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.
| 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 1 6 $4 740 Efficacy and Safety 1 6 $4 740 Efficacy and Safety 2 4 $1 950 Finalisation 2 2 $3 090 Finalisation 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.
The APVMA will peer review international assessment reports, re-evaluate individual studies, and re-write individual assessments where we arrive at a different scientific interpretation, or if the international assessment contains inadequate detail.
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.
If you have data to support an application in a language other than English, this should be brought to the APVMA’s attention during Pre Application Assistance.
Data items or packages translated from languages other than English may be used in support of an application. The untranslated data package or item, and a certified copy of the translated data package should be submitted with the application. Alternatively, argument may be submitted as to why data has not been translated.