Background

The Therapeutic Goods Administration (TGA) will soon have a new framework for the regulation of biological therapy products. A new Bill making a number of amendments to the Therapeutic Goods Act 1989 (Cth)1 (Therapeutic Goods Act) relating to the regulation of biologicals was passed by the Senate on 13 May 2010. The TGA has 12 months within which to implement the new framework once the Bill has received Royal Assent.

The aim of the new legislation, as stated in the explanatory memorandum to the Bill, is to regulate human cellular and tissue-based therapies. Such therapies are currently regulated as either medicines or therapeutic devices under the Therapeutic Goods Act. There is a trend internationally to regulate these goods separately from other therapeutic goods and the regulatory framework provided in the Bill is aimed at providing such a separate regulation of human cell and tissue-based products.

Definition and classification of biologicals

The Bill defines a biological as follows:

  1. Subject to subsection (3) a biological is a thing that:

a.ether:

  1. comprises, contains or is derived from human cells or human tissues; or
  2. is specified under subsection (2); and

b.is represented in any way to be, or is, whether because of the way in which it is presented or for any other reason likely to be taken to be:

  1. for use in the treatment of prevention of disease, ailment, defect or injury affecting persons; or
  2. for use in making a medical diagnosis of the condition of a person; or
  3. for use in influencing, inhibiting or modifying a physiological process in persons; or
  4. for use in testing the susceptibility of persons to a disease or ailment; or
  5. for use in the replacement or modification of parts of the anatomy in persons.

 

  1. The Secretary may, by legislative instrument, specify things for the purposes of subparagraph (1)(a)(ii).

NOTE: For specification by class, see subsection 13(3) of the Legislative Instruments Act 2003.

  1. The Secretary may, by legislative instrument, determine that a specified thing is not a biological for the purposes of this Act.

NOTE: For specification by class, see subsection 13(3) of the Legislative Instruments Act 2003.

On its face, the inclusion of the phrase ‘is derived from’ in subparagraph (1)(a)(i) could potentially include therapeutics that are not themselves cells or tissues, but are rather therapeutics extracted from such cells or tissues. However, there is no indication that the term ‘biological’ for the purpose of these legislative provisions would be interpreted as including actives isolated from cells or tissues, for example in the situation of a cell or tissue culture that produces a recombinant protein therapeutic.

The Bill also provides for the classification of biologicals. Currently, four classes of biologicals have been proposed, depending on the degree of manipulation that has been applied to the cells or tissues: Class 1 being the least processed or manipulated (considered low risk) and Class 4 having undergone the most extensive manipulation of the biological properties of the cells or tissues (considered higher risk). A different level of regulation will be applied to each class, including compliance with manufacturing principles, safety, efficacy and quality. On meeting the requirements for the particular class, the cell or tissue will be entered on the Australian Register of Therapeutic Goods (ARTG).

Exceptions to the regulatory requirements

It is proposed that there will be exemptions from the regulatory requirements for single surgical procedure performed on one patient (autologous transplant) or two patients (non-autologous or allotransplant). The Bill also provides for the approval for importing, exporting or supplying a biological that is not on the ARTG for ‘special and experimental uses’.

Transitional provisions

A three-year transition period from the date of implementation of the biologicals regulation framework is proposed for all currently supplied biologicals to meet the new regulatory requirements.