CMEC 35 Complementary Medicines Evaluation Committee

` CMEC 35 Complementary Medicines Evaluation Committee Extracted Ratified Minutes Thirty Fifth Meeting 14 June 2002 Abbreviations: ADEC Australian Drug Evaluation Committee ADRAC Adverse Drug Reactions Advisory Committee ADRU Adverse Drug Reactions Unit (of TGA) ANZFA Australia New Zealand Food Authority AQIS Australian Quarantine Inspection Service ARTG Australian Register of Therapeutic Goods ASMI Australian Self Medication Industry BP British Pharmacopoeia BSE Bovine spongiform encephalopathy CHC Complementary Healthcare Council of Australia CK Creatine kinase CPK Creatine phosphokinase CMEC Complementary Medicines Evaluation Committee DSEB Drug Safety and Evaluation Branch ELF Electronic Lodgement Facility EP European Pharmacopoeia GRB Geographical Risk of BSE JHTF Joint TGA/Industry Herbal Task Force MEC Medicines Evaluation Committee NDPSC National Drugs and Poisons Schedule Committee OCM Office of Complementary Medicines PBS Pharmaceutical Benefits Scheme SUSDP Standard for the Uniform Scheduling of Drugs and Poisons TGA Therapeutic Goods Administration TGAL Therapeutic Goods Administration Laboratory Branch TSE Transmissible spongiform encephalopathies The thirty fifth meeting of the Complementary Medicines Evaluation Committee was held at the Kingsford Room, Stamford Hotel Sydney Airport, Sydney between 9:30 am and 3:45 pm on Friday 14 June 2002. Members of CMEC present were: Professor Tony Smith (Chair) Mr Nick Burgess Dr Roberta Chow Dr Colin Duke Dr Joachim Fluhrer Ms Val Johanson Professor Stephen Myers Mr Kevin Ryan Professor Bill Webster Dr Heather Yeatman Present from the TGA were: Dr David Briggs Dr John Hall Dr John McEwen Ms Michelle McLaughlin 1. Procedural Matters 1.1 Opening of Meeting The Chairman opened the meeting at 9:34 am and welcomed members and TGA staff. 1.2 Apologies Members noted that Dr Fiona Cumming was unable to attend the meeting. 1.3 Conflict of Interest Members submitted conflict of interest declarations specific to agenda items for this meeting. 2. Confirmation of Minutes of CMEC 34 (3 May 2002) The minutes of the thirty-fourth meeting of CMEC were accepted unanimously as an accurate record of proceedings, subject to a number of amendments: CMEC – Extracted Ratified Minutes 2 Members made the following recommendation: Recommendation 35.1 CMEC confirms that the draft Minutes of its previous meeting (CMEC 34, 3 May 2002), as amended, are a true and accurate record of that previous meeting. 3. Guidelines on levels and kinds of evidence to support claims for therapeutic goods (Guidelines) 3.1 Update A TGA officer introduced this item and indicated that following a meeting between the CMEC Guidelines Working Party and members of the Complementary Healthcare Council of Australia (CHC) Working Group preparing a sponsor guide to the CMEC Guidelines, CMEC Working Party members were asked to comment on the CHC guide. Comments have now been received from most members of the CMEC Working Party. Some issues arose concerning the interpretation of some of the technical terms that were used in the CMEC Guidelines and clarification of some terminology was suggested. The OCM is collating CMEC Working Party comments on the CHC sponsor guide and will forward these to the CHC working group. In addition, the CMEC Guidelines will be amended to clarify the meaning of some technical terminology. 4. CMEC Working Party on Herbal Medicine Issues CMEC considered a draft of the Stakeholder Consultation Paper Review of the Regulation of Herbal Medicinal Substances. A TGA Officer introduced this item and explained that the Consultation paper last viewed by Members has undergone a number of changes. A professional editor has reviewed the paper and merged the Background paper into the Context paper so there are now three parts rather than four and this has greatly improved the readability of the document. The TGA Officer explained that the discussion document on the Standardisation of Herbal Ingredients has now been included in the Consultation Paper. The Officer indicated that the key aim of the consultation paper is to explore solutions to the problems that have been identified and, if possible identify alternative workable solutions to those suggested in the paper. CMEC Members recalled that following endorsement by the CMEC, the Consultation Paper will be referred to the TGA with a view to releasing the paper for public consultation. Members made the following recommendation to the TGA: Recommendation 35.2 CMEC recommends to the TGA that the consultation paper Review of the Regulation of Herbal Medicinal Substances, as amended, be approved and referred to the TGA. 5. Action Arising from Previous Meetings CMEC – Extracted Ratified Minutes 3 5.1 ADRU review of Waller report on kava adverse reactions In introducing this item, a TGA Officer also tabled a letter published in The Lancet that summarised the international situation in relation to adverse events associated with kava (Piper methysticum) containing medicines. The CMEC was requested to note a report from the Adverse Drug Reactions Unit (ADRU). In reviewing a paper by Professor Donald P. Waller commissioned on behalf of the American Herbal Products Association, it was noted that the paper draws upon only five case histories of adverse hepatic events, out of a total of 26 case reports associated with the use of kava. While the role of kava in producing hepatotoxicity cannot be excluded in the cases examined, in a large number of cases, other causes may be responsible for liver damage. Members noted the current international situation and confirmed the current regulatory status of kava in Australia which was based on cautionary approach and appropriate practitioner and consumer alerts. 5.2 Folic acid A TGA Officer advised Members that the TGA is currently in the process of implementing the CMEC recommendation (Recommendation 30.11, CMEC30, October 2001) in relation to the introduction of a dissolution standard for certain folic acid preparations. Members were asked to recall that following a testing program implemented by the TGA Analytical Laboratories (TGAL) last year, approximately 20% of products in tablet form containing 100 micrograms or more per dosage unit tested failed to meet the USP dissolution test. Following industry consultation seeking to determine the practical implications of implementing dissolution studies, the TGA is currently in the process informing sponsors regarding the requirements to be introduced and when they will come into effect. Ultimately, the TGA intends to amend Therapeutic Goods Order No. 56 General Standard for Tablets, Pills and Capsules to include a requirement for certain folic acid formulations to comply with the dissolution criteria in USP25. A suitable period after the introduction of the requirement, the TGA proposes to undertake a survey of folic acid preparations to determine the extent of compliance in the marketplace. The CMEC noted the proposed action by the TGA. 5.4 Regulation of Azadirachta indica (neem) At CMEC 27 (June 2001), the CMEC recommended to the TGA that cold-pressed neem (Azadirachta indica) seed oil is suitable for use in listable therapeutic goods, provided it is restricted to topical application on the skin only, and that certain other conditions are met. The restriction to topical application and the conditions attached to the recommendation were made having regard to the potential toxicity of neem seed oil. Members had considered that the long history of apparently safe use of the preparation (in this form) overcame the lack of well-documented evidence about dermal absorption of the substance. CMEC – Extracted Ratified Minutes 4 At its February 2002 meeting, the National Drugs and Poisons Scheduling Committee (NDPSC) recommended inclusion of Azadirachta indica and all its extracts and derivatives, for agricultural and veterinary use in Schedule 7 and in Schedule 5 for extracts containing 5% or less of total limonoids for agricultural use of the Standard for the Uniform Scheduling of Drugs and Poisons (SUSDP), on the basis of the NDPSC’s concerns about the potential toxicity of neem. The NDPSC also foreshadowed the inclusion of “Azadirachta indica (neem) or its extracts or its derivatives in preparations for human use” in Appendix C of the SUSDP. Present Discussion: Members were advised that a major function of the NDPSC is to give guidance and bring uniformity to the way substances are regulated by the States and Territories. The actual power to control access to poisons and the conduct of practitioners resides with the States and Territories. Members were advised of the important link between the Listing system and NDPSC decisions, such that if the NDPSC changed a schedule, this has the potential to impact upon Listed products. Scheduled substances may not be used in Listed medicines. There is therefore a direct impact on the substances that the CMEC can recommend as eligible for Listing. With regard to the regulation of Azadirachta indica, consideration of the substance by the NDPSC had occurred following an application to the National Registration Authority for Agricultural and Veterinary Chemicals (NRA) for azadirachtin as an agricultural chemical. Members were informed that items for consideration by the NDPSC are normally published in the Commonwealth Gazette prior to deliberation, for the purpose of public consultation. Concerned parties are invited to make submissions, which are then considered by the NDPSC before a decision is made. Once a decision has been made, those parties who

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