APVMA standard on good regulatory science

This APVMA standard sets out the principles of good regulatory science practice (GRSP) that we follow. The standard is consistent with the principles described in other good practice standards, such as the standards for good manufacturing practice, good laboratory practice and good clinical practice.

Objective

Compliance with the GRSP standard will strengthen the regulatory science quality that underpins our regulatory decisions. A working definition of regulatory science quality is:

Protecting the health and safety of people, animals and the environment and supporting agricultural and livestock industries by making sound science-based regulatory decisions regarding pesticides and veterinary medicines within a framework of accepted international risk assessment and risk management practices.

Science-based regulatory decisions are underpinned by a contemporary understanding of science, the identification and analysis of issues, the use of logic, and the documentation of risk assessment and risk management advice and decisions.

Principles of good regulatory science practice

Quality assurance

  • The APVMA will maintain an externally audited and certified quality system.
  • Our chief regulatory scientists will be responsible for the oversight of quality assurance aspects of GRSP.
  • All staff will have a responsibility for quality assurance, and team managers and executive directors will have line responsibility for the quality of work in their areas.

Personnel and training

  • APVMA staff will receive training in the principles of GRSP relevant to their needs.
  • Our staff will maintain relevant expertise as necessary, or the APVMA will access relevant expertise. Expertise will include knowledge of:
    • the objectives of regulation and the requirements of legislation
    • risk assessment and management
    • data/studies being fit for purpose.
  • APVMA staff, agencies and advice providers will be appropriately involved in technical assessments.
  • There should be no gaps or unexplained or conflicting overlaps in the responsibilities of those concerned with GRSP.
  • Key staff responsible for managing and supervising regulatory science quality will have skills and experience to discharge the responsibility for ensuring that regulatory decisions are underpinned by regulatory science quality.

Standard operating procedures

  • The APVMA will maintain key procedures and work processes, including for the preparation and maintenance of documents, as part of its quality system, through compliance with ISO:9001:2000.
  • Relevant key procedures and work processes will reflect or incorporate scientific and risk analysis principles.

Regulatory decision-making

  • Decisions must be consistent with the APVMA’s governing legislation.
  • Criteria for technical assessments are:
    • data received will be assessed for their fitness for purpose to ensure their suitability for evaluation
    • risk assessment procedures will be appropriate to the particular application being considered and the level of risk involved
    • risk management decisions will be based on risk assessment undertaken
    • scientific issues will be addressed at the appropriate times during evaluation.
  • The APVMA will identify the scientific criteria detailed in governing legislation and use these in technical assessments that support regulatory decisions.

Documentation of technical assessments

  • Technical assessments will include a risk assessment and proposed risk management strategies.
  • Technical assessments will be documented before regulatory decisions are made.
  • Technical assessments will include sufficient detail, which is appropriate to the level of risk for the product group, risk area or issue.
  • The level of risk for a particular product group or risk area will be reflected in technical reports and written advice.
  • Relevant legislative criteria will be identified and addressed in technical reports.

Advice from agencies, technical service providers and international sources

  • Advice provided by agencies, technical service providers and international sources will be critically considered prior to its use in regulatory decision-making.
  • We may have regard to information and data from recognised international sources wherever possible.
  • Information from international sources will be determined to follow the same criteria as required of Australian information and data before its use by the APVMA.

Quality control

  • Different staff will be involved in the technical assessment and the final regulatory decision-making where practical and/or appropriate.
  • A more senior or experienced staff member will peer-review all technical assessments.

Feedback and communication

  • The APVMA will develop and maintain regulatory guidelines.
    • A comprehensive list of guidelines and a guidance agenda will be available in the public domain. The guidance agenda will list the guidelines that we are planning to develop during the financial year.
    • We will follow international, harmonised guidelines where possible or appropriate.
  • We will use existing mechanisms for feedback from stakeholders on regulatory science quality.
  • We will seek stakeholders’ views on a wide range of scientific regulatory issues, most often via the APVMA website.

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