This content is current only at the time of printing. This document was printed on 8 September 2020. A current copy is located at http://www.gitygostar.com/node/14186
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Guidance for applicants—submission of international data, standards and assessments
We’re reducing regulatory burden for industry by accepting trusted international data, standards and assessments for use in our assessments for agricultural and veterinary (agvet) chemical applications.
Where an agvet chemical is approved under a trusted international standard or risk assessment, we will require additional data only to meet specific legislative requirements, or to enable us to fully consider the risk under Australian environmental conditions and use patterns.
The use of assessments from overseas means that we can deliver a decision on an application sooner, supporting faster access to the market. Contact us via pre-application assistance (PAA) ?to discuss potential time savings and to work out a project plan for how we will use the assessments. You should do this before lodging your product application.
Accepted international data, standards and assessments
We may seek data supplemental to that used in overseas assessments to meet specific legislative requirements, and to enable us to fully consider the risk for Australian environmental conditions and use patterns. We will consider data generated according to the following international guidelines where relevant:
- Organisation for Economic Co-operation and Development (OECD) test guidelines
- International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH) test 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.
We accept the following international standards for use in our assessments:
- Food and Agricultural Organization of the United Nations (FAO) standards and specifications for pesticide active constituents and associated products
- European, British and US pharmacopeial standards for veterinary active and non-active constituents.
We will consider 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).
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 National Industrial Chemicals Notification and Assessment Scheme (NICNAS) 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:
- 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 assessment
For us to accept an international 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 un-redacted 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 however 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 an studies relevant to the application, including published and unpublished studies
- include 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 pattern such as residues and exposure assessments (eg 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.
We will peer review the assessment report and may re-evaluate and re-write individual studies where we arrive at a different scientific interpretation, or there is inadequate detail in the international assessment.??
How to submit an international assessment
Submit the following with your registration application through the online services portal:
- a copy of the label or full information on the use that the assessments addressed
- a copy of the dossier that was submitted to the assessment authority
- a copy of the full assessment report produced by the authority including assessments all of submitted studies. We will not accept summaries or outcomes of assessments
- evidence of ownership of the data and dossier, or a letter of access
- a reasoned justification of the relevance of the assessment to the proposed use in Australia.
- details of any specific conditions on use imposed by the overseas registration and whether they are relevant to the use in Australia
- a declaration that all the data considered by the assessment authority has been submitted to the APVMA
- a listing of any additional data that has been submitted to the APVMA that was not considered in the overseas assessment.
Uploading files to the online services portal
When uploading files to the online services portal you will be asked to specify using the options provided if the file is an international assessment, international data with or without an international assessment, Australian data or another type of file.
If selecting international assessment as file type, before completing the application, you’ll also be asked to:??
- declare whether all of the data submitted to the international body in support of the international assessment is included with your APVMA application, along with any other required data
- specify the country of origin of the international assessment (see above list of countries and official bodies from which we accept international assessments).
Our initial assessment of the data
We will make an initial evaluation of the international assessment to check that it:
- 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.
If we find the international assessment fit for purpose, it will be used as a basis for our Australian assessment.
If an international assessment becomes available after we’ve started our evaluation of an application, we will consider whether the international assessment will provide any timeframe benefit to the application depending on our progress with the relevant component assessments. You should contact your case manager to discuss the likelihood of any time saving.
Please note that submitting an international assessment does not reduce the application fees currently required for particular application types.
How we use the data
We will, where ever possible, use the data supplied in an international assessment to inform a regulatory decision, and 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, we 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 our responsibility to undertake an independent scientific evaluation.
We do not expect data to be submitted that would not already be required to support an active constituent or product application. Additional data or studies generated since completion of the original studies contained in an international assessment that could reasonably be expected to be submitted under s 160A of the Agvet Code must also be submitted. Depending on the age of the international assessment, new data could be generated after its completion. We expect applicants to provide any new published or unpublished data relevant to the application.
Learn more about how we use the data in the APVMA CEO expectations on use of international data standards and assessments.