliverables: Natural Heath Products Management of Applications Policy (NHP MAP) Electronic Product Licence Application (epla) Product License amendment and notification Form (PLAN) Updated Monographs 4

5 Post-Licensing Amendments Criteria for Refusal Service Standards Information Request Notices (Class II & III) Method of Submission Proposed Natural Heath Products Management of Applications Policy Updates Current Not required for changes to parameters supported by a monograph for Class I licences Limited list of refusal issues Class I: 10 Business days Class II: 30 Calendar days Class III: 30 Calendar days for screening Calendar days for review Limited timeline for response (2 days) Paper by mail/courier Electronic by epost or CD/DVD by mail/courier Proposed Changes required for all products aligning with NHPR Sections 11&12 Full comprehensive list of criteria for refusal Class I: 60 Calendar days (target of 30) Class II: 90 Calendar days (target of 45) Class III: 210 Calendar days Timeline for response will be increased to up to 5 days Electronic by epost or CD/DVD by mail/courier Only 5

6 Engagement Timeline: Natural Heath Products Management of Applications Policy Feb 14 April May Summer Fall In-person technical session held. Proposed NHP MAP for written feedback period. Info session on changes to NHP MAP to address questions and concerns. Complete updates to monographs & post online. Publish final Guidance. Included stakeholders from targeted industry associations Collected early feedback on proposed changes prior feedback period 6

7 Reconsideration Process Objectives Transparency Exchange of all information used, including clear rationale for the decision. Impartiality 1. Identify impartial reviewers with expertise required. (~70 days) 2. If no one within the Health Portfolio has not been previously involved, an external panel will be convened. (~140 days) Better Communication Applicants can choose a reconsideration process that is based on: (i) review of written submission; (ii) teleconference; (iii) in-person meeting. Final reconsideration decision will be signed off by the NNHPD DG. 7

8 Engagement Timeline: Reconsideration Process Context: Section 9(3) of the NHPR provides for the reconsideration of natural health product (NHP) applications that have been refused by NNHPD. Note - Food and Drugs Act Liaison Office (FDALO) is located in the Communications and Public Affairs Branch of Health Canada May 2015 Feb-Nov 2016 Oct 2017 Current Spring 2018 Spring-Fall 2018 EoY 2018 FDALO Working Group created. NNHPD led a transparent and impartial pilot. FDALO findings and path forward favourably received at multilat. Continue new approach, building on feedback To help shape new Guidance. Share draft Guidance for feedback. Analyze and incorporate feedback. Publish final Guidance. 8

9 Online Forms and Statements to the Effect Of Alysyn Smith, Champion of Operational Readiness Natural and Non-Prescription Health Products Directorate (NNHPD), Health Canada February 22, 2018

10 Online Forms Project Development Items Expected Outcomes Year 1 Electronic Product Licence Application (epla) New Amendment and Notifications Form (PLAN) 55% reduction in attestation failures through controlled lists and forms Enhanced client interface & usability Decreased administrative burden (filing and processing) Added flexibility and condensed process Year 2 Mandate electronic submission via policy Web-based data validation model in conjunction with epla o SAS Data Quality Increased industry uptake Eliminate attestation failures prior to licensing Eliminate need for post-market audits Mitigate compliance and risk management activities related to attestation failures 10

11 Online Forms Benefits HPFB IT Themes For Canadians Licensed products that meet safety, efficacy and quality requirements to protect the health and safety of Canadians Consistent information for product labels For Industry For Health Canada Enhanced and simpler usability Increased electronic submission uptake: o Improved quality of submissions o reduced red tape o Increased processing efficiencies o Timely approvals Reduced liability risk from failed attestations Increased credibility and trustworthiness High quality of submissions (reduced processing time and resources) Improved capacity to focus on high risk applications Sustainable and scalable technology platform as foundation for self-care framework Safety of Canadians Client facing Business gains Aging IT 11

12 Statements to the Effect of Attestation failures create health, liability and reputational risks Statements to the effect of introduce subjectivity and cannot be validated by an IT system Immediate regulatory outcomes sought: Safer products Increased predictability for industry More efficient use of regulator's resources Performance standards met Ultimate regulatory outcome sought: All NHP applications (product license against monograph) meet all monograph requirements 12

13 Class I Class II & III Pre-populated Fields Yes Fully Yes Some Free-Text Fields No Yes Some Autopopulate Monograph Details Yes New Web-Based Form Single ingredient and product Yes Deviations allowed through free-text *Screening will determine if deviations will be Class II or Class III Additional Screening No Yes Combination products not pre-cleared Process Statement to the effect of no longer be allowed. Submission Intake Class I New guidance to be developed. Submission Intake Procurement & Screening License Class II Decision Class III 13

14 Feedback & Next Steps brackets () and slashes / Traditional use and Used in herbal medicine Feedback received More consistent Consistent use of these claims Response Brackets optional Slashes = and or Not synonyms Traditional language Modernize When intent of claim is not lost Additional synonyms Allow for When words have some intent February / March March Winter / Spring Late Summer Fall PLAN form and guidance released Webinar with tutorial and opportunity to ask questions. Re-Publication of revised monographs Release of epla Publish final Guidance. 14

15 Questions or Feedback? Natural and Non-Prescription Health Products Directorate (NNHPD) Calendar of Activities OR Contact us directly at 15

16 Self-Care Framework Presented to CHFA West February 22,

17 Purpose To provide information on: Overall objectives of the framework Summary of policy proposal Update on status and next steps 2

18 What are self-care products? Cosmetics Used for cleaning, improving or altering the complexion, skin, hair or teeth (e.g., moisturizing creams, deodorants, shampoos) Natural health products (NHPs) Various uses including general health maintenance (e.g., mineral supplements, probiotics, traditional medicines) Non-prescription drugs (NPDs) Commonly referred to as "overthe-counter drugs" (e.g., pain relief, cold & flu symptoms, allergy relief) Self-care products are used every day to maintain health, treat minor ailments and improve appearance, without requiring an intervention of a health care practitioner. Self-care products are generally lower risk than other health products regulated by Health Canada, such as prescription drugs. However, they are not completely without risk as they can cause negative effects if combined with other medications or if not used as directed. 3

19 Overall Objectives of the Self-Care Framework 4

20 Policy Elements Market Entry Product Categorization Product Claims and Evidence Product Registration and Product Licensing Labelling Product Labelling Advertising Post-market Compliance Monitoring & Verification Site Licensing Scheme Quality Standard Vigilance 5

21 What We Know Right Now Resetting the Stage NPNs will be maintained Regulatory frameworks are not being collapsed Changes would be in the NHPRs No disclaimers being proposed Maintaining pathway for licensing for evidentiary standard 6

22 Information for consumers Better labelling to help consumers with product identification, selection and use, to support informed decision-making This would include consistent content and format that is easy to read and understand A facts table for all self-care products Use of a URL to provide additional information for the consumer Improved labelling, similar to the approach used in the US for dietary supplements 7

23 Information for Consumers: Content Introduce the requirement for improved labelling of NHPs (readable and understandable) Introduce the requirement for a facts table Specific requirements for the facts table, including font size and type, contrast, color, etc Ability to simplify the format of the facts table Simplify label content in general, including making warnings and other risk statements shorter and easier to understand for the consumer Introduce rules to improve the disclosure of allergens 8

24 Information for Consumers: Format Introduce a facts table format for NHPs Introduce flexibilities to the facts table format for some or all NHPs Apply the title Product Facts to the table Expand the concept of point of selection (point of purchase) versus point of use labelling information to help minimize label info crowdedness, in a manner that makes sense for self-care products Take an approach that would not impede the adoption of new labelling solutions as technology advances Continue to explore flexibilities related to ingredient listing (MIs and NMIs) to reduce the likelihood of package changes 9

25 What would the standard table format look like? Product Facts title. Medicinal ingredients. Product Facts Medicinal ingredients Purpose Use(s).. Warnings Directions. Other information Non-Medicinal ingredients. Questions. Ingredient1 Purpose1 Ingredient2 Purpose2 Ingredient3 Purpose3 Uses UseA UseB Warnings Warning_a Warning_b Warning_c Directions First direction Second direction Other information Store at C Non-medicinal ingredients inactive ingredient1, inactive ingredient2, inactive ingredient3, inactive ingredient4, inactive ingredient5 Questions?

26 What would the flexible table format look like? Product Facts / Info santé (visit/visitez Medincinal ingredients / Ingrédients actifs Ingredient1, ingredient2, ingredient3 Warnings / Mises en garde Warning_a / MiseEnGarde_a Directions / Mode d emploi First direction / Premier mode d emploi Non-medicinal ingredients / Ingrédients inactifs inactive ingrédient inactif1, inactive ingrédient inactif2, inactive ingrédient inactif3, inactive ingrédient inactif4, inactive ingrédient inactif5 Questions? Webpage: Health Facts Product Name The physical outer label would contain only point of selection information, i.e. the information the consumer needs at the time of purchase. Use(s) would be on the principal display panel (main panel). The URL would take the consumer to the full Product Facts table with point of use information, i.e. the information the consumer needs to know when using the product distinct from the information that must be present at point of sale. Active ingredients Ingredient1 Ingredient2 Ingredient3 Uses UseA UseB Warnings Warning_a Warning_b Warning_c Directions First direction Second direction Other information Store at C Purpose1 Purpose2 Purpose3 Non-medicinal ingredients inactive ingredient1, inactive ingredient2, inactive ingredient3, inactive ingredient4, inactive ingredient5 Questions?

27 Oversight Proportional to Risk Products would be regulated according to risk to consumers, which is a relationship between benefit, harm and uncertainty Benefit Harm Authorization for lowest risk (Route I) Health Canada will not review efficacy for each product of lowest risk, and will focus on safety and quality being pre-established Claims will relate to symptoms & minor conditions rather than stronger disease claims Uncertainty Risk Authorization for higher risk products (Route II) Products will require the review of scientific method based evidence (safety, efficacy or quality) to Health Canada prior to marketing due to its higher risk 12

28 Oversight Proportional to Risk - Feb 2018 Cosmetic-like (Route I with exemptions) Benefit: no/low therapeutic value Cosmetic Lowest risk cosmetic-like drugs: such as acne, anti-dandruff, secondary sunscreens, toothpaste, mouthwash that have a well-established history of safe use in Canada Route I Route II (or X) Benefit: low-moderate therapeutic value Other products set out in Cat IV monographs General wellness products, health maintenance, symptomatic relief of conditions that either self-resolve; or are well established for chronic use, or have an established history of safe use for a purpose in Canada AND AND OR Harm: mild Products intended to have a topical and localized effect (excluding broken skin application) Non-ingestible (teeth, gums, mouth) Excluded products (see Route II) Harm: mild Other drugs intended for use on the skin, mouth, teeth or gums Products intended for a systemic effect, including topical and non-topical (e.g. ingestible) Other products that establish a history of safe use in Canada when used as directed that are eligible to be listed on the register Excluded products (see Route II) AND AND OR Uncertainty: low Known (i.e. is on the register because has been assessed/screened previously to have a well-established safe use) Uncertainty: low Known (i.e. is on the register because has been assessed previously to have a wellestablished safe use) High certainty for low impact on population health concern Benefit: moderate-higher therapeutic value Products that confer a higher benefit (e.g. claims for diseases and conditions not established in the register, symptoms that do not self-resolve or not established for chronic use, and any reference to a major disease) Harm: moderate-higher Ingredients of higher risk/concern, which could include: NSAIDs corticosteroid antiviral antibiotic sterile erectile dysfunction PPIs weight loss Uncertainty: higher Unknown (i.e. the product/ingredient/claim has not previously been assessed under the product s proposed recommended conditions of use) Certainty for impact on population health concern 13

29 Oversight Proportional to Risk - Feb 2018 Cosmetic-like (Route I with exemptions) Route I Route II Labelling: General principles of plain language Modernized contact info Allergens to be disclosed Facts table (optional) Compel label Labelling: General principles of plain language Modernized contact info Allergens to be disclosed Facts table (required) - streamlined Compel label Labelling: General principles of plain language Modernized contact info Allergens to be disclosed Facts table (required) Compel label Compliance & Enforcement: Compliance Monitoring/Verification lower priority in absence of extenuating factors, such as contamination, could move issues up Compliance & Enforcement: Compliance Monitoring/Verification the inspection program would focus on higher risk activities and those with a history of non-compliance. Medium priority in absence of extenuating factors, such as contamination, could move issues up Site Licence not required Site Licence required for: manufacture, package, label, import, and test Quality Standard recommended sanitary conditions Compliance & Enforcement: Compliance Monitoring/Verification the inspection program would focus on higher risk activities and those with a history of non-compliance. Medium priority in absence of extenuating factors, such as contamination, could move issues up Site Licence required for: manufacture, package, label, import, and test Quality Standard required Quality Standard required Vigilance: Report serious domestic adverse reactions and serious unexpected foreign adverse reactions Monitor and assess safety information (reports submitted based on risk) Summary reports developed and provided upon request Vigilance: Report serious domestic adverse reactions and serious unexpected foreign adverse reactions Monitor and assess safety information (reports submitted based on risk) Summary reports developed and provided upon request Vigilance: Report serious domestic adverse reactions and serious unexpected foreign adverse reactions Monitor and assess safety information (reports submitted based on risk) Summary reports developed and provided upon request 14

30 Route I and II Authorization Route I (exemptions) Note: Not appropriate for higher-risk ingredients Route I NOTE: Not appropriate for higher-risk ingredients Route II NOTE: Higher risk ingredients and uses For treatment of acne Helps prevent dandruff Helps relieve diaper rash Helps in development of teeth and gums Prevents cavities Mouthwash Shampoo Relieving dry skin Hair growth (topical use) Teeth whitener Secondary sunscreens Source of antioxidant Homeopathic product for teething Traditionally used in Herbal Medicine as a nutritive tonic Minor skin irritations Helps in absorption of calcium Relieves (itching, burning, cracking, etc.) of athlete's foot Fish oil Cough and cold Temporary relief of pain Relief of symptoms of irritable bowels Helps affect mood Hair growth (ingestible) Enzymes/probiotics New ingredients New conditions of use Relief from allergies Chronic relief of pain Prevention of nausea, vomiting and dizziness associated with chemotherapy Helps treat infection Treatment/cure of a yeast infection Treatment of fibromyalgia Pink eye cure For relief of heartburn, indigestion (PPIs) Anti-inflammatory (NSAIDs) Mental health/illness Flu 15

31 Status and Next Steps Continuing targeted consultations Undertaking consumer research Timing for implementation Cost-benefit survey - Webinar to support detailed understanding 16

32 For more information: Visit the Health Canada self-care framework website Contact the Health Canada self-care framework team by 17