Natural and Non-prescription Health Products (NNHPD) six-month calendar of activities: July to December 2014

This calendar presents an overview of anticipated Natural and Non-prescription Health Products Directorate (NNHPD), formerly the NHPD, review activities, publications, workshops and meetings, for the period of July to December 2014.

Under the Regulatory Roadmap for Health Products and Food, the Health Products and Food Branch continues to align oversight of all consumer health products (CHPs) based on their benefits, harms, and uncertainties.

Since the move of non-prescription (or over-the-counter) and disinfectant drug review functions to the NNHPD on July 1, 2013, the Directorate continues to work toward aligning standards of evidence for products of similar risk; thus allowing for reduced red tape and faster market access for industry for some low-risk product groups, such as sunscreens, while continuing to protect the health and safety of Canadians. To accurately reflect the expanded mandate of this Directorate, it has officially changed its name to the Natural and Non-prescription Health Products Directorate (NNHPD).

The NNHPD will make every effort to complete the following list of activities within the specified timeline; however, projects may change or be delayed due to shifting priorities.

This document is intended to supplement other information on activities provided by the NNHPD. Visit the "What's New" page to find information on new and recent releases.

1.0 Consultations

Some of the documents listed below may be published in final form during the same six-month period, depending on the timing and duration of consultations.

Consumer Health Product Framework Consultations:

Health Canada will launch consultations this fall on a new framework aimed at streamlining and updating the current regulations for certain lower-risk health products. These consultations will build on existing efforts to reduce unnecessary red tape for CHPs where warranted. These initiatives are in keeping with the Federal Government's overall strategy as part of the  Regulatory Cooperation Council Action Plan.

"A Revised Approach to Natural Health Product (NHP) Site Licensing":

This document was posted in January 2014, for a 90-day consultation. The document describes the NNHPD's proposed on-site audit pilot of NHP manufacturers, packagers, labellers and importers. The final version of the document is expected to be posted in the fall of 2014.

To support this initiative, the NNHPD will also be consulting on the following documents and publishing final versions of:

"Site Licensing Guidance Document":

• This document has been updated to clearly and concisely describe the process and requirements for obtaining a site licence. It has also been updated to take into account the on-site audit pilot.

"Quality Assurance Report (QAR) Form":

• This form has been revised based on feedback and to better reflect the evidence requirements proposed in the revised approach to site licensing. The form clearly outlines the type of documents that must be submitted to the NNHPD and the type of documents that the applicant is obligated to maintain.

"Good Manufacturing Practices (GMP) Guidance Document":

• This document has been updated to clearly and concisely describe how to be compliant with Part 3 of the Natural Health Product Regulations (NHPR). In addition to changes made to provide more clarity on the intent of various sections of the NHPR, a new sub-section has been added to outline the types of documentation that are acceptable as evidence for various parts of the GMP requirements. Several new appendices have also been added to provide additional guidance.

Site licensing pilot

The site licensing pilot includes enhancements to the current process as well as the introduction of an independent on-site GMP audit component, which allows manufacturers, packagers, labellers and importers to elect to undergo an independent, on-site audit to demonstrate compliance with the GMP standards.

The pilot will help inform Health Canada on the appropriate level of oversight needed and whether a voluntary third-party model for on-site GMP audits is appropriate for assessing GMP compliance of NHP sites. It will also provide Health Canada with a better sense of the current state of GMP compliance.

The one-year pilot will start in the fall of 2014 once the final versions of the "Revised Approach to NHP Site Licensing", "Good Manufacturing Practices" and "Site Licensing" guidance documents are finalized and posted.

Compliance and Enforcement - End of Phase 2

In preparation for the end of the compliance transition period, Health Canada will complete revisions to the "NHP Compliance and Enforcement Policy (POL-0044)". The HPFB Inspectorate will continue to apply its risk-based approach to non-compliance, while developing its infrastructure and tools, to support a gradual increase of pro-active activities, including compliance monitoring.

Advisory Bodies

The NNHPD has examined the governance and structure of a new expert advisory body that would capture the scope of CHPs now within the Directorate's purview. It is currently developing a notice to stakeholders regarding this new approach, and it will be posted by the fall of 2014.

Non-prescription Drug Monograph Attestation Pilot

As a key advance in aligning appropriate oversight and leveraging operational advances made in the NHP review area, the NNHPD launched a six-month Non-prescription Drug Monograph Attestation Pilot in the summer of 2014. The standard of evidence will not change as many non-prescription drug products are already supported by high quality monographs.

During the six-month pilot, non-prescription drug products supported entirely by one of the following eight (8) monographs will be able to attest to the high standards previously established by Health Canada: Sunscreen Monograph - Version 2.0 (2013), Acne Therapy (2006), Anti-Dandruff Products (2006), Antiseptic Skin Cleansers (2006), Athletes Foot Treatments (1995), Medicated Skin Care Products (2007), Diaper Rash Products (2007) and Throat lozenges (1995).

For the duration of the pilot, the NNHPD will audit the process and follow up with companies as appropriate. After six (6) months, the overall success of the pilot will be evaluated 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.

Plain Language Labelling Initiative

Under the Plain Language Labelling Initiative, the NNHPD is involved in developing and revising the labelling guidance for industry. Consultation with external stakeholders on this new guidance is for late 2014/early 2015.

New Monographs

• Aromatherapy
• Aloe vera leaf gel oral
• African Wild Mango (Irvingia gabonensis)
• Kutki (Picrorhiza kurrooa)
• Uva ursi
• Olive leaf
• DIM (3,3'-Methylenebis-1H-indole)
• Indole-3-carbinol (3-Hydroxymethylindole)
• Slippery elm (Ulmus rubra)
• Betaine/betaine hydrochloride
• Elderberry (Sambucus nigra)
• Chlorella
• Pygeum (Prunus africana)
• Oregano essential oil
• Soyabean flour
• Fungal products

Updates to existing monographs

• Update to the Oil Products, Multiple Ingredients
• Update to the Dong quai Monograph
• Update to the Goldenseal Monographs
• Update and combine 1) Hard Surface Disinfectants Monograph and 2) Toilet Bowl Disinfectant Cleansers Monograph
• Update to the Antiseptic Skin Cleansers Monograph
• Update to the Topical Anaesthetic/Analgesic/Antipruritic Labelling Standard

The NNHPD will be examining a new approach to monograph development. This may include updates to existing monographs beyond those listed above, based on publicly-available information submitted in product licence applications.

2.0 Final Publications

• The final version of the "Management of Product Licence Applications (PLAs) for Natural Health Products" was posted following a 60-day consultation.
• The final version of "Data Requirements for Switching Medicinal Ingredients from Prescription to Non-prescription Status" was posted following a 75-day consultation.

3.0 Workshops and meetings

Ongoing bilateral meetings with the following stakeholder associations:

• Consumer Health Products Canada, Canadian Health Food Association, Canadian Homeopathic Pharmaceutical Association, Canadian Natural Products Association, Canadian Cosmetic, Toiletry and Fragrance Association, Canadian Consumer Specialty Products Association, Direct Sellers Association, La Guilde des herboristes, and Traditional Chinese Medicine Community.
• Meeting of the Advisory Council on Traditional Chinese Medicine (AC-TCM).

4.0 Update from previous calendar

• The on-site audit pilot of NHP manufacturers, packagers, labellers and importers is now scheduled to start in the fall of 2014 to allow for the finalization and posting of the "Revised Approach to NHP Site Licensing", "Good Manufacturing Practices" and "Site Licensing" guidance documents.
• The NNPHD will continue to work on developing a single-window approach for disinfectant products.
• The NNHPD continues to focus on redefining the class system to expand Classes I and II. This effort will result in a greater transparency between Classes II and III; thus ensuring predictability in timelines.