Extensive experience and abundant clinical data have been accumulated in traditional Korean medicine for thousands of years. Basic and clinical research in traditional Korean medicine (TKM) constitutes a potentially rich source for drug discovery and development. How can we use the information of TKM for the development of new drug? The strategy of botanical new drug development from TKM will be presented by Dr. Kim. Strategy of new phytomedicine development have been derived based upon various experinces of preclinical and clinical develpments in industry, Dong-A Pharm, and will be presented by Dr. Son. Research studies in all fields of medicine are known as clinical trials. These studies are conducted with an eye to the future, in hopes of finding safer or more effective methods to screen for, prevent, diagnose, or treat a variety of diseases. However, botanical new drug approval process is little bit simpler for the approval by the national regulatory authority. Therefore strategic approach for clinical trials for natural Products reduces time and cost of Clinical trials for botanical new drug and dietary supplement which will be presented by Dr. Chae.

Functional Botanical Food New opportunities emerge for traditional Chinese medicine (TCM) based botanical drug as pharmaceutical industries are faced with challenges of increasing costs, time and risk in new drug development. The market trend and sourcing strategy of functional botanical food will be presented by Dr. Kim. In Dr. Guo's presentation, the overall strategies and regulatory considerations for the development of a modernized TCM product will be discussed, using Cardiotonic pills from Tasly as an example. Germany harbors a large number of phytomedicine companies of which Dr. Willmar Schwabe is the largest one, nationally and world-wide. An example for a successful herbal medicinal product (HMP) developed by Schwabe is the Ginkgo biloba extract EGb 761® for the treatment of dementia, peripheral arterial occlusive disease, tinnitus and vertigo. Extensive research is done to identify the active components of medicinal plants and to find the most suitable way to extract them. To establish safety and efficacy, pharmacological, toxicological and clinical studies (phases I-IV) have to be conducted. Standards of evidence-based medicine and controlled clinical trials which fulfill the criteria of GCP have also become the gold standard for evaluating the efficacy of HMP. Finally, phytomedicines are manufactured according to GMP requirements. As a result, doctors and patients in Germany have much more trust in HMP than they have in other countries, where these products are regulated as dietary supplements. In particularly, phytomedicines are seen as safer alternatives to synthetic drugs in many indications.

This session review the efficacy and safety of natural new drugs, herbal medicinal products according to Regulation of the Efficacy and Safety Evaluation of Drugs, etc at KFDA. Herbal medicinal products are distinctly different from conventional medicines in origin of herbal plants, structure, components of herbal medicinal products, physicochemical and phytochemical properties, standardization and specification of drugs. Chemistry, manufacturing and quality control of drugs should be considered first and important in new drug development. There are several regulatory affairs as KFDA notifications to provide information to help product license applicants determine the evidence required to support the quality. This presentation will also analyze changing environment from industry, regulatory, and scientific perspectives. The number of new functional ingredients for dietary supplements has been increased since the enactment of Health/Functional Food Act in 2004. Among them, botanical supplements have limited history of safe use as foods and need special consideration in the respect of safety evaluation. The regulatory perspectives on the evaluation of botanical supplements will be presented by Dr. Kwon at KFDA.

Chair : Hyeong Kyu LEE, Professor/Director, Univ. of Science and Tech. & Natural Medicine Research Center