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Fees and charges: summary from 1 July 2019

Version 1.1, July 2019

25 July 2019

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Clinical trials

The Clinical Trial Notification (CTN) and Clinical Trial Exemption (CTX) schemes provide two avenues for conducting clinical trials involving the use of unapproved therapeutic goods.

Unapproved medicines

These fees for clinical trials of unapproved medicines.

Table 70: Unapproved medicines
Unapproved medicines Fee Schedule 9 Part 2
Clinical trial notification (CTN) $370 Item 14(a)
Clinical trial notification (CTN) - for each notification of one or more additional trial sites $370 Item 14(b)
Clinical trial exemption (CTX) - 30 day evaluation $1,760 Item 1(a)
Clinical trial exemption (CTX) - 50 day evaluation $21,900 Item 1(b)

These fees are in Schedule 9, Therapeutic Goods Regulations 1990

Unapproved biologicals

These fees for clinical trials of unapproved biologicals.

Table 71: Unapproved biologicals
Biologicals Fee Schedule 9A Part 2
Clinical trial notification (CTN) $370 Item 17(a)
Clinical trial notification (CTN) - for each notification of one or more additional trial sites $370 Item 17(b)
Clinical trial exemption (CTX) $26,600 Item 16

These fees are in Schedule 9A, Therapeutic Goods Regulations 1990

Unapproved medical devices (including IVDs)

These fees for clinical trials of unapproved medical devices and IVDs.

Table 72: Unapproved medical devices (including IVDs)
Unapproved medical devices (including IVD) Fee Schedule 5 Part 1
Clinical trial notification (CTN) $370 Item 1.8
Clinical trial exemption (CTX) $18,600 Item 1.7

These fees are in the Therapeutic Goods (Medical Devices) Regulations 2002

Unapproved other therapeutic goods

These fees for clinical trials of unapproved other therapeutic goods.

Table 73: Unapproved other therapeutic goods
Unapproved other therapeutic goods Fee Schedule 9 Part 2
Clinical trial notification (CTN) $370 Item 14A(a)
Clinical trial notification (CTN) - for each notification of one or more additional trial sites $370 Item 14A(b)
Clinical trial exemption (CTX) - with no clinical studies to demonstrate safety and effectiveness $2,800 Item 1(d)
Clinical trial exemption (CTX) - with clinical studies to demonstrate safety and effectiveness $18,600 Item 1(c)

These fees are in Schedule 9, Therapeutic Goods Regulations 1990

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