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The S.T.E.P.S plan
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(PDF Version - 40 Kb)Health Canada's Natural Health Products Directorate's (NHPD) multi-pronged strategic plan for addressing the current product licence application backlog by March 31, 2010 and achieving a normal workload environment for the assessment and licensing of natural health products (NHPs).
Standardized Claims for Natural Health Products (NHPs) and Pre-Cleared Information (PCI).
Recognizing the key role monographs and other standards can and have played in facilitating the licensing of a broad range of NHPs, the NHPD is developing a list pre-cleared information sources (PCI) that can be attested to by applicants to support the safety and efficacy of certain types of NHPs without the need for further assessment.
PCI includes domestic and international standards, monographs, pharmacopoeias as well as standardized claims the NHPD is presently developing to allow for a number of generalized health claims to facilitate market access for a broad range of NHPs.
Benefits
- Quick and easy licensing of NHPs with a documented history of safe and effective use.
- Generalized claims open up market access to a wide range of single and multi-ingredient NHPs that otherwise may not be licensed for sale.
- Ensures regulatory oversight proportional to risk (i.e. assessment focussed on products where safety and efficacy not supported by PCI).
Transparency and Openness is a vital component in NHPD's ability to regulate NHPs effectively and accountably with the support and cooperation of its stakeholders. In this regard, the NHPD has:
- Made available information on licensed NHPs through the Licensed Natural Health Products Database.
- Instituted a formal Reconsideration Process for regulatory decisions.
- Issued quarterly reports on the NHPD's progress in assessing and licensing product and site licence applications.
Upcoming initiatives:
- Posting records of decisions online.
- Expanding bilateral meeting program to other stakeholder groups
- Site Licence Holders Database
Electronic Solutions, such as the Natural Health Products Online System and the Natural Health Products Ingredients Database will revolutionize the way in which applicants prepare and submit licence applications to Health Canada.
Benefits
- Electronic "fillable" forms enable applicants to complete licence applications directly from their computers.
- Ability to send applications securely and electronically directly to the NHPD, saving time, money and paper.
- Fields in the form can be pre-populated with accurate NHP ingredient information at the touch of a button.
- Built-in fail-safes and crosschecks ensure that a high quality, error-free application is sent to the NHPD.
Process Improvements are critical components that must be included for proper NHP application assessment within specific performance targets.
Over the past few years, a number of measures have been implemented continue to be put in place to strengthen the efficiency of the review process.
Highlights and Upcoming Work
- Product Licence Application (PLA) completion rate increased seven fold (up to 700 per month) and the product licensing rate doubled in 2008 (over 10,800 product licences have been issued since 2004)
- New streamlined process for non-traditional applications has enabled the NHPD to complete the initial assessment of over 7000 non-traditional PLA since May 2008.
Service Delivery is the key area that supports the other S.T.E.P.S components, and involves the relationships between Health Canada and its international and domestic stakeholders.
Highlights and Upcoming Work
- Training workshops and sessions with key stakeholders to further facilitate understanding of and compliance with the Regulations.
- Education and awareness efforts to begin targeting consumers of NHPs.
- Development of assessment standards for product licence applications.
- Updates to the NHPD website to provide accurate and useful information on the regulation of NHPs.
