Commonwealth Numbered Regulations - Explanatory Statements

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THERAPEUTIC GOODS AMENDMENT REGULATIONS 2002 (NO. 2) 2002 NO. 114

STATUTORY RULES 2002 No. 114

Issued by the authority of the Parliamentary Secretary to the Minister for Health and Ageing

Therapeutic Goods Act 1989

Therapeutic Goods Amendment Regulations 2002 (No. 2).

The object of the Therapeutic Goods Act 1989 (the Act) is to establish and maintain a system of controls for the quality, safety, efficacy and timely availability of therapeutic goods that are used in Australia or exported from Australia. The Therapeutic Goods Administration (the TGA) is responsible for administering the Act.

Section 63 of the Act provides that the Governor-General may make regulations required or permitted to be prescribed by the Act, or that are necessary or convenient to be prescribed for carrying out or giving effect to the Act.

The purpose of the Regulations is to require particular implantable therapeutic devices to undergo comprehensive evaluation of quality, safety and efficacy by the TGA in order to be registered under the Act and therefore allowed to be supplied in Australia and also make other technical amendments.

The implantable therapeutic devices to be registered are those that (a) incorporate an ancillary medicinal substance; or (b) are designed to incorporate an ancillary substance, if the purpose of the incorporation in both instances is to enhance the function of the device.

Under the current regulatory regime these types of therapeutic devices are regulated as listable devices. Consistent with the requirements under the Act for listable goods (section 26 of the Act), only issues of quality and safety are questioned, and clinical efficacy is not evaluated, unlike the case for registrable goods. The Regulations ensure that these therapeutic devices are required to undergo comprehensive evaluation of quality, safety and efficacy by the TGA before they are approved for registration. That is, the pre-market review of these therapeutic devices includes an assessment of whether the potential added risks posed by exposure to the medicinal substances are justified in relation to the benefit obtained from incorporating the substance with the device. This approach was endorsed by the Therapeutic Device Evaluation Committee, a committee established under the Regulations to, among other things, give advice to the Minister or Secretary in respect of the safety, quality, efficacy, manufacture, use and availability of therapeutic devices supplied within Australia.

Details of the Regulations are set out in the Attachment.

The Regulations commenced on gazettal.

ATTACHMENT

Therapeutic Good Amendment Regulations 2002 (No 2).

Regulation 1 provides for the Regulations to be referred to as the Therapeutic Goods Amendment Regulations 2002 (No. 2).

Regulation 2 provides for the Regulations to commence on gazettal.

Regulation 3 provides for Schedule 1 to amend the Therapeutic Goods Regulations 1990.

SCHEDULE 1 - Amendments to the Therapeutic Goods Regulations 1990.

Item 1

Item 1 omits the phrase "active implantable medical devices" and inserts the phrase "active implantable therapeutic devices" in Schedule 3, Part 1, item 4 of the Therapeutic Goods Regulations 1990 (the Regulations). This proposed amendment would ensure consistency in the use of defined terms in the Regulations.

Item 2

Item 2 inserts the definition of particular implantable therapeutic devices in Schedule 3, Part 1 after item 4 with the effect that these devices will now be included in the part of the Australian Register for Therapeutic Goods (ARTG) for registered goods. The classes of devices which are within the scope of this proposed amendment are implantable therapeutic devices that:

(b) incorporate an ancillary medicinal substance; or

(b) are designed to incorporate an ancillary medicinal substance

if the purpose of the incorporation is to enhance the function of the device.

From the commencement of Item 2, implantable therapeutic devices as described above will be required to undergo comprehensive evaluation of quality, safety and efficacy by the Therapeutic Goods Administration before they are allowed to be supplied in Australia. Item 2 is intended to include implantable therapeutic devices wherein the incorporation of the medicinal substance directly or indirectly enhances the function of the device.

Under the current regulatory regime, many implantable medical devices that incorporate ancillary medicinal substances (such as coronary artery stents coated with medicines) are regulated as listable devices. In this case, only issues of safety are questioned and clinical efficacy is not evaluated. This is because section 26 of the Therapeutic Goods Act 1989 (the Act) does not include "efficacy" as a criterion for refusing to list therapeutic goods, unlike the case for registrable goods (see s.25(d) of the Act).

In the case of coronary artery stents, a number of anti-cancer and anti-rejection medicines have been used to coat the stents to reduce restenosis rates and, thus, improve the performance of the device. These medicinal substances are inherently quite toxic and are normally regulated as prescription medicines.

Item 2 has the effect of allowing the pre-market review of these devices to include an assessment of whether the potential added risks posed by exposure to the medicinal substance are justified in relation to the benefit obtained from incorporating the substance with the device.

Item 3

Item 3 omits the phrase "item 3 or 4 of Part 1" and inserts the phrase "item 3, 4 or 5 of Part 1" in Schedule 4, Part 1, Item 2, paragraph (a) of the Regulations. This amendment will ensure that particular therapeutic devices within a class as described in new item 5 of Schedule 3, Part 1 to the Regulations are registrable goods and are no longer required to be included in the part of the ARTG as listed goods as a consequence of Item 2.