1. Issues on Chinese Herbal Medicines Chinese Medicine Industry Council of Australia Ltd Max Ma 16 Feb 2010

2. Major Issues on Chinese Herbal Medicines Abuse/Misuse issues Regulatory issues Listable substances issues Solutions

3. Abuse / Misuse Issues – Restrictions CHM substances used outside TCM eg. Mahuang – weight loss Overdosed Prolonged period of usage Single herbs rather than compound formula Unprepared /unprocessed herbs Not fits in the right conditions - all these are not the fault of CHM, but matters of Practitioner expertise Inappropriate self-administration usage Poor management of adverse events Lack of knowledge of CHM by manufacturing industry

4. Regulatory Issues Efficacy is not a primary concern for listed products Tends to use modern medicine’s concept/tools /criteria to assess TCM/CHM CHM standard: BP can not cover CHM eg. Disintegration for honey pills / raw herb identification “ Evidence ” relevance, quality and perception 1. Single concentrated Hong Hua (Carthamus flower) extract to be injected to pregnant rats does not necessarily apply to human, esp. via oral administration or compound formula. 2. Must consider the right of male and non pregnant women to use it as blood stasis removal herbs 3. A range of herbs to be avoided in use for pregnant women have already been in practice by qualified practitioners for ages.

5. Listable Substances Issues Some substances (Important to TCM) restricted in listed medicines Ma Huang (Ephedra spp): ephedrine less than 0.001% for listing – approx. 1/100 th of the therapeutic dose; SUSDP Xing Ren/Tao Ren/Wu Mei /Yu Li Ren (Prunus spp.) – Amygdalin (Hydrocyanic acid) for therapeutic use (appendix C, SUSDP) HCA- less than 0.0000001% Fu Zi /Wu Tou (Aconitum Spp): aconitine to aconine if well prepared and 1/2000 less toxic. SUSDP Ban Bian Lian (Lobelia chinensis) : Lobelia inflata S2,SUSDP Bing Lang (Areca catechu): Arecoline 10mg/kg SUSDP

6. Listable Substances Issues Kuan Dong Hua (Tussilago farfara): D1, S4 Huo Ma Ren (Cannabis sativa seeds): Cannabis D1, S4 Tian Nan Xing/Dan Nan Xing (Arisaema spp.) D1,S4 Shi Chang Pu (Acorus tatarinowii): A. calamus D1,S4 Ku Lian Pi (Melia azedarach): Appendix C, SUSDP V.S Chuan Lian Zi (Melia toosendan Seeds) Luo Bu Ma Ye (Apocynum spp) - SUSDP

7. Solutions on restricted substances Objective & Principle To ensure the safety while efficacy should be balanced Joint review /amendment via TCM/CHM sub-committees Listable/Supply for TCM Practitioners use only with No Indications allowed or indications in TCM terminology only Dose control: must develop an appropriate dose for ARTG listing eg. Prepared Fuzi 3-15g/day (CP) - 3g Max. (AUS) Arisaema (Tian Nan Xing prepared): 3-9g(CP) – 3g max (AUS) prunus amenniaca (xing ren): 4.5-9g/day(CP) – 5g max.(AUS) rather than equiv.1mg dry herb (D2,S4) or HCA 0.001ppm (ELF 2.6) Must be prepared / processed where needed Mandatory warning on label

8. Thank You Happy Chinese New Year!