New Canadian Natural Health Products Regulations Come Into Force January 1, 2004

(Burlington, ON, August 25, 2003)

The new federal Natural Health Product Regulations, which cover product licensing, site licensing, Good Manufacturing Practices (GMP) and clinical trials rules for NHP manufacturers and importers, were published in the Canada Gazette Part II on June 18, 2003. Most of the new rules come into force January 1st, 2004.

Absent from the published regulations are the Standards of Evidence guideline and the GMP guidance document. Inside sources have stated that agreement has not been reached between the stakeholders involed in the creation of the Standards of Evidence document. Despite release of a working draft of the GMP guideline by the NHP Directorate in December 2001, the final draft is not yet ready for release.

Click on the links below for services that may be of interest to readers attempting to cope with the new regulations.

• Scientific support for the NHP Industry
• Laboratory Services offered by ISI
• When to use a Consultant: An Outsourcing Primer
• Quality Systems for Industry: What's new in ISO 9000
• An Inside Look at HPLC; An analytical tool widely used to characterize NHPs