Fees and charges: summary from 1 July 2020

Version 1.3, November 2020

6 November 2020

The TGA is required to recover its costs for all activities that fall within the scope of the Therapeutic Goods Act 1989, including the TGA's public health responsibilities.

  • A fee is charged for a service, such as a product evaluation.
  • A charge is a form of tax on regulated industry and is applied annually based on a 1 July to 30 June financial year.

Go to:

This guidance is a summary of fees and charges, which are in the Australian therapeutic goods legislation. This is not an exhaustive list.

For a complete list of all fees and charges and the exact legislative wording, please refer directly to the legislation.

Legislation links

Prescription medicines

Version 1.3, November 2020

These fees apply to prescription medicines and other medicines evaluated as prescription medicines.

For clinical trials supplying unapproved medicines, go to Clinical trials.

Annual charges for prescription medicines

Table 1: Annual charges for prescription medicines
Type of prescription medicine Charge Regulation
Biological medicine $7,410

Item 7(1)(b)(i)(ii)(iii)

Item 7(2)(b)(i)(ii)(iii)

Non-biological medicine (chemical entity)- subsection 3-10 of regulation 8 $4,220 Item 8(2)(a)
Non-biological medicine (chemical entity) - otherwise $3,430 Item 8(2)(b)
Provisionally registered biological medicine $16,700 Item 9(1)(a)
Provisionally registered non-biological medicine $13,700 Item 9(1)(b)

These charges are in the Therapeutic Goods (Charges) Regulations 2018

More about chemical entities annual charges

Higher annual charges

Regulation 8 of the Therapeutic Goods (Charges) Regulations 2018 states when the higher annual charge applies for prescription medicine chemical entities.

Briefly, for prescription medicine chemical entities, a higher annual charge applies:

  • whatever the duration or registration, for medicines containing at least one specified active ingredient:
    • thalidomide
    • leflunomide
    • lenalidomide
    • mifepristone
    • clozapine
    • isotretinoin
  • until eight years have passed since registration, following an application for:
    • new chemical entity
    • extension of indications
    • change to intended patient group

Annual charges following applications for other major variations will incur higher or lower charges depending on the parent good, for example:

  • new formulation
  • change of strength
  • new dosage forms
Lower annual charges

The lower annual charge applies for:

  • most generic prescription medicines
  • most prescription medicines that are not biological medicines past the eighth anniversary of an application approval for a:
    • new chemical entity
    • extension of indications

      or

    • change to intended patient group.

Application and evaluation fees for prescription medicines

Standard prescription medicine processes

These applications have both an application fee and an evaluation fee.

Table 2: Standard prescription medicine processes
Prescription Medicine Application Type Application Fee Evaluation Fee Schedule 9, Part 2
New chemical entity* $49,800 $199,500 Item 2(ba) and Item 4(a)
Extension of indications* $29,700 $118,400 Item 2(bd) and Item 4(b)
Major variations*^ $19,400 $77,200 Item 2(bi) and Item 4(g)
Minor variation applications applied for under section 23 of the Act (Change in formulation, composition, design specifications, type of container or change of trade name)^ $1,140 $4,540 Item 2(bj) and Item 4(h)
Variations to an ARTG entry involving the evaluation of clinical, pre-clinical or bio-equivalence data, applied for under 9D(3) of the Act. Includes applications for changes to Product Information involving the evaluation of clinical, pre-clinical or bio-equivalence data*^ $1,140 $4,540 Item 2AC and Item 2C
Additional trade name^ $3,140 $12,500 Item 2(bh) and Item 4(d)
New generic product* $19,200 $76,200 Item 2(bg) and Item 4(c)
Extension of indications of a generic medicine to maintain currency with indications already registered to the corresponding innovator product and where clinical and/or bioequivalence data are not required $1,140 $4,540 Item 2 (bk) and Item 4(bc)

These fees are in Schedule 9, Therapeutic Goods Regulations 1990
'The Act' refers to the Therapeutic Goods Act 1989
n/a: not applicable
* the fees are the same for the standard process and the comparable overseas regulator report-based process
^ the fees are the same for registered and provisionally registered medicines

Priority review pathway for prescription medicines

These applications have both an application fee and an evaluation fee.

Table 3: Priority review pathway for prescription medicines
Prescription Medicine Application Type Application Fee Evaluation Fee Schedule 9, Part 2
Priority determination of a prescription medicine $13,000 n/a Item 1B
New prescription medicine in the priority pathway $52,700 $211,000 Item 2(bca) and Item 4(ab)
New indications medicine in the priority pathway $31,400 $125,500 Item 2(bfa) and Item 4(bd)

These fees are in Schedule 9, Therapeutic Goods Regulations 1990
n/a: not applicable

Provisional approval pathway for prescription medicines

These applications have both an application fee and an evaluation fee.

Table 4: Provisional approval pathway for prescription medicines
Prescription Medicine Application Type Application Fee Evaluation Fee Schedule 9, Part 2
Provisional determination of a prescription medicine $13,000 n/a Item 1AA
Extension of provisional determination $4,700 n/a Item 1AB
Provisional registration of a new prescription medicine $49,900 $260,300 Item 1AC(a) and Item 1AD(a)
Provisional registration of a new indications medicine $29,800 $171,700 Item 1AC(b) and Item 1AD(b)
Extension of provisional registration $17,900 n/a Item 1AG
Transition from provisional registration to full registration* $29,700 $125,200 Item 1AE and Item 1AF

These fees are in Schedule 9, Therapeutic Goods Regulations 1990
n/a: not applicable
* Fees for an application under Section 23 for registration of a medicine that is included in the part of the ARTG for goods known as provisionally registered goods to be included in the part of the ARTG for goods known as registered goods.

Requests with single fee

These requests have a single fee, instead of an application fee and an evaluation fee.

Table 5: Requests with single fee
Prescription medicine request Fee Schedule 9, Part 2
Variations to an ARTG entry, applied for under section 9D(3) of the Act, involving the evaluation of only chemistry, quality control or manufacturing data. Includes applications for changes to Product Information involving the evaluation of only chemistry, quality control or manufacturing information. $5,680 Item 2B
Minor editorial changes: variations to an ARTG entry (requiring changes to Product Information) with no evaluation of data $1,740 Item 2A(a)
Correction to an ARTG entry $1,740 Item 2A(a)
Notification request $830 Item 2CB
Self-assessable request with no evaluation of data $1,740 Item 2A(a)
Safety-related request with no evaluation of data $1,740 Item 2A(a)
Safety-related request with evaluation of data $5,680 Item 2CA
Request for advice in relation to a prescription medicine for the purpose of listing the medicine as a pharmaceutical benefit $2,300 Item 18
Request for early scientific advice on a biowaiver justification $8,570 Item 1ABA
Application for consent by the Secretary under sections 14 and 14A of the Act to the import, export or supply of therapeutic goods that do not comply with an applicable standard where the application relates to a single entry in the register. $490 Item 1A(a)
Application for consent by the Secretary under sections 14 and 14A of the Act to the import, export or supply of therapeutic goods that do not comply with an applicable standard where the application relates to two or more entries in the register.

$490 for the first entry

plus $100 for each additional entry

Item 1A(b)

These fees are in Schedule 9, Therapeutic Goods Regulations 1990
'The Act' refers to the Therapeutic Goods Act 1989

Medicines as components of devices

This table applies to prescription medicines used as an ancillary component of a medical device.

Table 6: Medicines as components of devices
Application type Application fee Evaluation fee Schedule 9, Part 2
New chemical entity of a medicine used as an ancillary medical component of a device - chemistry, quality control and manufacturing OR nonclinical studies $16,500 $66,600

Item 2(bb)

Item 4(aa)(i)

Item 4(aa)(ii)

New chemical entity of a medicine used as an ancillary medical component of a device - chemistry, quality control and manufacturing AND nonclinical studies $33,200 $132,700

Item 2(bc)

Item 4(aa)(iii)

Extension of indicators of a medicine used as an ancillary medical component of a device - chemistry, quality control and manufacturing OR nonclinical studies $9,870 $39,500

Item 2(be)(i)

Item 4(bb)(i)

Item 4(bb)(ii)

Extension of indications of a medicine used as an ancillary medical component of a device - chemistry, quality control and manufacturing AND nonclinical studies $19,900 $78,900

Item 2(bf)(i)

Item 4(bb)(iii)

Major variation of a medicine used as an ancillary medical component of a device - chemistry, quality control and manufacturing OR nonclinical studies $6,440 $25,600

Item 2(be)(ii)

Item 4(bb)(i)(b)

Item 4(bb)(ii)(b)

Major variation of a medicine used as an ancillary medical component of a device - chemistry, quality control and manufacturing AND nonclinical studies $12,900 $51,600

Item 2(bf)(ii)

Item 4(bb)(iii)

These fees are in Schedule 9, Therapeutic Goods Regulations 1990

Non-prescription medicines

Version 1.3, November 2020

Non-prescription medicines include:

  • listed medicines
  • assessed listed medicines
  • registered complementary medicines, and
  • registered over-the-counter (OTC) medicines.

For clinical trials supplying unapproved non-prescription medicines, go to Clinical trials.

Listed medicines

Listed medicines are medicines that are not registered, for example:

For listed export-only medicines go to Export of therapeutic goods.

Listing applications

The following fees and charges apply to medicines listed under section 26A of the Act.

Table 7: Listing applications
Listed medicine fee or charge Amount Regulation
Annual charge $1,160

Therapeutic Goods (Charges) Regulations 2018

Item 7(1)(c)(i) and Item 7(2)(c)(i)

Application fee $860

Therapeutic Goods Regulations 1990,
Schedule 9 Part 2

Item 3(b)

Processing fee (variation to an existing listing) $440

Therapeutic Goods Regulations 1990,
Schedule 9 Part 2

Item 2A(b)

Application for consent by the Secretary under sections 14 and 14A of the Act to the import, export or supply of therapeutic goods that do not comply with an applicable standard where the application relates to a single entry in the register. $490

Therapeutic Goods Regulations 1990,
Schedule 9, Part 2

Item 1A(a)

Application for consent by the Secretary under sections 14 and 14A of the Act to the import, export or supply of therapeutic goods that do not comply with an applicable standard where the application relates to two or more entries in the register.

$490 for the first entry

plus $100 for each additional entry

Therapeutic Goods Regulations 1990,
Schedule 9, Part 2

Item 1A(b)

These fees are in the Therapeutic Goods (Charges) Regulations 2018 and the Therapeutic Goods Regulations 1990
'The Act' refers to the Therapeutic Goods Act 1989.

Permitted indications

Applications for a new permitted indication have an application fee.

Table 8: Permitted indications
Listed medicine fee or charge Amount Schedule 9, Part 2
Application fee for a new indication to be added to the permitted indication list $1,080 Item 7C

These fees are in Schedule 9, Therapeutic Goods Regulations 1990

Permitted ingredients

The ingredient application pathway is available for applications related to ingredients (new or variations) in:

  • listed medicines (under section 26A of the Act)
  • assessed listed medicines (under section 26AE of the Act)

An application to vary the permitted ingredients list has both an application fee and an evaluation fee.

Table 9: Permitted ingredients for listed medicines
Application Category Application fee Evaluation fee Schedule 9, Part 4
IN1 $1,110 $14,900 Item 28 and Item 29
IN2 $1,110 $14,900 Item 30 and Item 31
IN3 $2,940 $24,300 Item 32 and Item 33
IN4 $2,940 $24,300 Item 34 and Item 35

These fees are in Schedule 9, Therapeutic Goods Regulations 1990

Assessed listed medicines

Annual charge for assessed listed medicines

Assessed listed medicines have an annual charge.

Table 10: Annual charge for assessed listed medicines
Annual charge Amount Regulation
Annual charge $1,160

Part 2 Item 7(1)(c)(i)

Part 2 Item 7(2)(c)(i)

These charges are in the Therapeutic Goods (Charges) Regulations 2018

Assessed listed applications

Applications for assessed listed medicines (under section 26AE of the Act) have both an application fee and an evaluation fee.

Table 11: Assessed listed applications
Application Category Application fee Evaluation fee Schedule 9, Part 4
L(A)1 $460 $1,730 Item 22 and Item 23
L(A)2 $1,870 $14,300 Item 24 and Item 25
L(A)3 $1,870 $14,300 Item 26 and Item 27

These fees are in Schedule 9, Therapeutic Goods Regulations 1990

Variations to assessed listed medicines

Table 12: Section 23 applications
Application type Application fee Evaluation fee Schedule 9 Part 4
L(A)CN (section 23) application $810 n/a Item 1F
L(A)C1 (section 23) application $940 $1,090 Item 1D and 1G
L(A)C2 (section 23) application $940 $7,920 Item 1E and 1H

These fees are in the Therapeutic Goods Regulations 1990
n/a: not applicable

Table 13: Section 9D applications
Application type Upfront fee Refund if no evaluation Schedule 9 Part 4
L(A)CN (section 9D) notification request $810 n/a Item 1C
L(A)C1 (section 9D) application $2,030 $1,090 Item 1A, Item 1G
L(A)C2 (section 9D) application $8,860 $7,920 Item 1B, Item 1H

These fees are in the Therapeutic Goods Regulations 1990
n/a: not applicable

Registered complementary medicines

Annual charges for registered complementary medicines

Registered complementary medicines have an annual charge.

Table 14: Annual charges for registered complementary medicines
Charge Amount Regulation
Annual charge $1,520 Item 7(1)(a)(i) and Item7(2)(a)(i)

These charges are in the Therapeutic Goods (Charges) Regulations 2018

Application and evaluation fees for registered complementary medicines

Applications for registered complementary medicines have both an application fee and an evaluation fee.

Table 15: Application and evaluation fees for registered complementary medicines
Application Category Application fee Evaluation fee Schedule 9, Part 4
RCM1 $560 $3,240 Item 12 and Item 13
RCM2 $2,030 $21,700 Item 14 and Item 15
RCM3 $2,030 $21,700 Item 16 and Item 17
RCM4 $2,680 $29,500 Item 18 and Item 19
RCM5 $2,940 $37,600 Item 20 and Item 21

These fees are in Schedule 9, Therapeutic Goods Regulations 1990

Variations to registered complementary medicines

Section 23 applications

For applications to change registered complementary medicines made under section 23 of the Therapeutic Goods Act 1989, there is an application fee and an evaluation fee for RCMC2, RCMC3 and RCMC4 applications.

For information on application types, go to the Australian Regulatory Guidelines for Listed Medicines and Registered Complementary Medicines (ARGLMRCM).

Table 16: Section 23 application to change registered complementary medicines
RCM change application category Application fee Evaluation fee Schedule 9, Part 4
RCMC1 $1,470 n/a Item 5
RCMC2 $770 $4,200 Item 6 and Item 7
RCMC3 $830 $6,570 Item 8 and Item 9
RCMC4 $850 $9,710 Item 10 and Item 11

These fees are in Schedule 9, Therapeutic Goods Regulations 1990
n/a: not applicable

Section 9D applications

For applications to change registered complementary medicines made under section 9D of the Therapeutic Goods Act 1989, there is an application fee and a refund if no evaluation occurs for RCMC2, RCMC3 and RCMC4 applications.

For information on application types, go to the Australian Regulatory Guidelines for Listed Medicines and Registered Complementary Medicines (ARGLMRCM).

Table 17: Section 9D application to change registered complementary medicines
RCM change application category Upfront fee Refund if no evaluation* Regulation
Notification requests $830 n/a

Part 2 Item 2CC

Part 2 Item 2CB

RCMC1 $1,470 n/a Part 4 Item 1
RCMC2 $4,980 $4,200 Part 4 Item 2 and Paragraph 43ACA(2)(a)*
RCMC3 $7,390 $6,570 Part 4 Item 3, and Paragraph 43ACA(2)(b)*
RCMC4 $10,500 $9,710 Part 4 Item 4, and Paragraph 43ACA(2)(c)*

These fees are in Schedule 9, Therapeutic Goods Regulations 1990
* refund amounts are in Division 2 Part 7, Therapeutic Goods Regulations 1990

Other fees

Table 18: Other fees for registered complementary medicines
Type of fee or charge Amount Schedule 9 Part 2
Application for consent by the Secretary under sections 14 and 14A of the Act to the import, export or supply of therapeutic goods that do not comply with an applicable standard $490 Item 1A(a)
Application for consent by the Secretary under sections 14 and 14A of the Act to the import, export or supply of therapeutic goods that do not comply with an applicable standard where the application relates to two or more entries in the register.

$490 for the first entry

plus $100 for each additional entry

Item 1A(b)

These fees are in Schedule 9, Therapeutic Goods Regulations 1990
The 'Act' refers to the Therapeutic Goods Act 1989

Registered OTC medicines

For guidance on OTC applications, go to the Australian regulatory guidelines for OTC medicines.

Annual charges registered OTC medicines

Registered OTC medicines have an annual charge.

Table 19: Annual charges registered OTC medicines
Medicine type Charge Regulation
Registered OTC medicine $1,520 Item 7(1)(a)(i) and Item7(2)(a)(i)

These charges are in Part 2 of the Therapeutic Goods (Charges) Regulations 2018

New registered OTC medicine applications

For information on application types, go to OTC application categorisation framework.

Table 20: New registered OTC medicine applications
Application type Application fee Evaluation fee Schedule 9 Part 3
N1 application $1,680 $4,160 Item 1(a) and Item 2(a)
N1 concurrent application per additional application (as described in item 3, Part 3, Schedule 9 of the Regulations) $850 $4,160 Item 3(d) and Item 2(a)
N2 application $1,680 $5,910 Item 1(b) and Item 2(b)
N2 concurrent application per additional application (as described in item 3 of Part 3 Schedule 9 of the Regulations) $850 $5,910 Item 3(e) and Item 2(b)
N3 application $2,700 $9,100 Item 1(c) and Item 2(c)
N3 concurrent application per additional application (as described in item 3 and 4 of Part 3 Schedule 9 of the Regulations) $1,360 $4,610 Item 3(f) and Item 4(d)
N4 application $3,950 $15,100 Item 1(d) and Item 2(d)
N4 concurrent application per additional application (as described in item 3 and 4 of Part 3 Schedule 9 of the Regulations) $1,360 $4,610 Item 3(g) and Item 4(e)
N5 application $5,850 $22,300 Item 1(e) and Item 2(e)
N5 concurrent application per additional application (as described in item 3 and 4 of Part 3 Schedule 9 of the Regulations) $1,360 $4,610 Item 3(h) and Item 4(f)

These fees are in Schedule 9, Therapeutic Goods Regulations 1990

Section 23 application to change registered OTC medicines

For applications to change registered OTC medicines made under section 23 of the Therapeutic Goods Act 1989, there is an application fee and an evaluation fee for C2, C3 and C4 applications.

For information on application types, go to OTC application categorisation framework.

Table 21: Section 23 application to change registered OTC medicines
Application type Application fee Evaluation fee Schedule 9 Part 3
C1 (section 23) application $1,680 n/a Item 1(f)
C2 (section 23) application $1,680 $4,160 Item 1(g) and Item 2(f)
C3 (section 23) application $1,680 $6,980 Item 1(h) and Item 2(g)
C4 (section 23) application $2,700 $9,100 Item 1(i) and Item 2(h)

These fees are in Schedule 9, Therapeutic Goods Regulations 1990
n/a: not applicable

Section 9D application to change registered OTC medicines

For applications to change registered OTC medicines made under section 9D of the Therapeutic Goods Act 1989, there is a fee and a refund if no evaluation occurs for C2, C3 and C4 applications.

For information on application types, go to OTC application categorisation framework.

Table 22: Section 9D application to change registered OTC medicines
Application type Upfront Fee Refund if no evaluation* Regulation
CN (section 9D) notification request $830 n/a Part 2 Item 2CB and Part 2 Item 2CD
C1 (section 9D) application $1,680 n/a Part 3 Item 5(a)
C2 (section 9D) application $5,850 $4,160 Part 3 Item 5(b) and Paragraph 43AC(2)(a)*
C3 (section 9D) application $8,670 $6,980 Part 3 Item 5(c) and Paragraph 43AC(2)(b)*
C4 (section 9D) application $11,800 $9,100 Part 3 Item 5(d) and Paragraph 43AC(2)(c)*

These fees are in Schedule 9, Therapeutic Goods Regulations 1990
* refund amounts are in Division 2 Part 7, Therapeutic Goods Regulations 1990n/a: not applicable

Other fees for registered OTC medicines

Table 23: Other fees for registered OTC medicines
Registered OTC medicine request Fee Schedule 9 Part 3
Request for advice in relation to a registered OTC medicine for the purpose of listing the medicine as a pharmaceutical benefit that does not contain clinical data $1,650 Item 7(a)
Request for advice in relation to a registered OTC medicine for the purpose of listing the medicine as a pharmaceutical benefit that contains clinical data or a justification as to why such data is not needed $8,470 Item 7(b)
Application for consent by the Secretary under sections 14 and 14A of the Act to the import, export or supply of therapeutic goods that do not comply with an applicable standard where the application relates to a single entry in the register. $490 Item 1A(a)
Application for consent of Secretary to importation into Australia, supply for use in Australia, or exportation from Australia of a medical device that does not conform to the essential principles where the application is for two or more medical devices.

$490 for the first entry

plus $100 for each additional entry

Item 1A(b)

These fees are in Schedule 9, Therapeutic Goods Regulations 1990
The 'Act' refers to the Therapeutic Goods Act 1989.

New substances

This is an old provision from 2005 that remains in the Therapeutic Goods Regulations 1990 at R16GA that is now infrequently used. This pathway is still available for applications for:

  • a new substance in a listed medicine
  • a new substance for registered medicines
  • multiple new excipients in listed or registered medicines for dermal use.

There are evaluation fees, but no application fees for new substance applications.

Table 24: New substances
Pages of nonclinical and clinical data Evaluation fee Schedule 9, Part 2
0-50 $10,900 Item 7A(a), Item 7A(b)(i), Item 7B(a) and Item 7B(b)(i)
51-250 $14,100 Item 7A(b)(ii) and Item 7B(b)(ii)
251-500 $19,200 Item 7A(b)(iii) and Item 7B(b)(iii)
501-1000 $25,400 Item 7A(b)(iv) and Item 7B(b)(iv)
1001-2000 $38,100 Item 7A(b)(v) and Item 7B(b)(v)
2001-3000 $50,800 Item 7A(b)(vi) and Item 7B(b)(iv)
>3000 $76,200 Item 7A(b)(vii) and Item 7B(b)(vii)

These fees are in Schedule 9, Therapeutic Goods Regulations 1990

Manufacturing medicines and OTGs

Version 1.3, November 2020

The section applies to the manufacture of:

Annual charges for manufacturing licences

Manufacturing licences have an annual charge.

Table 25: Annual charges for manufacturing licences
Annual charges for manufacturing licences Charge Regulations
Manufacturing licence charge for medicines, ingredients, components, herbal and homeopathic preparations and containers $4,770 Item 7(5)(a), Item 7(5)(b), Item 7(5)(c) and Item 7(5)(e)

This charge is in the Therapeutic Goods (Charges) Regulations 2018

Manufacturing inspections

Australian manufacturing licences

Applications for Australian manufacturing licences have application, variation and inspection fees.

Table 26: Australian manufacturing licences
Fees related to Australian manufacturing licences Fee Schedule 9 Part 2
Australian manufacturing sites - application fee for a manufacturing licence $810 Item 8(a)
Variation application for a manufacturing licence $810 Item 8A
Australian manufacturing sites - inspection fee $1,010 /hour/inspector Item 9(a)

These fees are in Schedule 9, Therapeutic Goods Regulations 1990

Overseas manufacturing site inspections

There is no application fee for GMP certification of overseas manufacturing sites.

Table 27: Overseas manufacturing site inspections
Overseas manufacturing site inspections Fee Schedule 9 Part 2
Overseas manufacturing sites - inspection fee $1420 /hour/inspector Item 9(b)
Inspection fees to cover costs and reasonable expenses by each inspector, including costs for accommodation and allowance outside Australia Costs and reasonable expenses

These fees are in Schedule 9, Therapeutic Goods Regulations 1990

GMP clearance fees

There is no application fee for GMP clearance. See GMP clearance guidance for information on this process.

Table 28: GMP clearance fees
GMP clearance of overseas manufacturers Fee Schedule 9 Part 2
GMP clearance application processing fee (per manufacturer, per site, per sponsor) $660 Item 6AA
Obtaining evidence from an overseas regulatory authority (per manufacturer, per site, per sponsor) $710 Item 6AB
Compliance verification (in lieu of an overseas GMP inspection) $2,530 Item 6ABA
Reinstatement of expired GMP clearance approval (per manufacturer, per site, per sponsor) - in addition to relevant fees above $1,200 Item 6AC

These fees are in Schedule 9, Therapeutic Goods Regulations 1990

Issuing manufacturing certificates

There are fees for issuing manufacturing certificates.

Table 29: Issuing manufacturing certificates
Certificate Fee
Certificate of GMP compliance $180
Mutual Recognition Agreement certificate $350

Certified copy of:

  • original GMP certificate
  • certificate of GMP compliance
$70

Export of therapeutic goods

Version 1.3, November 2020

This section references the fees and charges associated with export only therapeutic goods and export certification for therapeutic goods.

Export only medicines

There is an application fee and a processing fee for listed export only medicines.

Table 30: Export only listed medicines
Export only applications Fee Schedule 9 Part 2
New export only medicine listing $860 Item 3(b)
Grouping application for an existing export only medicine listing $860 Item 3(b)
Variation application for an existing export only medicine listing $440 Item 2A(b)
Grouping application to add an export name to a registered product $860 Item 3(b)

These fees are in Schedule 9, Therapeutic Goods Regulations 1990

Export certification for medicines

Export certification is provided for medicines that are registered or listed in the Australian Register of Therapeutic Goods (ARTG).

Table 31: Export certification for medicines
Certificate type Fee Schedule 9 Part 2
Certificate of Pharmaceutical Product (CPP) $180 Item 10
Certificate of Listed Product (CLP) $180 Item 10

These fees are in Schedule 9, Therapeutic Goods Regulations 1990

Medical device export certification

Export certification is provided for medical devices, including in-vitro diagnostic medical devices (IVDs) and Other Therapeutic Goods (OTGs).

Table 32: Export certification for medical devices
Certificate type Fee Schedule 9 Part 2
Certificate of Free Sale $180 Item 10
Export Certificate $180 Item 10

These fees are in Schedule 9, Therapeutic Goods Regulations 1990 export only devices

Export only devices

This fee applies to include a medical device, including IVD device, in the ARTG that is for export only.

Table 33: Export only devices
Export only applications Fee Schedule 5 Part 1
Application for inclusion into the ARTG of export only devices $90 Item 1.5(f)
Application for inclusion into the ARTG of export only IVD devices $90 Item 1.5(i)

This fee is in the Therapeutic Goods (Medical Devices) Regulations 2002

Biologicals

Version 1.3, November 2020

Below are the fees and annual charges for manufacturing and sponsoring biologicals.

The Australian Regulatory Guidelines for Biologicals (ARGB) provide information on the legal arrangements in Australia for the supply and use of human cell and tissue-based therapeutic goods (collectively defined as 'biologicals').

For clinical trials supplying unapproved biologicals, go to Clinical trials.

Annual charges for manufacturing biologicals

There is no annual charge for a manufacturer who only manufactures biologicals [regulation 7(5)(j) Therapeutic Goods (Charges) Regulations 2018].

Manufacturing biologicals fees

There is an application fee and various inspection fees for manufacturing biologicals.

Table 34: Manufacturing biologicals fees
Manufacturing biologicals Fee Schedule 9A Part 2
Australian manufacturing sites - application fee for a manufacturing licence $1,130 Item 3
Initial manufacturing audit - inspection fee for Australian and overseas manufacturing sites $22,300 Item 12
Subsequent manufacturing audit - inspection fee for Australian and overseas manufacturing sites $16,900 Item 13
Inspection fee for each hour of preparation by each inspector for an inspection conducted outside Australia $690 /hour/inspector Item 14
Inspection fees to cover costs and reasonable expenses by each inspector, including costs for accommodation and allowance outside Australia Costs and reasonable expenses Item 15

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

Annual charges for sponsoring biologicals

There are annual charges for including a biological in the ARTG.

Table 35: Annual charges for sponsoring biological
ARTG inclusion of biologicals Amount Regulation
Class 1 biological annual charge for ARTG inclusion $690 Item 7(3)(a)
Class 2, 3, 4 biological annual charge for ARTG inclusion $6,890 Item 7(3)(b)

These charges are in the Therapeutic Goods (Charges) Regulations 2018

Fees for sponsoring biologicals

Table 36: Fees for sponsoring biologicals
Sponsoring biologicals Fee Schedule 9A Part 2
Ingredient or component of a biological to be evaluated under regulation 16GF - evaluation fee $24,400 Item 7
Class 1 biological - application fee for inclusion in ARTG $1,130 Item 1
Class 2, 3, 4 biological - application fee for inclusion in ARTG $1,130 Item 2
Variation application fee - all classes $1,130 Item 8
Class 2 biological - evaluation fee for inclusion in ARTG $75,100 Item 4
Class 2 biological - evaluation fee for variation to ARTG entry $6,890 Item 9
Class 3 biological - evaluation fee for inclusion in ARTG $150,300 Item 5
Class 4 biological - evaluation fee for inclusion in ARTG $244,200 Item 6
Class 3 or 4 biological - evaluation fee for major variation to ARTG entry $35,600 Item 11
Class 3 or 4 biological - evaluation fee for minor variation to ARTG entry $18,100 Item 10
Safety related variations - evaluation of application under section 9D(3AA) $6,890 Item 8A

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

Blood, blood components and HPCs

Version 1.3, November 2020

Below are the fees and annual charges for human blood, blood components, haematopoietic progenitor cells (HPC) and human tissues not regulated as biologicals.

Manufacturing annual charges

Table 37: Manufacturing annual charges
Therapeutic good being manufactured Charge Regulation
Blood and blood components (not HPCs) - primary manufacturing site $166,800 Item 7(5)(f)(i)
Blood and blood components (not HPCs) - a fixed (non-mobile) manufacturing site $8,210 Item 7(5)(f)(ii)
HPCs manufacturing site $7,180 Item 7(5)(g)

These charges are in the Therapeutic Goods (Charges) Regulations 2018

Only highest applicable charge is payable

Manufacturing fees

Table 38: Manufacturing fees
Manufacturing fees Fee Schedule 9 Part 2
Australian manufacturing sites - application fee for a manufacturing licence $1,060 Item 8(b)
Blood and blood components (not HPCs) - Australian primary manufacturing site - inspection fee $940/inspector/hour Item 9AB
Blood and blood components (not HPCs) - Australian manufacturing site other than the primary site - inspection fee $690/inspector/hour Item 9AC
HPCs - Australian manufacturing site inspection fee $690/inspector/hour Item 9AA
Human tissues that are not biologicals - Australian manufacturing site - inspection fee $690/inspector/hour Item 9ACA

These fees are in Schedule 9, Therapeutic Goods Regulations 1990

Blood plasma and technical master files

The evaluation fee for blood plasma master files and blood technical master fees depends on the number of pages.

Table 39: Blood plasma and technical master files
Pages Fee Schedule 9 Part 2
1-10 $1,370 Item 9AD(a)
11-50 $11,600 Item 9AD(b)
51-100 $26,100 Item 9AD(c)
101-1000 $35,100 Item 9AD(d)
1001-3000 $54,700 Item 9AD(e)
3001-4000 $72,900 Item 9AD(f)
>4000 $89,000 Item 9AD(g)

These fees are in Schedule 9, Therapeutic Goods Regulations 1990

Miscellaneous fees

This fee applies to human blood, blood components and HPCs and human tissues not regulated as biologicals.

Table 40: Miscellaneous fees
Application type Fee Schedule 9 Part 2
Application for consent by the Secretary under sections 14 and 14A of the Act to the import, export or supply of therapeutic goods that do not comply with an applicable standard where the application relates to a single entry in the register. $490 Item 1A(a)
Application for consent by the Secretary under sections 14 and 14A of the Act to the import, export or supply of therapeutic goods that do not comply with an applicable standard where the application relates to two or more entries in the register.

$490 for the first entry

plus $100 for each additional entry

Item 1A(b)

This fee in Schedule 9, Therapeutic Goods Regulations 1990

Medical devices

Version 1.3, November 2020

Medical devices are included (not listed or registered) in the ARTG.

Sponsoring medical devices

Annual charges

These charges are for inclusion of the following kinds of medical devices (other than medical devices produced for export) in the ARTG, except for medical devices mentioned in Table 42.

Table 41: Annual charges
Class of medical device Charge Regulation
AIMD $1,200 Item 7(4)(d)
Class III $1,200 Item 7(4)(d)
Class IIb $940 Item 7(4)(c)
Class IIa $940 Item 7(4)(c)
Class I - sterile $640 Item 7(4)(b)
Class I - measuring function $640 Item 7(4)(b)
Class I - other $90 Item 7(4)(a)

These charges are in the Therapeutic Goods (Charges) Regulations 2018

Annual charges for medical devices listed on the Prostheses List

These charges are for inclusion of the following kinds of medical devices listed prostheses in the ARTG under Chapter 4 of the Therapeutic Goods Act 1989. A medical device is a listed prosthesis within the meaning of the Private Health Insurance (Prostheses) Rules (No 1) 2020, effective 7 April 2020.

These charges are only in effect for the financial year 1 July 2020 to 30 June 2021.

Table 42: Annual charges for medical devices listed on Prostheses List
Class of medical device Charge Regulation
AIMD $600 Item 7(4A)(b)
Class III $600 Item 7(4A)(b)
Class IIa $470 Item 7(4A)(a)
Class IIb $470 Item 7(4A)(a)

These charges are in the Therapeutic Goods (Charges) Regulations 2018

Application fees

These fees are to apply to include a medical device in the ARTG. Application audit assessment fees are often payable as well. Application fees for export only devices are not included in this section.

Table 43: Application fees
Class of medical device Application fee Schedule 5 Part 1
AIMD $1,370 Item 1.5(a)
Class III $1,370 Item 1.5(b)
Class IIb $1,060 Item 1.5(c)
Class IIa $1,060 Item 1.5(d)
Class I - sterile $1,060 Item 1.5(e)
Class I - measuring function $1,060 Item 1.5(e)
Class I - other (excluding export only devices) $550 Item 1.5(g)

These fees are in the Therapeutic Goods (Medical Devices) Regulations 2002
Note: Refer to export only device application fees

Application for medical devices (priority applicant) determination

This fee is for applicants seeking priority review designation for an application to include a medical device in the ARTG.

For guidance on how to seek priority review, go to Priority review designations medical devices (including IVDs).

Table 44: Application for medical devices (priority applicant) determination
Application type Application fee Schedule 5 Part 1
Medical devices (priority applicant) determination in relation to a medical device $10,200 Item 1.5A

This fee is in the Therapeutic Goods (Medical Devices) Regulations 2002

Application audit assessment fees

An application audit assessment fee is payable in addition to the application fee for the inclusion of some medical devices in the ARTG.

Table 45: Application audit assessment fees
Type of application audit Assessment fee Schedule 5 Part 1
Level 1 - verification of sponsor's application and evidence of conformity $3,990 Item 1.13
Level 2 - Level 1 activities plus review of evidence of conformity $7,310 Item 1.14

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

Variation fees

For guidance on variations go to Varying entries in the ARTG - medical devices and IVDs.

Table 46: Variation fees
Application type Application fee Schedule 9 Part 2
Variation to an ARTG inclusion entry $470 Item 2A(g)

These fees are in Schedule 9, Therapeutic Goods Regulations 1990

Miscellaneous

Table 47: Miscellaneous
Type of application Fee Schedule 5 Part 1
Considering submissions to the Secretary in relation to a proposed suspension of a kind of medical device from the ARTG (as described in item 1.6) $7,310 Item 1.14
Application for consent of Secretary to importation into Australia, supply for use in Australia, or exportation from Australia of a medical device, including an IVD medical device, for a single entry in the register $490 (for all the devices to which the application relates) Item 1.15(a)
Application for consent of Secretary to importation into Australia, supply for use in Australia, or exportation from Australia of a medical device, including an IVD medical device, for a two or more entries in the register

$490 for the first entry plus

$100 for each additional entry

Item 1.15(b)

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

Conformity assessment bodies designation determination

These applications have both an application fee and an assessment fee.

Table 48: Conformity assessment bodies designation determination
Application type Application fee Assessment fee Regulation
Full designation conformity assessment body determination $4,660 $76,100 Item 1.4A and Item 1.4D
Partial designation conformity assessment body determination (full QMS) $2,560 $54,600 Item 1.4B and Item 1.4E
Partial designation conformity assessment body determination (partial QMS or partial devices) $2,560 $54,600 Item 1.4C and Item 1.4F

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

Manufacturing medical devices

Information about conformity assessment is in Part 1, Australian regulatory guidelines for medical devices. Fees are in Therapeutic Goods (Medical Devices) Regulations 2002.

Application for conformity assessment

Table 49: Application for conformity assessment
All conformity assessment procedures Fee Schedule 5 Part 1
Application fee $1,040 Item 1.1

This fee is in the Therapeutic Goods (Medical Devices) Regulations 2002

Application for conformity assessment (priority applicant) determination

This fee is for applicants seeking priority review designation for an application for TGA conformity assessment of a medical device.

Table 50: Application for conformity assessment (priority applicant) determination
Application type Application fee Schedule 5 Part 1
Conformity assessment (priority applicant) determination in relation to a medical device $10,200 Item 1.1A

This fee is in the Therapeutic Goods (Medical Devices) Regulations 2002

Initial assessment of conformity assessment

In addition to the application fee, one or more of the following fees will apply to your kind of medical device. Conformity assessment procedures are legislated in Schedule 3, Therapeutic Goods (Medical Devices) Regulations 2002.

Table 51: Initial assessment of conformity assessment
Type of conformity Fee for initial assessment Schedule 5 Part 1
Full quality management system inspection (described in Schedule 3, Part 1) $30,900 Item 1.9(a)
Design examination (described in Schedule 3, Clause 1.6) $60,700 Item 1.9(b)
Type examination (including management of testing, analysis, and reporting on examination of the type) (described in Schedule 3, Part 2) $42,300 Item 1.9(c)
Verification (including management of testing, analysis, and reporting on verification tests) (described in Schedule 3, Part 3) $29,600 Item 1.9(d)
Production quality management system inspection (described in Schedule 3, Part 4) $27,000 Item 1.9(e)
Product quality management system inspection (described in Schedule 3, Part 5) $23,100 Item 1.9(f)

These fees are in Schedule 5 Therapeutic Goods (Medical Devices) Regulations 2002

Changes to conformity assessment

Conformity assessment procedures are legislated in Schedule 3, Therapeutic Goods (Medical Devices) Regulations 2002.

Type of conformity Fee for change Schedule 5 Part 1
Full quality management system inspection (described in Schedule 3, Part 1) $18,600 Item 1.10(a)
Design examination (described in Schedule 3, Clause 1.6) $36,600 Item 1.10(b)
Type examination (including management of testing, analysis, and reporting on examination of the type) (described in Schedule 3, Part 2) $25,500 Item 1.10(c)
Production quality management system inspection (described in Schedule 3, Part 4) $16,000 Item 1.10(d)
Product quality management system inspection (described in Schedule 3, Part 5) $14,100 Item 1.10(e)

These fees are in Schedule 5 Therapeutic Goods (Medical Devices) Regulations 2002

Surveillance inspections - conformity assessment

Conformity assessment procedures are legislated in Schedule 3, Therapeutic Goods (Medical Devices) Regulations 2002.

Table 53: Surveillance inspections - conformity assessment
Type of surveillance inspection Fee Schedule 5 Part 1
Full quality management system surveillance inspection (described in Schedule 3, Part 1) $8,970 Item 1.2(a)
Production quality management system surveillance inspection (described in Schedule 3, Part 4) $8,970 Item 1.2(a)
Product quality management system surveillance inspection (described in Schedule 3, Part 5) $8,970 Item 1.2(a)

These fees are in Schedule 5 Therapeutic Goods (Medical Devices) Regulations 2002

Review of certificate of conformity assessment

Conformity assessment procedures are legislated in Schedule 3, Therapeutic Goods (Medical Devices) Regulations 2002.

Table 54: Review of certificate of conformity assessment
Type of certificate being reviewed Fee Schedule 5 Part 1
Design examination re-assessment (described in Schedule 3, Clause 1.6) $54,800 Item 1.3(a)
Type examination re-assessment (including management of testing, analysis, and reporting on examination of the type) (described in Schedule 3, Part 2) $42,300 Item 1.3(b)

These fees are in Schedule 5 Therapeutic Goods (Medical Devices) Regulations 2002

Additional inspection fees

For medical devices that incorporate a medicine, application and evaluation fees apply for the medicine component as well as fees related to assessing the device.

Table 55: Additional inspection fees
Inspection costs Fee Schedule 5 Part 2
Supplementary additional assessment conducted outside Australia in addition to assessment mentioned in item 1.2, 1.3, 1.9 or 1.10, Schedule 5 $440/hour/assessor Item 2.1(b)
Costs and reasonable expenses of travel by each assessor involved, including travel both in and outside Australia Costs and reasonable expenses Item 2.1(a)
Cost of testing incurred in purchasing, establishing and setting up the equipment to be used to conduct the tests and the direct costs of conducting the tests (including the cost of any consumables used to conduct the tests) At cost Item 2.2

Conformity assessment fees are in Schedule 5, Therapeutic Goods (Medical Devices) Regulations 2002

Issuing quality systems certificates

Table 56: Issuing quality systems certificates
Certificate Fee
Quality systems certificate $180
Certified copy of quality systems certificate $70

IVD medical devices

Version 1.3, November 2020

The TGA website has information about IVD regulation basics.

Sponsoring IVDs

Annual charges

Table 57: Annual charges
Class of IVD Charge Regulation
All classes of IVD (excluding Class 4 in-house IVDs) $690 Item 7(4)(e)
Class 4 in-house IVDs n/a Item 7(4)(f)

These charges are in the Therapeutic Goods (Charges) Regulations 2018
n/a: not applicable

Notification fee

Laboratories that manufacture Class 1, Class 2 or Class 3 in-house IVDs are required to provide a notification to the TGA. These in-house IVDs are not required to be included in the ARTG.

Table 58: Notification fee
Class of IVD Notification fee Schedule 5 Part 1
Notification by a laboratory of its Class 1, Class 2 or Class 3 in-house IVDs $1,060 Item 1.17

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

Application fees

These fees are to apply to include an IVD in the ARTG. Application audit assessment fees are also often payable.

For guidance on variations go to Varying entries in the ARTG - medical devices and IVDs.

Table 59: Application fees
Application Application fee Regulation
Application for inclusion into the ARTG of all classes of IVD, including Class 4 in-house IVDs (excluding export only IVD devices) $1,060

Therapeutic Goods (Medical Devices) Regulations 2002,
Schedule 5 Part 1,

Item 1.5(h)

These fees are in the Therapeutic Goods (Medical Devices) Regulations 2002 and Therapeutic Goods Regulations 1990

Application for medical devices (priority applicant) determination

This fee is for applicants seeking Priority Review designation for an application to include an IVD in the ARTG.

Table 60: Application for medical devices (priority applicant) determination
Application type Application fee Schedule 5 Part 1
Medical devices (priority applicant) determination in relation to a medical device (including an IVD) $10,200 Item 1.5A

This fee is in the Therapeutic Goods (Medical Devices) Regulations 2002

Application audit assessment fees

An application audit assessment fee is payable in addition to the application fee for the inclusion of some medical devices in the ARTG.

Go to IVD guidance documents: Application audit (technical file review) and Regulatory requirements for in-house IVDs for more details.

Table 61: Application audit assessment fees
Type of IVD Assessment fee Schedule 5 Part 1
Class 1, Class 2 and Class 3 IVDs $7,130 Item 1.14A
Class 4 in-house IVDs $66,000 Item 1.14B
Class 4 in-house immunohaematology reagent IVD $16,000 Item 1.14C

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

Manufacturing IVDs

Application for conformity assessment

Table 62: Application for conformity assessment
All conformity assessment procedures Fee Schedule 5 Part 1
Application fee $1,040 Item 1.1

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

Application for conformity assessment (priority applicant) determination

This fee is for applicants seeking Priority Review designation for an application for TGA conformity assessment of an IVD.

Table 63: Application for conformity assessment (priority applicant) determination
Application type Application fee Schedule 5 Part 1
Conformity assessment (priority applicant) determination in relation to a medical device (including an IVD) $10,200 Item 1.1A

This fee is in the Therapeutic Goods (Medical Devices) Regulations 2002

Initial assessment of conformity assessment

In addition to the application fee, one or more of the following fees will apply to your kind of medical device.

Conformity assessment procedures are legislated in Schedule 3, Therapeutic Goods (Medical Devices) Regulations 2002.

Table 64: Initial assessment of conformity assessment
Type of conformity Fee Schedule 5 Part 1
Full quality management system inspection: described in Schedule 3, Part 1 $31,000 Item 1.9A(a)
Design examination: described in Schedule 3, Clause 1.6 $66,000 Item 1.9A(b)
Design examination - immunohaematology reagent: described in Schedule 3, Clause 1.6 $16,000 Item 1.9A(c)
Type examination: described in Schedule 3, Part 2 $42,700 Item 1.9A(e)
Production quality management system inspection: described in Schedule 3, Part 4 $27,200 Item 1.9A(f)

These fees are in Schedule 5 Therapeutic Goods (Medical Devices) Regulations 2002

Review of certificate of conformity assessment

Conformity assessment procedures are legislated in Schedule 3, Therapeutic Goods (Medical Devices) Regulations 2002.

Table 65: Review of certificate of conformity assessment
Type of certificate being reviewed Fee Schedule 5 Part 1
Full quality management system inspection: described in Schedule 3, Part 1 $31,000 Item 1.3A(a)
Design examination: described in Schedule 3, Clause 1.6 $66,000 Item 1.3A(b)
Design examination - immunohaematology reagent: described in Schedule 3, Clause 1.6 $16,000 Item 1.3A(c)
Type examination: described in Schedule 3, Part 2 $42,700 Item 1.3A(e)
Production quality management system inspection: described in Schedule 3, Part 4 $27,200 Item 1.3A(f)

These fees are in Schedule 5 Therapeutic Goods (Medical Devices) Regulations 2002

Other IVD conformity assessment fees

Table 66: Other IVD conformity assessment fees
Other assessment for IVD conformity assessment Fee Schedule 5
Supplementary additional assessment in addition to assessment mentioned in item 1.2, 1.3A, 1.9A or 1.10A [item 2.1(b), Schedule 5] $440/assessor hour Item 1.12
Costs and reasonable expenses of travel by each assessor involved, including travel both in and outside Australia Costs and reasonable expenses Item 2.1(a)
Surveillance assessment for conformity assessment certificate under Schedule 3, Part 1 or 4 $9,020 Item 1.2(b)
Assessment of changes to IVD or QMS for applicable IVD 60% of the relevant 'initial assessment' fee* under item 1.9A Item 1.10A
Considering a submission to the Secretary in relation to a proposed suspension of a conformity assessment certificate $7,130 Item 1.14A

Conformity assessment fees are in Schedule 5, Therapeutic Goods (Medical Devices) Regulations 2002
* for relevant 'initial assessment' fees

Other listed and registered therapeutic goods (OTGs)

Version 1.3, November 2020

Other listed and registered therapeutic goods (OTGs) include:

OTGs are the goods that meet the definition of a therapeutic good, but do not meet the definition of a medical device, a medicine or a biological.

In this section, we have only included fees and charges that directly apply to these goods.

For a complete list, go to the relevant legislation.

Annual charges

Table 67: Annual charges
Type of OTG Charge Regulation
Listed OTG: disinfectants $880 Item 7(1)(c)(iii) and Item 7(2)(c)(iii)
Registered OTG: disinfectants $1,700 Item 7(1)(a)(iii) and Item 7(2)(a)(iii)

These charges are in the Therapeutic Goods (Charges) Regulations 2018

Listed OTG fees

Table 68: Listed OTG fees
Listed OTG fee type Fee Schedule 9 Part 2
Application fee $470 Item 3(a)
Variation fee $470 Item 2A(ba)

These fees are in Schedule 9, Therapeutic Goods Regulations 1990
* Fee for evaluating documents and information relating to the safety of a listed OTG will be in Schedule 9, Therapeutic Goods Regulations 1990 - regulatory changes pending

Miscellaneous fees

Application for consent by the Secretary under sections 14 and 14A of the Act to the import, export or supply of therapeutic goods that do not comply with an applicable standard

Table 69: Miscellaneous fees
Application type Fee Schedule 9 Part 2
Where the application relates to a single entry in the register. $490 Item 1A(a)
Where the application relates to two or more entries in the register.

$490 for the first entry

plus $100 for each additional entry

Item 1A(b)

This fee is in Schedule 9, Therapeutic Goods Regulations 1990

Clinical trials

Version 1.3, November 2020

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

Unapproved medicines

These fees are for clinical trials of unapproved medicines.

Table 70: Unapproved medicines
Unapproved medicines Fee Schedule 9 Part 2
Clinical trial notification (CTN) $380 Item 14(a)
Clinical trial notification (CTN) - for each notification of one or more additional trial sites $380 Item 14(b)
Clinical trial approval (CTA) - 30 day evaluation $1,790 Item 1(a)
Clinical trial approval (CTA) - 50 day evaluation $22,300 Item 1(b)

These fees are in Schedule 9, Therapeutic Goods Regulations 1990

Unapproved biologicals

These fees are for clinical trials of unapproved biologicals.

Table 71: Unapproved biologicals
Biologicals Fee Schedule 9A Part 2
Clinical trial notification (CTN) $380 Item 17(a)
Clinical trial notification (CTN) - for each notification of one or more additional trial sites $380 Item 17(b)
Clinical trial approval (CTA) $27,100 Item 16

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

Unapproved medical devices (including IVDs)

These fees are 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) $380 Item 1.8
Clinical trial approval (CTA) $19,000 Item 1.7

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

Unapproved other therapeutic goods

These fees are 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) $380 Item 14A(a)
Clinical trial notification (CTN) - for each notification of one or more additional trial sites $380 Item 14A(b)
Clinical trial approval (CTA) - with no clinical studies to demonstrate safety and effectiveness $2,850 Item 1(d)
Clinical trial approval (CTA) - with clinical studies to demonstrate safety and effectiveness $19,000 Item 1(c)

These fees are in Schedule 9, Therapeutic Goods Regulations 1990

General fees

Version 1.3, November 2020

Transfer of sponsorship

There are no fees for the transfer of sponsorship. However, there are fees associated with some changes to therapeutic goods that occur because of sponsor transfer, such as changes to registered medicine labels or variation of ARTG entry following acceptance of a new Manufacturer Evidence.

Fees related to annual charge exemption (ACE) scheme

To maintain an annual charge exemption, sponsors are able to self-declare that their product had no turnover. Self-declarations must be submitted to the TGA between 1 July and 22 July each year or it will be assumed that the product generated greater than $0 turnover.

Late notice declarations made before 15 September under regulation 43AAE(2) of the Therapeutic Goods Regulations 1990 attract a late notice declaration fee.

Table 74: Fees related to annual charge exemption (ACE) scheme
Number of ARTG entries Late notice declaration fee Schedule 9 Part 2
If the declaration relates to not more than 5 entries in the ARTG $440 Item 3AB(a)
If the declaration relates to 6 or more entries in the ARTG $440 for first 5 entries + $50 for each additional entry Item 3AB(b)

Fees are in the Therapeutic Goods Regulations 1990

Fees related to a request to revoke an ARTG entry cancellation

There are fees for the requests for revocation of:

  • the voluntary cancellation of an ARTG entry by the sponsor
  • the cancellation of an ARTG entry that was cancelled due to non-payment of the annual charge
Table 75: Fees related to a request to revoke an ARTG entry cancellation
Number of ARTG entries Fee for revocation of cancellation Regulation
If the request relates to one entry in the ARTG $160

Therapeutic Goods (Medical Devices) Regulations 2002:

Schedule 5, Part 1 Item 1.6A(a) and Item 1.6B(a)

Therapeutic Goods Regulations 1990:

Schedule 9, Part 2 Item 6BA(a) and Item 6BB(a)

Therapeutic Goods Regulations 1990:

Schedule 9A, Part 2 Item 16A(a) and Item 16B(a)

If the request relates to more than one entry in the ARTG

$160 for first entry and

$50 for each additional entry

Therapeutic Goods (Medical Devices) Regulations 2002:

Schedule 5, Part 1 Item 1.6A(b) and Item 1.6B(b)

Therapeutic Goods Regulations 1990:

Schedule 9, Part 2 Item 6BA(b) and Item 6BB(b)

Therapeutic Goods Regulations 1990:

Schedule 9A, Part 2 Item 16A(b) and Item 16B(b)

Fees are in the Therapeutic Goods (Medical Devices) Regulations 2002 and Therapeutic Goods Regulations 1990

Version history

Version 1.3, November 2020

Version Description of change Author Effective date
V1.0 Original publication for the financial year July 2020 to June 2021 Regulatory Services and Drug Control Branch 01/07/2020
V1.1 Update to Table 68 Regulatory Services and Drug Control Branch July 2020
V1.2 Update to Table 5 Regulatory Services and Drug Control Branch September 2020
V1.3 Minor updates to reflect CTA name change Biological Science Section November 2020