APVMA Standard on Good Regulatory Science Practice

Introduction

This APVMA Standard sets out the principles of Good Regulatory Science Practice (GRSP) that will be followed by the APVMA. The Standard is consistent with the principles described in other good practice standards, namely Good Manufacturing Practice, Good Laboratory Practice and Good Clinical Practice.

Objective

Compliance with this Standard will strengthen the regulatory science quality that underpins regulatory decisions made by the APVMA.

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, identification and analysis of issues, use of logic, and documentation of risk assessment and risk management advice and decisions.

Principles of good regulatory science practice

  1. Quality Assurance
    1. An externally audited and certified APVMA Quality System will be maintained
    2. The APVMA Principal Scientists will be responsible for oversight of quality assurance aspects of good regulatory science practice
    3. All staff will have a responsibility to quality assurance and Team Managers/Program Managers will have line responsibility for the quality of work in their areas
  2. Personnel and Training
    1. APVMA staff will receive training in the principles of GRSP relevant to their needs
    2. APVMA staff will maintain relevant expertise as necessary; or the APVMA will access relevant expertise. Expertise will include knowledge of
      1. the objectives of regulation and the requirements of legislation
      2. risk assessment and management
      3. data studies being ‘fit for purpose’
      4. the differences between requirements and guidelines
    3. APVMA staff, agencies and advice providers will be appropriately involved in technical assessments
    4. There should be no gaps or unexplained or conflicting overlaps in the responsibilities of those concerned with GRSP
    5. 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
  3. Standard Operating Procedures
    1. Key procedures and work processes including the preparation and maintenance of documents will be maintained as part of the APVMA Quality System underpinned by compliance with ISO:9001:2000
    2. Relevant key procedures and work processes will reflect or incorporate scientific and risk analysis principles
    3. Technical information and data provided for assessment will be assessed against criteria described in publicly available APVMA guidelines and manuals
  4. Regulatory Decision-making
    1. Decisions should be consistent with APVMA governing legislation
    2. Criteria for technical assessments
      1. the appropriate category for applications will be selected
      2. data received will be assessed for its fitness for purpose at screening to ensure its suitability for evaluation
      3. data requirements will be appropriate for the level of risk
      4. risk assessment will be appropriate for the level of risk
      5. risk management decisions will be based on risk assessment undertaken and the active constituent and product type
      6. scientific issues will be addressed at the appropriate time during evaluation
    3. Compliance with governing legislation
      i. scientific criteria detailed in governing legislation will be identified and used in technical assessments that support regulatory decisions
  5. Documentation of Technical Assessments
    1. Technical assessments will include a risk assessment and proposed risk management strategies
    2. Technical assessments will be documented before regulatory decisions are made
    3. Technical assessments will be in sufficient detail appropriate to the level of risk for the product group, risk area or issue
    4. The level of risk for a particular product group or risk area will be reflected in technical reports and written advice
    5. Relevant legislative criteria will be identified and addressed in technical reports
  6. Advice from Agencies, Technical Service Providers and International Sources
    1. Advice provided by agencies, technical service providers and international sources will be critically considered prior to further consultation or use in regulatory decision-making
    2. The APVMA will use international information and data from recognized expert groups wherever possible. In certain circumstances, Australian data must be submitted.
    3. Information from international sources will be determined to follow the same criteria as required of Australian information and data, before use by the APVMA
  7. Quality Control
    1. Separate staff will be involved in the technical assessment and the final regulatory decision-making where practical and/or appropriate
    2. All technical assessments will be peer-reviewed by a more senior staff member
  8. Self Inspection (audits)
    1. APVMA Principal Scientists (or other senior staff) will conduct regular audits of selected technical assessments
    2. A formal Regulatory Science Quality audit program will be maintained
  9. Feedback and Communication
    1. Data requirements and guidelines will be developed and maintained
      1. a comprehensive list of guidelines and a Guidance Agenda will be available in the public domain. The Guidance Agenda will list the guidelines that the APVMA is planning to develop during the financial year.
      2. international harmonized data requirements will be used where possible/appropriate
    2. Existing mechanisms will be used for feedback from stakeholders on regulatory science quality
    3. Awareness of stakeholder views
      1. stakeholder views will be sought on a wide range of scientific regulatory issues, most often via the APVMA website

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