Natural and Non-prescription Health Products Priorities & Updates Health and Beauty Conference CHP Canada and CCTFA September 19, 2014

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1 Helping the people of Canada maintain and improve their health Aider les Canadiens et les Canadiennes à maintenir et à améliorer leur état de santé Natural and Non-prescription Health Products Priorities & Updates 2014 Health and Beauty Conference CHP Canada and CCTFA September 19, 2014

2 Overview Consumer Health Products (CHPs) CHP Framework Branch Priorities Non-prescription drugs (NPDs): Attestation & other pilots Looking Forward Questions and Answers Vision: Healthy Canadians, through self-care. 2

3 Consumer Health Products Framework In July 2013, the review of NPDs and disinfectants was transferred to the Natural Health Products Directorate (NHPD). To reflect this change, in June 2014, NHPD changed its name to the Natural and Non-prescription Health Products Directorate (NNHPD). This change was a pre-cursor to the development of a framework for consumer health products. Consumer health products include NHPs, NPDs, disinfectants, and cosmetics. In June 2014, the Minister of Health announced the intent to consult on the following proposal: lower-risk products be separated from the framework for prescription drugs, and be moved under a new framework for consumer health products. 3

4 Priorities Work is also underway on: The Plain Language Labelling (PLL) Initiative: PLL Regulations for non-prescription drugs will come into force on June 13, While not mandatory for NHPs, PLL is recommended and will be further outlined in NHP guidance as a best practice. A consultation is planned for November 2014 on the Draft Good Label and Package Practices (GLPP) Guide, including the Product Facts Table format. Brand name assessment guidance for consumer health products is under development; consultation is planned for winter

5 Priorities (cont ) Sunscreens: The directorate is finalizing a document for sunscreen products for consult in fall The paper will propose options for addressing challenges relating to product and establishment licensing, sampling, labelling, international alignment and red tape. The Prescription Drug List and scheduling: Examining Branch governance Looking at trade notification Taking advantage of new flexibilities 5

6 Non-prescription Drug Attestation Pilot Beginning on August 11, 2014, a Non-prescription Drug Monograph Attestation Pilot was launched for a period of six (6) months. Building on pre-cleared information best practices for NHPs, applicants may fully attest to eight (8) established monographs such as sunscreens and antidandruff products. The standard of evidence remains the same as many NPDs are already supported by high quality monographs. For the duration of the pilot, the NNHPD will audit the process and follow up with companies as appropriate. At the close of the pilot, the overall success will be evaluated, including to determine the appropriateness of expanding the pilot to other product lines, with the end goal of aligning appropriate oversight of all products that fall within NNHPD s purview. 6

7 Looking Forward: NHP Compliance and Enforcement Risk to health continues to drive compliance and enforcement priorities and actions level of risk generally determines the extensiveness and timeliness of the risk mitigation actions expected. Greater focus on the use over time of proactive compliance generation and monitoring to better enable the identification and targeting of risk, leading to more effective, predictable and consistent compliance and enforcement risk-based decisions. Identify opportunities for compliance education and monitoring to support compliance throughout the supply chain. Make available data and information on compliance and enforcement incidents, actions, and outcomes across product lines under Health Canada s Regulatory Openness and Transparency Framework. 7

8 Food for Thought The roles of health professionals such as pharmacists, naturopaths, nurses, etc. are expanding to include new activities (e.g. prescribing rights). How do we ensure that drug scheduling keeps pace with the evolution in health care, particularly how consumers perceive and use health products? What opportunities are there for us to work together (and with non-government organizations) to provide better information to consumers about CHPs? 8

9 Thank You! Questions & Answers 9

10 Annex: International Initiatives Work continues on international alignment and red tape reduction with the U.S. FDA (Regulatory Cooperation Council) and Australia TGA (Regulatory Cooperation Initiative). Exploring opportunities to develop joint agency documents (e.g. monograph and guidance) and work sharing activities (e.g. joint review). On May 30, 2014, Health Canada and the TGA released labelling standards for nonprescription topical nasal decongestants and nonprescription oral adult expectorant cough and cold. As outlined in the recent Regulatory Cooperation Council Joint Forward Plan on August 29, 2014, we will continue to coordinate and adjust our NPD monograph development processes with the U.S. FDA to reduce the regulatory burden on stakeholders. 10

11 Annex: NPD Performance Standards Submission Type Division 8: Fiscal Year Fiscal Year Q1 August 2014 NDS 100% 100% - SNDS 100% 100% - NC (not cost recovered) Division 1: 100% 100% - DINF 94% 94.9% 100% DINA 91% 90.5% 100% PDC (not cost recovered) 59% 58.1% 100% 11

12 Annex: NHP C&E Roles and Responsibilities Regulated parties that sell, manufacture, package, label, import, distribute or advertise NHPs in Canada are responsible for ensuring that the activities they conduct and the products they sell are compliant. Regulated parties are encouraged to consult Health Canada s website for information on the regulatory requirements and supporting administrative documents such as the Natural Health Products Compliance and Enforcement Policy (POL-0044) Questions or comments may be submitted to: Insp_NHP_PSN@hc-sc.gc.ca Regulated parties may use the Licensed Natural Health Product Database (LNHPD) to confirm the licensing status of NHPs, and other important information such as the approved claims, dosages and any label warnings. The LNHPD is available at: 12

13 Annex: NHP Performance Standard Overview Past Standard Compendial 60 days 44 % Full Review 180 days 56% Current ( March-August 2014) Class I 10 days 43 % Class II 30 days 20 % Class III 180 days 37 % Target Standard ( Objective to obtain) Class I 10 days ~60-70 % Class II 30 days ~30-35 % Class III 180 days ~1-5 % Ambitious goals were proposed in original approach Current approach continues to move toward fulfilling commitments 13

14 Annex: NHP Performance Standards: Where We Are Now 14

15 Annex: NHP Class II Expansion Pilot As communicated to stakeholders in August 2014, a Class II Expansion Pilot has been launched for the period of August 1, 2014 to February 1, Work continues to meet targets by defining and expanding Class II (30-day performance target). Class III files (180-day performance target) are being examined to determine if less time for review is required. Applicants may receive a decision or information request notice sooner than expected. We have received a total of 454 PLAs; of those, 170 have been screened into the Class II Expansion Pilot. 15

16 Annex: NHP Site Licensing Between January and June, 2014, Health Canada launched consultations on a revised approach to site licensing that included: A Revised Approach to NHP Site Licensing Proposal Document (consultation closed April 23) Site Licencing Guidance Document (consultation closes September 12) Good Manufacturing Practices Guide (consultation closes September 12) Quality Assurance Report Form (consultation closes September 12) During regular bilateral association meetings, there was a commitment to launch a pilot in fall In preparation for that, a mini-pilot involving four (4) audit organizations and seven (7) volunteer companies began in January and closed in August. A summary of the mini-pilot will be made available. 16

17 Annex: NHP Site Licensing (cont ) The key themes that emerged from the consultation were: general support for the on-site pilot program request for additional details around the on-site audit procedure and process comments regarding the scope of the third-party auditor criteria The documents are being revised based on consultation feedback and the results of the mini-pilot Activities for fall 2014: final site licensing documents to be published pilot will begin site licence holders webpage will be launched that identifies approved third-party auditors and sites that have undergone on-site audits 17