Challenges in the Authorization of Clinical Trials Involving Botanicals

Clinical trials involving natural health products (NHPs) in Canada fall under the jurisdiction of the Natural Health Products Regulations [1]. Plant identification is one of the most problematic issues observed during our assessment of >260 clinical trial authorization applications involving NHPs (e.g., Black Cohosh misidentification [2]). Botanicals and their extracts have more than one active constituent, and clinical trials may involve multiple botanicals, e.g., for Traditional Chinese Medicine, making assessment of identity, purity, potency, safety and likelihood of efficacy even more complex. Although guidance is provided [3], other regulatory challenges encountered include insufficient data for chemical contaminants (specifically heavy metals, solvent residues, pesticides, and mycotoxins), data to support the stability of the medicinal ingredients or finished products throughout the trial period, proprietary manufacturing information, potential for interactions and adverse reactions. Acknowledgements: Thanks go to our colleagues in the Clinical Trials Division, Natural Health Products Directorate, Health Canada. References: [1] Government of Canada (2009) Natural Health Products Regulations http://laws.justice.gc.ca/en/showtdm/cr/SOR-2003–196//? showtoc=&instrumentnumber=SOR-2003–196. [2] Marles R, et al. (2008) NHPRS Meeting, Toronto. [3] Health Canada (2007) Natural Health Products Guidance Documents http://www.hc-sc.gc.ca/dhp-mps/prodnatur/legislation/docs/index-eng.php.