Purpose of the Cost Recovery Implementation Statement (CRIS)

This CRIS provides information on how the Therapeutic Goods Administration (TGA) implements cost recovery of activities associated with the manufacture of medicines. TGA regulates manufacturers through application of Good Manufacturing Practice (GMP) principles. This CRIS also reports financial and non-financial performance information and contains financial forecasts for 2015-16. The TGA will maintain the CRIS until the activity or cost recovery for the activity has been discontinued.

Description of the activity

The TGA forms a part of the Department of Health and is responsible for evaluating the safety, quality and efficacy of medicines, medical devices and biologicals available for supply in, or export from Australia.

The TGA approves and regulates products based on an assessment of risks against benefits. All therapeutic goods carry potential risks, some of which are minor, some potentially serious. The TGA applies scientific and clinical expertise to its decision-making to ensure that the benefits of a product outweigh any risk. The level of TGA regulatory control increases with the level of risk the medicine or device can pose. The risk-benefit approach assures consumers that the products they take are safe for their intended use, while still providing access to products that are essential to their health needs.

In Australia, manufacturers of therapeutic goods are required to hold a licence, except for manufacturers of certain medical devices who have European conformity certification (CE Mark). To obtain the licence, a manufacturer must demonstrate that they have the ability to comply with manufacturing principles, which include relevant Codes of GMP and Quality Systems, and have appropriate facilities to manufacture safely. Overseas manufacturers of therapeutic goods supplied to Australia must provide evidence of compliance with equivalent GMP standards or otherwise undergo on-site inspections in the same manner as manufacturers based in Australia.

GMP is a generally accepted term internationally to describe a set of principles and procedures that, when followed by manufacturers of medicines and biologicals, helps insure that the products manufactured will possess the required quality.

Outputs and business processes of the activity

The GMP related regulatory activities undertaken are as follows:

Licensing

TGA usually undertakes on-site inspections of Australian manufacturers prior to the issue of a licence to ensure that the manufacturer can comply with the manufacturing principles set under the Therapeutic Goods Act 1989 (the Act) and has suitable premises to undertake the proposed manufacturing steps. The extent of the inspection depends on the size and complexity of the manufacturing processes.

The TGA participates in international harmonisation activities to ensure that GMP requirements applied in Australia are best practice.

Monitoring compliance

The TGA undertakes periodic planned and unplanned inspections of manufacturers to assess the level of compliance with the applicable manufacturing standards, both domestically and overseas. The level and frequency of inspections for a particular manufacturer is influenced by its size and complexity but also by its compliance history. In particular, manufacturers with a history of lower levels of compliance are subject to a higher frequency of on-site inspections, compared with more compliant manufacturers, to ensure that therapeutic goods supplied in Australia are of appropriate quality and to allow TGA to take appropriate regulatory action where safety concerns are identified.

Investigation and enforcement

The TGA undertakes appropriate actions to promote and ensure compliance with the applicable GMP standards by manufacturers. Where a licensed Australian manufacturer poses unacceptable safety or quality risks, sanctions available range from (but are not limited to) revocation or suspension of the manufacturing licence to restriction of the type, kind or quantity of goods that can be manufactured for the Australian market at that site. Where required, sanctions are decided on a case-by-case basis after consideration of the circumstances involved and the best interests of the Australian consumer. Where the manufacturer is based outside Australia, limits are placed on the ability of sponsors to make the products available on the Australian market.

Information and education

The TGA promotes compliance with the manufacturing standards by producing guidelines and other informational materials primarily targeted at manufacturers whose products are supplied in Australia. These resources are made available through the TGA website. In addition, the TGA conducts seminars and information briefings to raise awareness of regulatory requirements, particularly when changes are proposed.

TGA contributes strongly to international programs to improve and harmonise manufacturing practices in developing regions through international meetings, seminars and training events.

Policy development and services to government

The TGA provides services to Government in relation to the regulation of manufacturers, including specific technical and policy advice that is considered to be integral to the regulation of manufacturers.

Broader policy advice is generally provided by the Department of Health as part of its taxpayer funded activities and is not included in the fees and charges.