Statutory committees are defined as those established through an Act of Parliament or by Regulations. The TGA's statutory committees are comprised mainly of external expert members who are appointed by the Minister for Health to provide critical specialist advice to the TGA's delegated decision makers. In addition, experts in consumer and patient issues on committees also provide valuable advice from the viewpoint of users of medicines, devices or other products that the TGA regulates. Under the Therapeutic Goods Regulations 1990, these individuals provide advice to delegates of the Secretary of Health to assist them in carrying out decisions.

Proposed statutory committees

Efficiencies will be achieved through reducing the number of statutory advisory committees that provide independent expert advice to the TGA. The previous eleven advisory committees have now been replaced by seven committees to provide advice on specific clinical and scientific matters to aid regulatory decision making, in particular on applications for the market approval of new products and safety issues relating to particular products or product groups. The following statutory committees have been established or maintained:

1. Advisory Committee for Medicines (ACM). The new ACM covers:
   1. the market authorisation advice role of the current Advisory Committee on Prescription Medicines;
   2. medicines safety advisory role of the current Advisory Committee on the Safety of Medicines; and
   3. providing advice as required on issues relating to over-the-counter medicines (currently carried out by Advisory Committee on Non-Prescription Medicines).
2. Advisory Committee on Complementary Medicines (ACCM).
3. Advisory Committee for Medical Devices (ACMD). The new ACMD covers:
   1. the market authorisation advice role of the previous Advisory Committee on Medical Devices
   2. the devices safety advisory role of the previous Advisory Committee on the Safety of Medical Devices.
4. Advisory Committee for Vaccines (ACV).
5. Advisory Committee for Biologicals (ACB).
6. Advisory Committee on Chemicals Scheduling (ACCS).
7. Advisory Committee on Medicines Scheduling (ACMS).

An expert 'core' of membership for each committee is drawn from clinical, scientific, industry and consumer groups. This new structure will maintain the same functions providing greater efficiency while not compromising the TGA's decision making on safety, quality and efficacy.

With the increasing specialisation of certain new medicines, medical devices and cell and tissue therapies, additional expert advisors will attend particular meetings to provide specific advice to decision making delegates.

We are anticipating that these committees will be asked for advice earlier in the regulatory evaluation process. In particular, for novel medicines and devices, for products subject to expedited or provisional approval and for those products where initial analysis of the data raises potential safety concerns.

Appointment and funding arrangements

The first five committees listed above will continue to be funded through TGA cost recovery arrangements. The Advisory Committees on Chemicals Scheduling and Medicines Scheduling will continue to be funded through departmental appropriations because the primary remit of these committees is to advise on a series of state and territory controls on the access to substances used in medicines and chemicals for the purpose of public health, rather than to support market approvals for particular products. These committees review substances and not products. As these substances are usually found in multiple products and industries, to recover costs from an individual applicant or supplier could unfairly advantage other users of the substance.

Establishment of the new committees have required changes to both the Therapeutic Goods Regulations 1990 and the Therapeutic Goods Act 1989.

An advertising and recruitment process to fill all positions on the new committees was undertaken late 2016 to enable the committees to be in place for 2017. The previous committee appointments had concluded at the end of 2016.

All committee appointments were made by the Health Minister with the exception of the Advisory Committees for Chemicals Scheduling and Medicines Scheduling. These two committees are comprised of state and territory nominees as well as independent experts appointed by the Minister. This is because medicines and chemicals scheduling decisions by the Commonwealth are implemented through state and territory legislation.

Other sources of stakeholder advice

The TGA Consultative Committee (TCC), formerly the TGA Industry Consultative Committee, provides a consultative forum for industry and non-industry peak bodies at the highest level. Together with the Consumers Health Forum, TCC provides direct feedback to the TGA on broad policy, resource allocation and program performance issues.

Bilateral meetings will also be held with industry representatives each year and a number of other forums will be maintained.