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Regulatory change: How the TGA legislation and guidelines are amended

21 June 2013

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TGA legislation and guidelines

Overview

The TGA is responsible for administering:

  • Primary legislation
    • the Therapeutic Goods Act 1989 (the TGAct)
    • the Therapeutic Goods (Charges) Act 1989 (the Charges Act)
  • Delegated or subordinate legislation
    • the Therapeutic Goods Regulations 1990
    • the Therapeutic Goods (Charges) Regulations 1990
    • the Therapeutic Goods (Medical Devices) Regulations 2002.

The TG Act also provides for the making, by the Minister or the Secretary, of a range of legislative instruments, such as Therapeutic Goods Orders, which determine standards for therapeutic goods.

Changes to the TG Act, the regulations or existing legislative instruments, or the making of new legislative instruments, may be needed from time to time for a number of reasons, including to:

  • support or implement reform initiatives
  • increase transparency
  • effect annual increases to TGA fees and charges
  • correct errors or remove inconsistencies
  • maintain the currency of the legislation with regards to new developments in the therapeutic goods industry.

The TGA also maintains a number of guidelines documents intended to assist applicants, sponsors and manufacturers to comply with, and better understand, the legislation and their obligations under it.

The information set out in this document is intended to provide an overview of how the TG Act, the regulations and legislative instruments are amended (or, in the case of legislative instruments other than the regulations, how new such instruments are made), and to provide an idea of the timeframes that may apply for such measures.

This guide does not focus on the consultation processes that will in most cases be undertaken by the TGA in relation to proposals to significantly amend the legislation or to introduce significant new or amended legislative instruments.

This guide also does not focus on best practice regulation requirements (including completing Regulation Impact Statements). It is, however, important to note that these steps will need to be addressed at an early stage of the development of legislative change or the preparation of legislative instruments.

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