The Brazilian Health Regulatory Agency, ANVISA, published answers to questions received during a webinar on clinical research with medicinal Cannabis held in May this year. The 20-pages Q&A document covers general and specific topics, like, for example, importation of cannabis products, simplified authorization procedures for education and research institutions, conducting of cannabis studies, and using of real-life data.
Q&As relating to Batch Reproducibility
One of the important questions addressed is: How can batch reproducibility be demonstrated?
Question: How is the evaluation of the reproducibility of a herbal drug done, so that different batches are considered equal to the product investigated during clinical development? Or is the evaluation done only by the analytical markers defined in legislation / compendia (e.g., thinking of situations of composition variation between different crops or strains)? Answer: The evaluation of the reproducibility of a herbal drug covers several factors that need to be controlled and discussed in the application for registration as a drug, including Good Agricultural and Collecting Practices (GACP), processing, Good Manufacturing Practices (GMP) of the raw material and the drug, extraction method, and quality control characteristics of the raw material and the drug, such as chromatographic profile, qualitative and quantitative markers, possible contaminants, etc., in order to ensure reproducibility.
Question: The same genotype, planted in different conditions, can generate raw material with different concentrations of selected markers (= chemotypes). How does ANVISA see this particularity in the registration of herbal medicines? Answer: This is a challenge for those who work with herbal medicines and herbal raw materials. Standardization should be made in compliance with GACP, processing, GMP of the raw material and the drug, and analysis of the raw material and finished product in order to demonstrate that the variations do not impact the chromatographic profile and concentration of selected markers. If differences in concentrations and profile are present this is a different product and the data or API cannot be used.