Calls for common rules on botanicals
extracts in the US, Europe and Canada at the industry's first
integrative medicine and natural healthcare exhibition this month.
Calls heard for a common set of guideline across the world.
Speaking at the event, Edward Croom, the scientific and regulatory consultant for the botanical extracts firm Indena USA, echoed a view held by many in the industry.
"It would be highly desirable to obtain a common set of rules applicable on a world-wide basis: this would allow the consumer to benefit from easier access to products of certified quality, safety, and benefit,".
Highlighting at the same time that harmonisation would be very difficult to achieve due to differences in legislation, tradition and culture.
Croom asserts that the first 'achievable step' should be the definition and adoption of higher common quality standards for botanical drug products. Quality would be better guaranteed by the implementation of rules similar to pharmaceutical GMPs, he said.
The EU has recently signed a substantial amendment to the directive (2001/83/EC) on 'medicinal products for human use'. Under the new rules, phytochemical data should be submitted, as for any other medicinal product, while the safety and efficacy data are waived on the basis of 30 years of 'safe usage' - at least 15 years in one European country.
Dr Croom went on to illustrate US guidance for botanical drug products, which is divided into three main areas: food, dietary supplements, cosmetics ; over the counter drug products ; prescription only drug products.
According to US legislation, quality standards are determined by the food GMP(Good Manufacturing Practices) and proposed dietary supplements GMP.
Botanical drug products, which have been on the market since 1994, may be deemed safe unless they are proven to present significant risk, unreasonable risk, or an imminent hazard. As for the benefits of the product, the FDA claims that the label must accurately state what is in the bottle.
There is no guidance on any evidence required to substantiate label claims regarding either the structure or function.
The FDA recently proposed guidelines that would grant currently marketed dietary supplements easier access to phase I and II clinical trials without pre-clinical data support.
"This should lead to easier acquisition of proven scientific data on safety and efficacy. On the other hand, dietary supplements destined for registration as pharmaceutical products must be supported by complete chemical-toxicological data in order to access phase III clinical trials and qualify for a New Drug Application (NDA)," said Dr. Croom.
"The overall goal must remain to establish adequate standards for quality, safety and benefit," he concluded.
