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Health Canada builds monograph resources for industry

By Clarisse Douaud , 25-Apr-2007

Canada's Natural Health Products Directorate (NHPD) has issued new ingredient monographs for Ashwagandha and revised ingredient monographs for Blessed Thistle and 'Heal-All', as part of the government's efforts to compile authoritative reference material for both industry and consumers.

According to Health Canada, monographs are created for very common and popular substances and products that have a well recorded, documented or consistent history of safe and effective use for certain purposes.



However, other monographs are also developed by NHPD in response to the increased use of specific ingredients or new scientific developments surrounding them.



The NHPD identifies ingredients such as Ashwagandha - a popular herb in the Indian Ayurvedic tradition of medicine - and then compiles the reference from a variety of sources.



"… the NHPD's Monograph Development Unit is tasked with the development of new monographs and revision of current monographs," Health Canada spokesperson Renee Bergeron told NutraIngredients-USA. "They are in charge of the entire process, including required research analysis and review and the drafting of the monographs."



The NHPD has an external expert advisory committee on natural health products at its disposal. As such it can consult with experts and professionals in a number of fields for a proposed monograph.



Bergeron also said the NHPD sometimes chooses to compile monographs based on suggestions from industry. NHPD gets the wheels in motion for an ingredient if "an increasing number of people are seeking authorization for a specific ingredient for a specific purpose," according to Bergeron.



The monographs are then changed in keep with regulations or new information, as was this case with herbals Blessed Thistle and 'Heal All'.



"Modifications were made to the common names, uses of the product and risk information," said Bergeron.



Industry use monographs for their product licence applications, according to the agency.




"This facilitates the review and assessment of the application and those applications citing a monograph (known as 'compendial' applications) are processed the quickest (within 60 days)," said Bergeron.



Consumers can also access the monographs for information on safety, risks and uses.