Natural and Non-prescription Health Products Directorate (NNHPD) June 1, 2018-December 31, 2018 Engagement and Priorities

1. Self-Care Framework

Health Canada is updating its approach to regulating self-care products with the aim of aligning the levels of oversight with risk to the consumer and helping consumers make better informed decisions.

Further to the feedback received during our 2016-2017 engagement activities, Health Canada will proceed with the update in phases, to reduce potential impacts on the marketplace and allow impacted stakeholders time to implement changes.

• Phase I:  In Fall 2018, Health Canada will propose regulatory changes for improved labelling of natural health products (NHPs).
• Phase II:  In early 2019, Health Canada will propose regulatory changes to introduce a risk-based approach to the oversight of non-prescription drugs.

At a future date, Health Canada intends to introduce further regulatory amendments to address evidence standards for similar health claims, extend risk-based regulatory oversight to NHPs and cosmetics, and seek additional powers for Health Canada.

For information on the next steps please visit: https://www.canada.ca/en/health-canada/services/self-care-framework.html

We will continue to engage Stakeholders as the regulatory proposals are developed.

2. Management of Applications Policy (MAP)

The NNHPD is undertaking updates to its policy on the Natural Health Products Management of Applications Policy (NHP MAP).  The NNHPD last updated its NHP MAP in 2014. Since then, the NNHPD has identified what works well, what can be improved, and what measures are needed to enhance the quality of applications and streamline the licensing process for NHPs. These measures have not yet been reflected in policy.  The policy updates are intended to align with current practice and achieve better results for the health and safety of Canadians. Stakeholders will be invited to provide their input into the updated draft document during a 60-day written feedback period beginning in September 2018. A consultation webinar will take place in late September 2018. The timetable for the updated policy is intended to align with the launch of the new web-based version of the product licence application (ePLA) in early 2019. Please refer to the calendar of engagement at the end of this document for upcoming engagement opportunities.

3. Plain Language Labelling (PLL)

A "lessons learned" session on the 1-year implementation of PLL for non-prescription drugs, took place on May 23, 2018 to incorporate internal and external feedback received, following the PLL implementation. As a result of this exercise, a draft updated Labelling Requirements for Non-prescription Drugs Guidance Document (formerly CDFT Guidance Document) was released on July 13 for consultation. This version incorporates feedback received in preparation and during the May 23rd session, the proposals for new font styles and Canadian Drug Facts Table (CDFT) headings and subheadings, as well as the new flexibility for Category I products as defined in the context of the Self-Care Framework (SCF). Stakeholders were invited to attend a webinar on July 20 to ask questions about the revised document and provide written feedback by July 30. We are continuing to work on monograph updates to facilitate the use of the proposed new PLL flexibility for Category I products. These revised monographs will be shared for consultation between August and October 2018. More details on engagement related to PLL is available at the end of this document.

4. Natural Health Products Reconsideration Process

The NNHPD has worked with the Food and Drugs Act Liaison Office (FDALO) to propose a new reconsideration process for NHP license refusals. The NHP reconsideration process will be harmonized with the human drug model where appropriate. The draft guidance document, Reconsideration of Decisions Issued for Human Drug and Natural Health Product Submissions, was sent on June 25, 2018, to interested parties for a 60-day consultation period.  Following FDALO’s review of comments received, the guidance will be updated and posted in the Fall of 2018.  

5. Updates to the Natural Health Products Online Solution

In February 2018, the NNHPD released the revised electronic Amendment and Notification form for licensed NHPs. A webinar outlining the step-by-step process to use the new tool is anticipated in the Fall of 2018.

A web-based version of the product licence application (ePLA) form will be released in the Fall of 2018. Its development will be guided by the input received from previous engagement sessions and will ensure that it meets the needs of end users while satisfying the program's regulatory requirements. User testing with identified Stakeholders, will occur in August. Testing will be focused on the usability of the forms. Please refer to the calendar of engagement provided at the end of the document for more details.

6. Monograph Publication

Monograph updates constitute a continuous activity for the NNHPD. This includes the finalization of monographs currently in draft form and updates to existing monographs to improve clarity and comprehension.  Stakeholders will continue to be engaged on newly published and anticipated revisions to existing monographs. However, unanticipated revisions or those made in exigent circumstances, such as those resulting from pharmacovigilance activities, will continue to be published without consultation.

The Compendium of Monographs Guidance Document will be updated to reflect changes related to the “Statements to the Effect of” (STTEO). It will be posted for consultation in Fall 2018. Additionally, the NNHPD is working to update monographs to address the removal of the STTEO for Class I. This flexibility of wording introduced a level subjectivity that has been a source of attestation failures and cannot be validated by an IT system. For this reason and for ease of use, the NNHPD is transitioning towards the new electronic Product License Application (ePLA) and is adjusting monographs to allow data validation. There will be a drop-down menu with options to select from. Any deviations from the monographs will be reviewed in the Class II or III. We appreciate the thoughtful and analytical input provided by industry on claims for many of the monographs as part of this initiative.

On July 18, 2018, a teleconference call with interested Stakeholders was held to provide an update on how industry feedback was incorporated within monograph updates.

A list of monographs are set to be published in accordance with the following dates:

Monograph Bundles	Description		Timeline
Bundle 1	Aloe Vera- Oral Aloe Vera- Topical Angelica Calcium Potassium Coenzyme Q10 Conjugated Linoleic Acid Creatine Monohydrate Ephedrine, L- Figwort Garlic Gingko Biloba Glutamine, L- Hydrolized Collagen	Hyssop Malabar Tamarind Marshmallow - Leaf Marshmallow - Root Melatonin - Sublingual Propolis - Topical Propolis - Buccal Propolis - Oral Royal Jelly Rutin Spirulina Turmeric - Oral Turmeric - Topical	July 2018
Bundle 2	Acai - Euterpe oleracea  Aloe vera Leaf Gel - Oral Arginine, L- Birch Weeping Black Cohosh  Black Horehound Bovine Colostrum  Caffeine  Calendula - Buccal  Calendula - Oral  Calendula - Topical Curcumin  Fenugreek - Oral  Fenugreek - Topical Ginseng, American Ginseng, Panax	Glucosamine sulfate Grape Seed Extract  Green Coffee Bean Extract Green Tea Extracts Maca Melatonin - Oral Milk Thistle Peppermint Red Clover Red Wine Extract Resveratrol Thuja - Oral Thuja - Topical Ubiquinol	August 2018
Bundle 3	Borage Oil Bromelain - Fruit Bromelain - Stem Chlorella Cod Liver Oil Evening Primrose Oil  Fish Oil Flaxseed Flaxseed oil Joint Health Products Kelp Products	Krill Oil Multivitamin and minerals (MVM) Pseudoephedrine - Adolescents and Adults Pseudoephedrine - Children Saw Palmetto  Saw palmetto, liposterolic extract  Seal Oil Selenium Serrapeptase	September 2018
Bundle 4	5-HTP Bilberry - Buccal  Bilberry - Oral  Black Pepper - Piper nigrum Black Walnut - Juglans nigra Blessed Thistle - Oral  Blessed Thistle - Topical Burdock - Oral Burdock - Topical California poppy Cascara Sagrada Cayenne - Oral Cayenne - Topical Chamomile, German - Buccal Chamomile, German - Oral Chamomile, German - Topical Chamomile, Roman  Chaste tree	Dandelion Dandelion Juice Deglycyrrhizinated licorice - Buccal Deglycyrrhizinated licorice - Oral Fennel, Bitter Fennel, Sweet Ginger  Ground Ivy - Oral  Ground Ivy - Topical Kutki - Picrorhiza kuuooa Psyllium - Plantago afra  Psyllium - Plantago arenaria  Psyllium -Plantago ovata  Sage - Buccal Sage - Oral	October 2018
Bundle 5	Amla - Phyllanthus emblica  Carnitine, L- Cassia cinnamon - Cinnamomum aromaticum Chitosan Cinnamon Cranberry Cranberry juice, dried  Devil's Claw  Echinacea Angustifolia Echinacea pallida Echinacea purpurea Eleuthero  Globe artichoke Holy Basil - Leaf Holy Basil - Seed  Hops	Horse Chestnut  Horseradish Licorice Lysine                       Maitake  MSM  Olive leaf - Olea europaea Passionflower  Pomegranate Rosemary - Oral Rosemary - Topical Senna               Skullcap St. John's Wort - Oral  St. John's Wort - Oral - Hydroalcoholic Extract  St. John's Wort - Topical	November 2018
Bundle 6	Acne Therapy Anti-Dandruff Antiseptic Skin Cleansers Diaper Rash First aid antiseptic	Medicated Skin Care Oral Health Primary Sunscreen Secondary Sunscreen	December 2018
Bundle 7	3,3'-diindolylmethane (DIM)  Active hexose correlated compound - Granule (AHCC-FG)   Active hexose correlated compound - Powder (AHCC-FD)   African Wild Mango   Alfalfa   Amylase, alpha- Arnica - semisolid dosage forms  Arnica  Ashwagandha  Astragalus   Avens Bearberry - Arctostaphylos uva-ursi Birch, White Boldo Caraway	Carrot  Cellulase  Chymotrypsin Ephedra  European Pennyroyal  Frankincense - Oral  Frankincense - Topical Galactosidase, alpha-  Gentian  Indole-3-carbinol  Lactase Linden, European Linden, Large - leaf Linden, Small - leaf Papain Stinging Nettle Stinging Nettle - Juice	January 2019
Bundle 8	Beta-Glucan  Betaine / Betaine hydrochloride  Blueberry  Catnip   Chondroitin Sulphate   Citrus Bioflavonoids  Dong quai - Angelica sinensis  Elder - Sambucus  Feverfew  Glucomannan - Capsule  Glucomannan - Powder  Glucosamine hydrochloride Goldenseal - Buccal  Goldenseal - Oral  Hamamelis Water - Buccal Hamamelis Water - Ophthalmic Hamamelis Water - Topical	Hawthorn - Crataegus laevigata Hawthorn - Crataegus monogyna Heal-all - Buccal  Heal-all - Oral  Heal-all - Topical  Inulin Juniper Lipase Male Genital Desensitizers Mugwort Protease, Fungal  Rhodiola  Tribulus Trypsin	February 2019
Bundle 9	Alpha lipoic acid, DL- Free Plant Sterols Lecithin Lemon Balm  Lungwort - Oral Lungwort - Topical  N-Acetyl-L-Cysteine  Pancreatic Enzymes  Para Aminobenzoic Acid Phosphatidylserine Plant Stanol Esters Plant Sterol Esters Poria   Pygeum Quercetin	Reishi - Ganoderma lucidium  Soy Flour  Soybean Extracts and Isolates  Taurine Theanine, L-   Thyme - Buccal  Thyme - Oral Thyme - Topical Tomato Extract Tyrosine, L-   Valerian  White Kidney bean extract  White willow Witch Hazel - Buccal  Witch Hazel - Oral  Witch Hazel - Topical	March 2019
Bundle 10	Antioxidants Aromatherapy - Essential Oils Benzocaine Cognitive Function Products Corn & Callus Remover Counterirritants Digestive Enzymes	Flower Essence Gemmotherapy Homepathy Hydrocortisone Topical Laxative, Carbon Dioxide Releasing Laxative, Hyperosmotic Lithotherapy	April 2019
Bundle 11	Marigold Extracts and isolates Medicated Vapours Mushrooms Nosodes Oil Products Oligotherapy Organotherapy	Probiotics Traditional Chinese Medicine Ingredients Triphala Wart Remover Whey Products Workout Supplements	May 2019

7. Proactive Risk Management Projects

Quality of NHPs

As a result of the conclusions from the 2017-2018 Compliance Monitoring Project (CMP), the NNHPD is examining its approach regarding pre-market review of quality. Further details will be made available in late 2018-early 2019.

Next Proactive Risk Management Project

Another CMP, newly renamed Proactive Risk Management Project (PRMP) will be launched this year and include on-site visits to verify Good Manufacturing Practices (GMP) compliance of NHP sites.

8. Licensed Natural Health Products Database Data Extract (LNHPD)

A new self-serve Application Programming Interface (API) will be launched in Fall 2018 as part of the Open Governmental portal. The new portal will allow Stakeholders to extract data on demand in two different formats; JSON and XML. The previous text based extract will still be available for Stakeholders to access, however, it will not be updated with new information and users will be directed to the newer API, which will be located on the portal, for up to date information. Users are encouraged to reconfigure their software interfaces, if needed, to better utilize the format of their choice.

9. Appropriate Dosage Forms for Children

NHPs with solid dosage forms, such as tablets and capsules, may not be suitable for children less than 6 years of age if the product label does not provide specific instructions of use. Since May 2017, the NNHPD has been requesting, from impacted licence holders, that specific instructions for use in children be added to the label of already licensed products. The next phase of the initiative is expected to begin in Summer 2018 and will focus on Class II and III products (approximately 115 natural health products) with solid dosage forms for children.

10. Disinfectants

Concurrent with Phase II of the Self-Care Framework (SCF), the NNHPD will propose, in early 2019, a separate and discrete set of amendments under the Food and Drug Regulations to formalize current practice for hard surface disinfectants.

The guidance document Administrative Processing of Submissions and Applications: Human or Disinfectant Drugs, came into force on March 1, 2018. It will be implemented for disinfectants as of April 1, 2019. This guidance document replaces Changes in Manufacturer's Name and/or Product Name with the end goal of developing consistent practices around administrative drug submissions.  The new document will clarify the requirements for eligible drug submissions and applications that will be processed under the administrative pathway.

Upcoming Engagement

Priority	Description	Estimated Timeline	Targeted Audience
Self-Care Framework	Consultation of industry and health professional Stakeholders regarding the proposed improvements to the labelling of NHPs, including discussions on costs and time to implement changes.	Ongoing	Industry and Health Professionals
	Consultation with consumers on proposed improvements to the labelling of NHPs.	Summer 2018	Consumers
	Consultation with industry and health professional Stakeholders, regarding the proposed regulatory amendments to introduce a risk-based approach for non-prescription drugs.	Fall 2018	Industry and Health Professionals
	Public consultation on regulatory amendments to the Natural Health Products Regulations for improved labelling of NHPs (pre-publication in Canada Gazette, Part I).	Fall 2018	Consumers
	Public consultation on regulatory amendments to the Food and Drug Regulations to introduce a risk-based approach to the oversight of non-prescription drugs (pre-publication in Canada Gazette, Part I).	Spring 2019	Consumers
Management of Applications Policy	Draft policy will be shared by email for written feedback.	September 2018	Industry associations and interested applicants
	Webinar to answer and clarify questions on the draft policy.	Fall 2018
	Final policy document posted online to align with the launch of the new ePLA.	Early 2019
Plain Language Labelling (PLL)	Labelling Requirements for Non-prescription Drugs Guidance Document released for comment.	July 13, 2018	Industry Stakeholders
	Webinar to discuss Labelling Requirements for Non-prescription Drugs Guidance Document.	July 20, 2018
	Labelling Requirements for Non-prescription Drugs Guidance Document stakeholder feedback due.	July 30, 2018
	Monographs released in batches for feedback.	August - October 2018
	Publishing of the Good Label and Package Practices Guide (GLPPG), CDFT Guidance, eCDFT guidance, and Questions and Answers Document.	September 2018
	Roll-out of Category I (Self-Care) flexibilities for non-prescription drugs.	December 2018
Natural Health Products Reconsideration Process	Consultation on the proposed process.	June - August 2018	Industry Stakeholders
	Finalization of the Guidance Document Administrative Processing of Submissions and Applications: Human or Disinfectant Drugs.	Fall 2018
Updates to the Natural Health Products Online Systems	Teleconference call with update on industry feedback within the monograph updates.	July 18, 2018	Industry Stakeholders
	Electronic Product Licence Application (ePLA) testing with Associations and Applicants.	August 2018	Industry Stakeholders
	Compendium of Monographs Guidance Document posted for consultation.	Fall 2018	Industry Stakeholders
	Webinars outlining the step-by-step process to use the new tools.	September and October 2018	Industry Associations
	Release of a web and improved version of the Electronic Product Licence Application (ePLA) Form.	Late 2018, Early 2019	Industry Associations