Regulatory reforms proposed for complementary medicines
Consultation on regulatory reforms for the complementary medicines sector - Wednesday 30 July 2008
Discussion on key reform areas
General agreement was reached to progress the regulatory reforms proposed in the key areas listed below and separately set out in the common areas for reform. Specific matters for this product sector are outlined below.
Matters raised were addressed by a TGA panel comprising:
| TGA | |
|---|---|
| Dr Rohan Hammett | National Manager, TGA |
| Mr Charles Maskell-Knight | Principal Adviser, Regulatory Reform |
| Mr Pio Cesarin | Head, Office of Non-Prescription Medicines |
| TGA Office of Complementary Medicines (OCM) | |
| Prof David Briggs | Head, Office of Complementary Medicines |
| Ms Michelle McLaughlan | Director, Pre-Market Assessment Section |
| Ms Libby Kerr | Director, Listed Medicines and Communications Section |
| TGA Executive Support Unit | |
| Mr Michael O'Connor | Director, Parliamentary and Regulatory Operations Section |
| Mr Michael Wiseman | Director, Strategy and External Relations Section |
Participants were asked to note this would be the final public consultation on the proposed reforms except where otherwise indicated.
Readers are encouraged to read this document in conjunction with the reforms common across all therapeutic product sectors <http://www.tga.gov.au/regreform/common.htm> and with the presentation for this sector <http://www.tga.gov.au/regreform/common.htm#pres>.
1. Legislative amendments deferred in anticipation of the Joint Regulatory Scheme
Administrative amendments
Administrative amendments are proposed to the Therapeutic Goods Act for listed medicines mandating existing practice of delegate-imposed conditions in relation to various listing conditions and certifications for complementary medicines.
It is expected that the proposed legislative amendments would be introduced in the autumn 2009 sitting of the Australian Parliament.
Compositional monographs
Participants were advised that statutory monographs would replace the existing system of compositional guidelines. This would be a long-term project involving both replacement of existing Guidelines with Monographs and the writing or sourcing of new Monographs where no Guidelines currently exist. In both cases there will be consultation on the Monograph, as already occurs with the Guidelines.
Homoeopathic and anthroposophic preparations
Participants noted that the regulatory framework for these preparations recognised the need to remain true to type within each paradigm and clearly set out the critical elements to be met for each paradigm. This was expected to assist in eliminating unjustified claims and excluding un-validated ingredients. The proposed reforms are being finalised and will be subject to further stakeholder consultation. Please see: Regulation of homoeopathic and anthroposophic medicines in Australia <http://www.tga.gov.au/cm/conshomoeo.htm>
It is expected that the proposed legislative amendments would be introduced in the autumn 2009 sitting of the Australian Parliament.
Expert Advisory Committee on Complementary Medicines
The membership of the Complementary Medicines Evaluation Committee <http://www.tga.gov.au/docs/html/cmec/cmec.htm> will be expanded to include expertise in the manufacture of complementary medicines and in epidemiology.
Definitions
Participants noted the proposal to implement the revised definition for "complementary medicine" developed as part of ANZTPA. Participants were advised that there had been no adverse comments received in previous consultation and that necessary legislative changes were expected to be introduced in the autumn 2009 sitting of the Australian Parliament.
Participants also sought further information regarding "essences" and "herbal substances". They were informed that these would be addressed at a later date and will be subject to further stakeholder consultation.
2. Opportunities for reducing regulatory burden
Therapeutic goods orders
Participants were informed that the revised Therapeutic Goods Order (TGO) for tablets and for capsules proposes a range of limits for the content of active ingredients in listed medicines depending on the nature and stability of the ingredient. It also seeks to harmonise requirements with international standards. Additionally it was noted that the TGA would revise the groups order with regards to listed medicines. Some participants expressed a desire that these TGOs be implemented as soon as possible.
Participants noted that the Order was expected to be finalised before the end of 2008 followed by a two-year transition period to the new standards. The need for a transition period had been considered during the ANZTPA consultations.
GMP for active starting materials in Listed medicines
Consistent with risk, and following stakeholder consultation, it is proposed to exempt the manufacture of starting materials for use in listed medicines from the requirement to be manufactured under GMP where the sole therapeutic purpose of the material is as a starting material for use by a medicine manufacturer.
Other issues are covered in common reforms <http://www.tga.gov.au/regreform/common.htm>.
3. Increasing transparency and the access to information
These issues are covered in common reforms <http://www.tga.gov.au/regreform/common.htm>.
4. Enhancements to post-market monitoring
These issues are also covered in common reforms <http://www.tga.gov.au/regreform/common.htm>.
The broader remit of the proposed Medicines Safety Committee in relation to this sector was highlighted. Much of the fine detail remained to be resolved for complementary medicines including reporting timeframes, record retention and reporting requirements.
5. Future directions
Levels of evidence required to support indications and claims
Participants noted the proposal to provide legal underpinning to the "levels of evidence" guideline. Progress has been made in reviewing the existing Guidelines for the Levels and Kinds of Evidence Required to Support Indications and Claims <http://www.tga.gov.au/docs/html/tgaccevi.htm> for listed complementary medicines to allow this to occur. Proposed changes to the evidentiary requirements for Listed medicines will be subject to stakeholder consultation.
Participants also noted that the proposed Weight Loss Guidelines are also expected to be released for public consultation shortly following completion of an internal review processes.
It is expected that the legislative changes required to underpin the levels and kind of evidence to support indications and claims for listed complementary medicines will be introduced into the autumn 2009 sitting of the Australian Parliament.
National Prescribing Service study
Participants were aware that the National Prescribing Service (NPS) is currently undertaking a study into the complementary-medicine information uses and needs of consumers and health professionals. It was noted that the results from the NPS research should be available in the near future which would inform the TGA on the way forward in this area.
Presentation
Presentation 30 July 2008: Regulatory reforms proposed for complementary medicines (pdf,264kb)
**These presentation papers are provided on the TGA's website solely for the purpose of indicating or suggesting what TGA representatives spoke about to the various conferences and seminars to which they relate. The papers are not legislative in nature and should not be taken to be statements of any law or policy in any way.
The Australian Government Department of Health and Ageing (of which the TGA is a division) advises that (a) the presentation papers should not be relied upon in any way as representing a comprehensive description of regulatory requirements, and (b) cannot guarantee, and assumes no legal liability or responsibility for, the accuracy, currency or completeness of the information contained in the presentation papers.**