International and other national assessments

The Australian Pesticides and Veterinary Medicines Authority (APVMA) will accept assessments from trusted overseas regulators. This may lead to reduced timeframes and fees for the applicants. The assessments can be from international organisations or other national regulators provided accepted guidelines and standards have been followed.

The active constituent or product intended for approval or registration in Australia must be the same as that assessed by the overseas regulator. Further information on the criteria for APVMA accepting an overseas assessment is below.

A pre-application assistance (PAA) project plan will need to be created to utilise this pathway.

Fee and timeframe savings

Module level reductions shown in Table 1 should be discussed and confirmed through PAA. The module descriptors explain which module levels apply for different situations.

Table 1: International assessment – lower module levels

Area

Module without overseas assessment

Module with relevant overseas assessment

Chemistry

Chemistry 1

Chemistry 3

Chemistry 2

Chemistry 3

Efficacy and Safety

Case-by-case for discussion at pre-application assistance. APVMA aims to use elements of overseas assessment to the fullest extent possible and apply cost/time savings as appropriate.

Environment

Environment 1

Environment 2

Environment 2

Environment 3

Health

Health 1

Health 3

Residues

Residues 1

Residues 2

Residues 2

Residues 4

Overseas assessment module examples

  • Click to view pesticide example 1

    Pesticide example 1

    Item 2 application – Approval of a new active constituent and registration of the product – fruit thinning product for use in pome fruit. Some local (Australian) efficacy and residues studies were submitted, supported by international data and assessments (chemistry, health, residues and environment) from a trusted overseas regulator where the product is already approved for this use.   

    In this case, a cost saving is achieved, but not a time saving because the longest assessment module (poisons scheduling at 13 months) does not change.

    Note: A PAA would be required to provide advice on whether overseas assessments will be acceptable. This would generally involve a tier 2 PAA at a cost of $962.50 (written advice only) or $1,375 (if meeting requested) and timeframe of 2 months. A portion of the PAA fee is redeemable when the registration application is submitted.

    New modules (1 February 2023)

    Modules applied when overseas assessments are provided

    Module

    Timeframe

    (months)

    Fee

    Module

    Timeframe
    (months)

    Fee

    Preliminary assessment

    N/A

    $902

    Preliminary assessment

    N/A

    $902

    Chemistry 1

    13

    $11 074

    Chemistry 3

    6

    $1 954

    Health 1

    13

    $36 740

    Health 3

    9

    $18 980

    Poison Scheduling

    13

    $2 435

    Poison Scheduling

    13

    $2 435

    Residues 1

    13

    $25 650

    Residues 2

    8

    $11 149

    Environment 1

    13

    $26 390

    Environment 2

    7

    $7 659

    Efficacy and safety 1

    6

    $4 740

    Efficacy and safety 1

    6

    $4 740

    Finalisation 1

    3

    $8 110

    Finalisation 1

    3

    $8 110

    Limits on use of information

    $460 

    Limits on use of information

    $460

    Total

    16

    $116 501

    Total

    16
    (plus PAA)

    $56 389
    (plus PAA)

  • Click to view pesticide example 2

    Pesticide example 2

    Item 10 application – Registration of a new fungicide which is a new combination of existing actives for use on a major crop group. It is the first use of one of the actives in a food crop. The application method has been established for both actives separately.

    The applicant has provided a full overseas dossier with assessment reports for all risk areas from a trusted regulator where the product is already approved, supported by Australian efficacy and residues trials.

    In this case a 4 month time saving and a cost saving of $19,181 (not including PAA) is achieved.

    New modules (1 February 2023)

    Modules applied when overseas assessments are provided

    Module

    Timeframe

    (months)

    Fee

    Module

    Timeframe

    (months)

    Fee

    Preliminary assessment

    N/A

    $902

    Preliminary assessment

    N/A

    $902

    Chemistry 3

    6

    $1 954

    Chemistry 3

    6

    $1 954

    Health 3

    9

    $18 980

    Health 3

    9

    $18 980

    Residues 1

    13

    $25 650

    Residues 2

    8

    $11 149

    Environment 2

    7

    $7 659

    Environment 3

    4

    $2 979

    Efficacy and Safety 1

    6

    $4 740

    Efficacy and Safety 1

    6

    $4 740

    Finalisation 1

    3

    $8 110

    Finalisation 1

    3

    $8 110

    Limits on use of information

    $460

    Limits on use of information

    $460

    Total

    16

    $68 455

    Total

    12
    (plus PAA)

    $49 274
    (plus PAA)

  • Click to view veterinary example

    Veterinary example 

    Item 2 application – Registration of a new injectable vaccine (containing a new immunobiological) for use in companion animals (dogs and cats). The applicant has provided overseas chemistry and efficacy data from a trusted regulator.

    The guidance in the new module descriptors suggests that the efficacy modules may be reduced if overseas efficacy is considered suitable for the Australian context.

    In this case, we have shown two options: with an Efficacy and Safety 1 module and with an Efficacy and Safety 2 module when the overseas assessment is suitable.

    A PAA would be required to provide advice on whether overseas assessments will be acceptable. This would generally involve a tier 2 PAA at a cost of $962.50 (written advice only) or $1,347.50 (if meeting requested) and timeframe of 2 months. A portion of the fee is redeemable when the registration application is submitted.

    New modules (1 February 2023)

    Modules applied when overseas assessments are provided

    Module

    Timeframe

    (months)

    Fee

    Module

    Timeframe

    (months)

    Fee

    Preliminary assessment

    –1

    $902

    Preliminary assessment

    –1

    $902

    Chemistry 2

    9

    $3 075

    Chemistry 3

    6

    $1 954

    Efficacy and Safety 8.1

    6

    $4 740

    Efficacy and Safety 8.1

    6

    $4 740

    Efficacy and Safety 8.2

    4

    $1 950

    Finalisation 11.2

    2

    $3 090

    Finalisation 11.2

    2

    $3 090

    Limits on use of information

     

    $460

    Limits on use of information

     

    $460

    Total

    11

    $12 267

    Total

    8

    $11 146

    OR

    $8 356

Countries and official bodies we accept assessments from

We accept relevant scientific assessments from the following countries and scientific bodies:

  • WHO and FAO – including the Joint FAO/WHO Meeting on Pesticide Residues (JMPR) and Joint FAO/WHO Expert Committee on Food Additives (JECFA)
  • USA, Canada, European Union, New Zealand
  • Australian regulatory counterparts, including the Therapeutic Goods Administration (TGA), Food Standards Australia New Zealand (FSANZ), the Australian Industrial Chemicals Induction Scheme (AICIS) and the Office of the Gene Technology Regulator (OGTR)

We accept a range of scientific reports including regulatory advice reports and reports supporting the establishment of international standards, such as MRLs. The types of reports we accept include:

  • hazard assessments – mammalian toxicology, environmental toxicology
  • component assessment reports – chemistry, environmental fate, residues, efficacy or target animal/crop safety
  • exposure assessments – human (dietary, bystander, worker) or environmental where the use pattern and environmental conditions are consistent with Australia
  • human health or environmental risk assessments (comprising both hazard and exposure assessments, and risk characterisation) where the use pattern and environmental conditions are consistent with Australia
  • regulatory submission dossiers made to a regulatory authority in another country comprising risk assessment and risk management components.

Our criteria for accepting an international or other national assessment

For us to accept an international or other national assessment, the active constituent or product that was the basis of the overseas assessment must be the same as the active constituent or product intended for approval or registration in Australia. The international assessment must also:

  • be written in English
  • contain a full reference list of all the studies cited in the report
  • be an unredacted report with an adequate level of reporting detail so that a regulatory scientist can peer review the assessment and fully understand the basis for any interpretations, conclusions, recommendations or decisions
  • be submitted in an electronic format that is searchable, and ideally, editable. It does not need to be specifically formatted for the APVMA
  • be the most recent comprehensive assessment where there are multiple assessments arriving at similar conclusions. If the reports have differing conclusions then all must be submitted to the APVMA
  • include all underlying data and studies relevant to the application, including published and unpublished studies
  • be accompanied by all original studies cited or evaluated in the international assessment including those not owned by the applicant.

Additional data may also be required when component assessments influenced by use patterns such as residues and exposure assessments (e.g. dietary, occupational, environment) cannot be extrapolated to Australian use. For example, we may require additional data on acute toxicity for a JMPR or JECFA evaluation to enable appropriate safety directions to be established.

The APVMA will peer review the assessment report and will only re-evaluate individual studies and re-write individual assessments where we arrive at a different scientific interpretation, or there is inadequate detail in the international assessment. 

Your feedback will be submitted to the APVMA anonymously. If you require a response, please contact us.