Commonwealth Numbered Regulations - Explanatory Statements

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THERAPEUTIC GOODS REGULATIONS (AMENDMENT) 1992 NO. 370

STATUTORY RULES 1992 No. 370

Issued by Authority of the Minister for Aged, Family and Health Services

Therapeutic Goods Act 1989

Therapeutic Goods Regulations (Amendment)

The Therapeutic Goods Act 1989 (the Act) has for its objective the establishment and maintenance of a national system of controls relating to the quality, safety, efficacy and timely availability of therapeutic goods that are used in Australia or exported from Australia.

Sections 17, 18, 26, and 34 of the Act relevantly provide that the Governor-General may make regulations, not inconsistent with the Act, in respect of the following matters:

(a)       paragraph 17(4)(a) - prescribing the therapeutic goods to be included in the relevant part of the Australian Register of Therapeutic Goods (the Register) designed for registrable or listable goods;

(b)       subsection 18(1) - prescribing therapeutic goods that may be exempted from the requirement to be included in the Register;

(c)       paragraph 26(1)(g) - prescribing imported therapeutic devices that are to be subject to scrutiny in respect of their manufacturing and quality control procedures, for the purposes of determining their suitability for inclusion in the Register; and

(d)       subsection 34(1) - prescribing the therapeutic goods that are to be exempt from the requirement to be manufactured under licence for the purposes of Part 4 of the Act.

The proposed Regulations effect changes to the Schedules of the Therapeutic Goods Regulations to add new items to, or to clarify the operation of or the meaning of the various provisions or Items contained in those Schedules.

In summary, the Regulations:

(a)       clarify that certain critical accessories (such as administration sets) to powered drug infusion systems are required to be registered in the Register if supplied separately;

(b)       correct errors in punctuation in Item 3(g) of Schedule 3 and add a further group of devices of animal origin to the exemptions from this item;

(c)       clarify what kind of implantable breast prostheses require a higher degree of evaluation to establish suitability for inclusion in the Register, and those tissue expanders that need not be registered in the Register;

(d)       add certain devices that are barriers and are indicated for use for contraception or for prevention of the transmission of disease in the course of penile penetration during sexual intercourse, in the list of Items required to be registered in the Register;

(e)       exempt from the requirement for registration or listing, certain types of human tissue used for implantation in humans. Tissue banking technology has rapidly established itself in Australia and this amendment is to bring institutions supplying such goods within the regulatory framework. The Department of Health, Housing and Community services is currently working with tissue banking facilities to develop an acceptable code of Good Manufacturing Practice. In the interim, for supply of these vital products to be allowed, it is necessary to exempt them from the requirement to be included in the Register. This approach parallels that taken in the United States of America;

(f)       clarify Schedule 5, Item 7 (n) by making it clear that in addition to non-absorbent applicators, absorbent applicators for use with inhalations are also exempt from the requirement to be listed in the Register;

(g)       clarify the intention behind Item 3 of Schedule 6 and Item 4 of Schedule 7 of the regulations by drawing a distinction between materials used for the restoration of teeth and other implantable devices.

Further details of the Regulations are set out in the Attachment.

The Regulations commence on gazettal.

ATTACHMENT

DETAILS OF THE THERAPEUTIC GOODS REGULATIONS (AMENDMENT)

Subregulation 2.1 has the effect of requiring accessories for powered drug infusion systems which regulate the flow of infusate to be registered in the Register.

Subregulation 2.2 has the effect of removing an ambiguity caused by misplaced punctuation in the sentence following paragraph 3(g). The amendment would make it clear that devices of human or animal origin for use in or on the body of a person, are registrable goods unless they fall within the descriptions set out in subparagraphs (i) to (vi) of Item 3.

Subregulation 2.3 has the effect of exempting devices that "incorporate gelatine which conforms to generally accepted pharmacopoeial standards" from the requirement to be registered in the Register. Instead, such goods need only be listed in the Register, and would not need to be evaluated to the same extent as registrable goods under section 25 of the Act.

Subregulation 2.4 has the effect of requiring only those implantable breast prostheses which contain material of fluid consistency, other than water or saline solution, to be subjected to a higher level of evaluation. This means in the main implantable breast prostheses filled with silicone or other gels.

Subregulation 2.5 has the effect of:

(a)       making implantable breast prostheses that are filled with only water or saline solutions registrable, but subject to a lower level of evaluation than similar goods that are filled with silicone or other gels. Saline and water filled implantable breast prostheses have a lower level of risk of injury and are therefore subjected to a less detailed evaluation;

(b)       exempting mammary tissue expanders, that are filled with water or saline solution and that are not intended by the manufacturer to be left permanently in place, from the requirement to be registered in the Register. This means that mammary tissue expanders of this type will be regulated as listable goods;

(c)       requiring all therapeutic devices that act as a barrier and that are indicated for contraception or for prevention of transmission of disease in the course of penile penetration during sexual intercourse, other than rubber diaphragms and rubber condoms that conform to a standard under part 2 of the Act, to be registered in the Register. Such goods, which include 'female condoms' and condoms made of materials other than rubber, will thus be subject to some evaluation of their quality, safety, and efficacy, and the costs of this evaluation will be recovered from the sponsor. Once standards are developed for these goods under Part 2 of the Act, they will become listable goods.

Subregulation 3.1 has the effect of clarifying that "absorbent applicators for use with inhalations" are included within the existing exemption in Item 7(n). These goods were always intended to be exempted from the requirement to be included in the Register.

Subregulation 3.2 has the effect of adding a new Item 7(q) in Schedule 5 to exempt from the requirement for registration or listing, human tissue for implantation including skin, bone, heart valves, cartilage, tendon, and cornea, that are obtained, stored and supplied without any deliberate alteration to its biological or mechanical properties by institutions whose procedures for obtaining, storing and supplying such goods comply with manufacturing principles determined under subsection 36(1) of the Act.

Subregulations 4.1 and 4.2 have the effect of separating materials for restoration of teeth and implantable therapeutic devices into two items in Item 3, Schedule 6 - (b) and (g). This will clarify that both groups are prescribed for the purposes of paragraph 26(1)(g) of the Act. The change does not alter the substance of the Schedule in any way.

Subregulations 5.1 and 5.2 have a similar effect on Schedule 7 Item 4, by separating materials for the restoration of teeth and implantable therapeutic devices into two items. Again the change is for clarity only and does not alter the substance of the Items contained in that Schedule.