Preclinical studies for botanical drug substances and drug products with thoursands of unknown ingredients
pharmacological studies
pharmacodynamic studies
safety pharmacology
pharmacokinetics
repeated dose toxicity studies
content characterization
Scaling up GMP manufacturing processes for botanical APIs, drug substances, and drug product
Botanical raw material procurement
U.S. FDA regulatory services and product & clinical development for botanical drugs
FDA Botanical Drug Guidance
The FDA's Botanical Drug Development Guidance, first issued in 2004 and updated in 2016, offers a simplified regulatory pathway for botanical drug products derived from plants. This streamlined approach waives the traditional requirements to identify specific active ingredients and elucidate their mechanisms of action.
Instead, the focus is on demonstrating the safety and efficacy of the entire botanical product through rigorous clinical trials (Phases I, II, and III). Once these trials are successfully completed, the botanical drug can be approved for prescription use in the US market.
Currently, over 700 botanical drugs are undergoing clinical trials under FDA's Investigational New Drug (IND) process.
Botanical Drug IND Pathway
Modern herbal medicines, particularly those formulated as pills or capsules and supported by extensive historical real-world clinical experience, are ideal candidates for botanical drug development in the U.S. prescription market. By leveraging herbal medicines with well-established safety and efficacy profiles in international markets, pharmaceutical companies can potentially reduce the risks, time, and costs associated with drug discovery and development.
While the number of approved botanical drugs is currently limited, the FDA's Botanical Drug Development Guidance for Industry provides clear and actionable directions for conducting botanical INDs. The limited number of approved botanical drug products more related to following factors:
The concept of "botanical drugs" is still relatively new, and there has been insufficient investment in this area.
The guidance has only recently gained broader industry recognization, and developing a drug product is a lengthy process, often exceeding a decade. Numerous botanical drug candidates are currently in FDA IND process.
Botanical drug APIs are the full-spectrum extractions from plants. This poses a challenge for chemists who are more experienced with single-molecule drug development.
The FDA's Botanical Guidance offers a clear pathway for transforming herbal medicines into prescription botanical drugs, unlocking new opportunities for innovation and growth in the prescription drug market.
Extensive expertise in U.S. FDA regulatory services and clinical development of drug products containing plant-derived active pharmaceutical ingredients (APIs), with a particular focus on Chemistry, Manufacturing, and Controls (CMC) aspects.
Extensive experience in U.S. FDA regulatory services and clinical development of drug products containing plant-derived active pharmaceutical ingredients (APIs).
U.S. FDA GMP manufacturing services for botanical active pharmaceutical ingredients (APIs), botanical drug substances, and botanical drug products.
