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CMEC Meeting 01, 16-17 December 1997

Complementary Medicines Evaluation Committee

16 December 1997

Extracted ratified minutes

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CMEC Meeting 1 extracted ratified minutes (pdf,35kb)

Public recommendation summary

Item 2.1 Consideration of the draft paper prepared by TGA titled 'Arrangements for Complementary Medicines and Related Matters'

The proposed Schedule 14 would be included in the regulations to provide a definition of complementary medicines. This would not change the current registrable and listable categories of therapeutic goods included on the ARTG. Changes were to be made to Schedule 10 to enable areas other than DSEB to evaluate new substances and certain products. The scheme set out on the Draft Guidelines is being refined and in consultation with industry and amendments to the legislation are expected to be introduced early in 1998.

CMEC noted the Guideline titled 'Arrangements for Complementary Medicines and Related Matters' with suggested amendments.

Item 3.1 An application form for new complementary medicine substances and guidelines for submitting data

The current published TGA application forms and guidelines are product-oriented whereas the regulation of complementary medicines includes a mechanism for identifying new substances that may be included in low risk products listed for supply in Australia. A complementary medicine containing a substance not so identified is registrable. An application form and guidelines for making applications for new complementary medicine substances is required. Sponsors wishing to make these applications need, inter alia, to provide a clear explanation of the level of evidence accompanying applications.

The draft application form and guidelines will be sent to industry associations and consultants for comment.


CMEC agreed in principle to support the use of the application forms and guidelines as outlined in the agenda paper.

Item 3.2 Public consultation for general matters

There is no statutory obligation for TGA to undertake public consultation, but where possible, the TGA would like to take advantage of public consultation in its decision making processes for complementary medicines. A consultation process feeding into the Committee's deliberations would be in keeping with the recommendations of the 1996 TGA Review on greater stakeholder involvement in the regulatory process and the Government's acceptance in principle of this recommendation.

Members would provide advice to TGA as soon as possible on individuals and organisations who could be consulted on complementary medicine matters.


Members endorsed the proposed public consultation process for issues before CMEC.

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Item 3.3 Process for considering the safety of herbal ingredients

The current method of identifying low risk herbal ingredients is not fully effective and, as a consequence, some products and ingredients escape appropriate safety evaluation and others are subjected to unnecessarily rigorous safety evaluation.

This regulatory problem may be addressed by changing the wording of the definition of "herbal substance" and the way in which that definition is applied in the Therapeutic Goods Regulations. Members were invited to provide TGA with details of people and organisations that TGA should consult in relation to this matter.


  1. To support the proposed changes to the Therapeutic Goods Regulations.
  2. Members would consult with appropriate people and organisations on this recommendation.
  3. The matter be considered at the next meeting.
  4. To undertake a progressive safety review of herbal substances in products currently included in the ARTG.
  5. To the establishment of a Working Party chaired by Dr Myers with Professor Ahokas and Ms Johanson as members, to consider priorities for the review of herbs and to report to the next meeting.

Item 4.1 Guidelines for stability testing of herbal products

On July 25 1996 a joint meeting of the TMEC Working Group, industry representatives and the TGA considered draft guidelines for stability testing and the industry groups response. Following this meeting the guidelines were redrafted, in conjunction with the industry groups and the TMEC Working Group resulting in the current draft document dated 20 January 1997. At the 25 July 1996 meeting it was agreed that the redrafted guidelines be forwarded to the industry for review and comment but to date this has not taken place.


CMEC endorsed the proposal to circulate the draft guidelines widely to sponsors of herbal products.

Item 5.1 Royal jelly - safety review

In the light of the 19 reports, including 3 deaths to the Adverse Drug Reactions Advisory Committee related to the ingestion of royal jelly, and given the Government's responsibility to protect public health and safety, and in accordance with the object and requirements of the Therapeutic Goods Act 1989, in relation to safety, quality and efficacy, the Parliamentary Secretary and the TGA sought advice from the Complementary Medicines Evaluation Committee (CMEC).

Declaration of conflict of interest

Two members declared a conflict of interest: Dr Stephen Myers declared he had prepared the literature search for the Nutritional Foods Association of Australia (NFAA) and had been paid for the search. The Members agreed to permit Dr Myers to take part in discussion and to participate in any vote. Ms Val Johanson declared her role in the preparation of the NFAA submission which was to request the author to reformat the submission. The Members agreed that Ms Johanson could take part in the discussion but could not vote if voting on the issues were required.


CMEC agreed to:

  1. Permit royal jelly to be included in listable products, provided:
    • the labelling of the products includes the current warning which is:
      This product contains royal jelly which has been reported to cause severe allergic reactions and in rare cases, fatalities, especially in asthma and allergy sufferers;
    • the products are not promoted for any condition which might be a symptom of an allergic or hypersensitivity condition eg hay fever, rhinitis or asthma; and
    • the products are not promoted for children and the labelling includes a warning specifying that the product is not suitable for children.
    • CMEC made the recommendation for the following reasons:
      • the current warning together with the additional warnings are adequate to protect public health and safety;
      • by limiting the claims which can be made, the risk/potential benefit ratio is improved; and
      • more quality control will be achieved than at present.
  2. Develop a specific standard for royal jelly as a therapeutic good.
    • CMEC made the recommendation for the following reasons:
      • it seems likely that some of the products marketed as royal jelly could be worker jelly;
      • royal jelly appears to be relatively unstable and therefore the quality of royal jelly products is likely to be variable;
      • from the available information, royal jelly products on the market could be adulterated or contaminated; and
      • it would ensure royal jelly products on the market do not contain allergens such as pollen.
  3. A possible wording of the new warning statement to appear on the label will be developed with further input from CMEC members.
    • CMEC made the recommendation for the following reasons:
      • the message needed to be more direct; and
      • while the potential for adverse reactions is not confined to asthma and allergy sufferers the message should be particularly directed to them.
    • Note:
      • that there is potential for a fatal reaction: and
      • any requirement for a new label warning would be made with a suitable lead-in period.
  4. A section 7 declaration be made under the Therapeutic Goods Act 1989 to declare royal jelly presented in capsules, phials and powders, to be therapeutic goods.
    • CMEC made the recommendations for the following reasons:
      • the contribution to nutritional requirements of capsules, phials and powders does not justify nutrition being considered a principle role for these goods; and
      • there is a widely held community perception that royal jelly has therapeutic benefit.
    • The proposed section 7 declaration has implications for the regulation of royal jelly as a food and could mean that Standard K2 Honey and Related Products, which includes provisions for royal jelly in the Food Standards Code should be amended to exclude royal jelly in the forms recognised as therapeutic goods.

Item 6.1 TGA draft herbal standard

The European Pharmacopoeia (EP) is actively involved in the elaboration of a general monograph for Herbal Drugs.

The view of the Therapeutic Goods Committee is that the TGA should continue to support the development of the European Pharmacopoeia general standard for herbals, rather than creating a standard just for Australia. The microbial limits is of particular interest to the TGA and is under active discussion between the TGA, EP and the US Food and Drug Administration.


Members noted this item.

Item 7.1 Update on External Reference Panel on Therapeutic Goods/Food Interface Matters - definitions of "therapeutic goods" and "foods" - for information


Members noted this item.

Item 9 Next meeting

The next meeting of CMEC will be held on Wednesday 11 February 1997.

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