The document outlines regulatory guidelines for validating traditional medicines through preclinical and clinical studies. It discusses the types of information required in investigational new drug applications (INDs) for botanical drug products, including descriptions of the botanical ingredients, manufacturing and quality controls, pharmacology, toxicity studies, and previous human experience. The level of information required increases from initial clinical trials to expanded clinical trials and approaches for new drug applications (NDAs). Preclinical studies help identify compounds likely to be safe and effective in humans, while clinical trials progress from small initial safety studies to larger efficacy trials.

1. REGULATORY GUIDELINES FOR PRECLINICAL AND CLINICAL VALIDATION OF TRADITIONAL MEDICINES Dr. Basavaraj K. Nanjawade Associate Professor of Pharmaceutics Department of Pharmacology JN Medical College Belgaum-10 e-mail: [email_address] BY

8. "Natural Products" platform

14. Regulatory Approaches FOR MARKETING BOTANICAL DRUG PRODUCTS

15. INFORMATION TO BE PROVIDED IN AN IND FOR A BOTANICAL DRUG IND for a Botanical Drug Product General principles; format and contents (slid No. 16) Initial clinical trial of a marketed botanical product with no known safety issues (Slid No. 17) Initial clinical trial of a nonmarketed botanical product or marketed botanical product with known safety issues (Slid No. 19) Expanded clinical Trial of any botanical product (Slid No. 22) Documentation of use limited CMC information; previous human experience may be sufficient to support safety More documentation of use and more CMC information (Slid No. 17) Same documentation of use but more detailed CMC information; standard nonclinical toxicology studies may be needed (Slid 19) Is the product a traditional preparation? Previous human experience may be sufficient to support safety (Slid. No 19) If the product is marketed only outside the U.S. additional CMC and nonclinical safety information may be needed (Slid. No. 17) Additional nonclinical safety information may be needed (Slid No. 19) No Yes

26. The New Drug Development Process

28. Traditional IND

34. Conclusions of Exploratory IND

35. Conclusions of Exploratory IND

36. NDA Process

37. Generic Drug (ANDA)Process

38. OTC Drug Monograph Process

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