This content is current only at the time of printing. This document was printed on 20 April 2018. A current copy is located at https://apvma.gov.au/node/14186
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Guidance for applicants – submission of international data, standards and assessments
The Australian Government has set the guiding principle that, if a system, service or product is approved under a trusted international standard or risk assessment, Australian regulators should not impose any additional requirements—unless it can be demonstrated that there is a good reason to do so. To support this principle, the APVMA has developed this guidance for applicants on the acceptance of international data, standards and assessments as part of the approval, registration and chemical review (reconsideration) processes.
The use of international assessments reduces the amount of time applicants spend reformatting a regulatory dossier specifically for Australia and the amount of technical report writing by the APVMA.
The use of international assessments does not remove the APVMA’s need to undertake a scientific evaluation of the proposed product and its uses in order to determine if current statutory criteria are met, specifically the safety, efficacy and trade criteria.
The APVMA will continue to accept data and studies generated overseas and only seek to supplement this data where necessary for local use patterns and environmental conditions.
Data generated according to the following international guidelines will be accepted by the APVMA if relevant to a specific product and application for registration:
- Organisation for Economic Co-operation and Development (OECD) test guidelines
- Veterinary International Conference on Harmonization (VICH) guidelines
- Food and Agricultural Organization of the United Nations (FAO) and World Health Organization (WHO) guidelines for data generation
- test guidelines published by the United States Environmental Protection Agency (US EPA), Canadian Pest Management Regulatory Agency (PMRA), European Food Safety Authority (EFSA) for plant protection (pesticide) products, the EU Biocidal Products Regulations, the European Medicines Agency (EMA) for veterinary medicine products and the US Food and Drug Administration (US FDA).
- European and Mediterranean Plant Protection Organisation (EPPO) standards for the efficacy evaluation of plant protection products.
Applicants must continue to provide data consistent with the APVMA’s data guidelines.
The APVMA will continue to use international standards, such as chemistry specifications, as part of its regulatory assessments. This includes the following:
- FAO standards and specifications for pesticide active constituents and associated products
- European, British and US pharmacopeial standards for veterinary active and non-active constituents.
The APVMA will look for opportunities to use other international standards on a case-by-case basis but will continue to establish Australian-specific maximum residue limits (MRLs) and health-based guidance values including acceptable daily intakes (ADIs) and acute reference doses (ARfD).
The APVMA has developed the following guidance to assist applicants with their decision to submit an international assessment and to outline the process the APVMA will follow when using an international assessment to make a regulatory decision. Unless specified, all current legislative, administrative and scientific processes followed by the APVMA in the evaluation of an application incorporating an international assessment will continue.
The APVMA encourages the submission of international assessments to support applications for the approval of new active constituents, registration of new products, variations/extensions to currently registered products, permits or as part of a chemical reconsideration (review).
- An international assessment is a scientific report prepared by:
- a regulatory agency in another country as part of the approval process for an agricultural chemical or veterinary medicine
- an independent international scientific body such as the WHO or FAO for the purpose of providing advice to regulatory authorities or as part of the process for establishing international standards, such as MRLs
- An international assessment can be:
- hazard assessment – mammalian toxicology, environmental toxicology
- component assessment reports – chemistry, environmental fate, residues, efficacy or target animal/crop safety
- exposure assessment – human (dietary, bystander, worker) or environmental where the use pattern and environmental conditions are consistent with Australia
- human health or environmental risk assessment (comprising both hazard and exposure assessments, and risk characterisation) where the use pattern and environmental conditions are consistent with Australia
- regulatory submission dossier made to a regulatory authority in another country comprising risk assessment and risk management components.
The APVMA will accept international assessment reports from the following:
- WHO and FAO – including the Joint FAO/WHO Meeting on Pesticide Residues (JMPR) and Joint FAO/WHO Expert Committee on Food Additives (JECFA)
- OECD member countries
- Australian regulatory counterparts including the Therapeutic Goods Administration (TGA), Food Standards Australia New Zealand (FSANZ), the National Industrial Chemicals Notification and Assessment Scheme (NICNAS) and the Office of the Gene Technology Regulator (OGTR).
The active constituent or product which is the subject of the international assessment must be identical to the active constituent or product intended for approval or registration, respectively, in Australia.
It would be advantageous if the product which is the subject of the international assessment has the same use pattern as that proposed for registration in Australia. This is not essential as there are some components of the assessment—such as chemistry, mammalian toxicology and ecotoxicology—that are not influenced by the use pattern. In contrast, other component assessments—such as residues and exposure assessments (e.g. dietary, occupational, environment)—are influenced by the use pattern and therefore additional data may be required if extrapolation to the Australian use is not appropriate. In some cases, for example with a JMPR or JECFA evaluation, it may be necessary for submission of additional information on acute toxicity for a product to enable appropriate safety directions to be established.
The international assessment must fulfil the following criteria:
- it must be written in English
- it must contain a full reference list of all the studies cited in the report
- it must be an un-redacted report containing an adequate level of reporting detail:
- an adequate level of reporting detail is defined as that level of detail that allows a regulatory scientist to peer review the assessment and fully understand the basis for any interpretations, conclusions, recommendations or decisions.
While the assessment must be provided in an electronic format that is searchable, and ideally, editable—it does not need to be specifically formatted for the APVMA.
If more than one assessment is available, the most recent comprehensive assessment must be provided in situations where both reports arrive at a similar position. If the conclusion of the two reports diverge then both must be submitted to the APVMA.
All the underlying data or studies relevant to the application must be provided including both published and unpublished studies. All of the original studies cited or evaluated in the international assessment relevant to the application must be submitted as part of an application to the APVMA and consistent with the APVMA’s data guidelines. It is the responsibility of the applicant to source this data if it is not the data owner. The APVMA will have regard to the underlying data and re-evaluate and re-write individual studies where the peer review of the international assessment raises potential divergent scientific interpretations or where there is inadequate detail contained in the international assessment. If the underlying data is not provided or only limited data is provided then the international assessment may have only limited utility to supporting an application and therefore additional data is likely to be required to support an application.
The APVMA will, where ever possible, use the data supplied in an international assessment to inform a regulatory decision, but does not simply adopt the conclusions of that international assessment. Each international assessment must be fit-for-purpose and supported by studies that fulfil our regulatory (data) requirements. In all cases, the APVMA must be satisfied that the proposed use of a product is safe and effective, which is achieved through a scientific assessment process. The use of an international assessment does not remove the obligation of applicants to submit certain studies, data or information nor does it remove the APVMA’s responsibility to undertake an independent scientific evaluation.
The APVMA does not expect the submission of data that would not already be required to support an application for the approval of an active constituent or registration of a product. However, if there are additional data or studies generated since completion of the original studies contained in an international assessment and that could reasonably be expected to be submitted under s160A of the Agvet Code then these must be submitted. Depending on the age of the international assessment, new data could be generated subsequent to its completion. The APVMA expects applicants to provide any new published or unpublished data relevant to the application.
Prior to submission of an international assessment, applicants are encouraged to seek pre-application assistance to ensure the international assessment is fit-for-purpose and that it fulfils all Australian-specific regulatory requirements.
Submission of international assessments and the underlying data should be made via the current processes for lodging an application via the APVMA portal.
Following submission, the APVMA will undertake a fit-for-purpose assessment of the international assessment. A fit-for-purpose assessment ensures that the international assessment:
- is relevant to the active constituent or product intended for approval or registration in Australia – including its identity and use pattern
- fulfils Australian regulatory (data) requirements
- is consistent with Australian technical policy
- uses contemporary scientific methodologies for hazard, exposure and risk assessments
- is supported by all underlying data
- contains an adequate level of reporting detail.
The international assessment will then serve as the foundation document for the APVMA’s regulatory assessment. Individual assessment teams (for example chemistry, residues, toxicology) will consider relevant sections of the international assessment and determine the most appropriate format for their own evaluation on a case-by-case basis.
Applicants should note the submission of an international assessment will not reduce the application fees currently required for particular application types.
It is expected that international assessments will be submitted when there is the potential for efficiencies to be gained in the assessment process. Reductions in timeframes for the overall assessment for modular applications will be considered on a case by case basis and will be discussed as part of pre-application assistance. However it is noted that adjustments to the overall timeframe will still need to consider all component assessments and poisons scheduling requirements, if relevant. For instance, if a single overseas component assessment is submitted for an application with multiple component assessments a reduction in overall timeframe may not be realised.
Submitting an international assessment
If you are considering submitting an international assessment to support a future application, it is important that you read, understand and follow the advice provided in this guidance material. This includes making sure that you:
- have access to an electronic copy of the international assessment and the relevant underlying data
- seek pre-application assistance (PAA) to ensure the international assessment is fit-for-purpose and fulfils Australian-specific regulatory requirements
When you submit your PAA Application via the Online Services portal please attach the international assessment only.
When you submit your registration application via the Online Services portal please attach both the international assessment and the underlying data.
To ensure maximum use can be made of international assessments, they need to be submitted at the time the application is being lodged. However, the APVMA recognises that there may be circumstances where international assessments become available after evaluation has commenced. In these circumstances, the APVMA will consider whether the international assessments will provide any benefit to progress the application depending on where the relevant component assessments are up to.
Accordingly, where you obtain access to an international assessment after your application has been lodged, you should still contact your case manager so the APVMA can consider whether there will still be a benefit to the international assessment being supplied. It is unlikely that timeframe savings will be realised where international assessments are received after evaluation has commenced.
APVMA CEO instructions to staff
The APVMA CEO has issued instructions to staff involved in assessing applications that may use international assessments. A copy of those instructions is provided here for your information.