It seems without a doubt that increasing global regulatory requirements for natural health products are here to stay. International bodies such as the NHPD (Canada), FDA (U.S.), EMEA/EFSA (European Union), TGA (Australia) and Health Sciences Authority (Singapore), as well as others, are increasingly requesting clinical evidence as mandatory support for the safety and efficacy of natural health products. In addition, consumers are increasingly indicating a preference for safe, condition specific products with a proven level of efficacy. A clinical trial with sig¬nificant findings not only provides the required evidence establishing the safety and efficacy of a product but also permits product innovation and variety in health claims. This increases available marketing opportunities and allows products and companies to stand out from their competitors.

In instances where clinical data is required to support product licensing, such as the current requirements in Canada, it is essential to coordinate clinical trials early. Data required to support the safety and efficacy (health claims) for new and existing products should be gathered well in advance of compliance deadlines, anticipated refusals or new product launches. Indeed, the time required to conduct a modest six month trial involving fifty subjects would easily encompass twelve to twenty four months taking all regulatory, design, recruitment, experimental and analysis components into account.

A number of measures may be put in place to affordably conduct clinical trails for natural health products. These measures include keeping sample size small, but large enough only to assess statistical significance, keeping health claims specific and using biomarkers or surveys as measures of clinical endpoints. As natural health products are indicated for the general population, trails can be conducted in healthy popula¬tions and costly phase III comparator studies are not appropriate or required. This method eliminates the traditional Phase I through IV requirements as with a phar¬maceutical and focuses only on two components, safety and efficacy. The product design process should also be modified to reflect the new regulatory environment. Product design teams should be composed of individuals with marketing, clinical and regulatory knowledge. This would allow achievable and marketable health claims to be identified and ingredients with a proven history of safety to be chosen thus quickly identifying dead ends, unlikely claims, unsafe ingredients and costly pre-clinical and clinical studies.

A number of programs exist in Canada to assist small and medium size enterprises to conduct research that would allow for product innovation. Perhaps the two most applicable programs are the Scientific Research & Experimental Development (SR&ED) Program through the Canada Revenue Agency and the Industrial Research Assistance Program (IRAP) through the National Research Council. The SR&ED program pro¬vides tax incentives of up to 35% on qualified research expenditures carried out in Canada while the IRAP provides non-repayable contributions to eligible enterprises interested in growing by using technology to commercialize services, products and processes in Canadian and international markets.