Annual Overviews of GLP facilities – change of access

Annual Overviews of GLP facilities – change of access Whilst NATA is predominantly known as Australia’s laboratory accreditation authority, they are also the national Compliance Monitoring Authority (CMA) for OECD Good Laboratory Practice (GLP). This is detailed in NATA’s Memorandum of Understanding (MOU) with the Commonwealth Government of Australia.

One the main objectives of OECD GLP compliance monitoring is to ensure that test data on chemicals provided to regulatory authorities for purposes of assessment and other uses related to the protection of human health and the environment are of high quality, valid and reliable. Receiving authorities (i.e. regulatory authorities receiving GLP data) are expected to ensure that the data they receive was generated in compliance with the OECD Principles of GLP. They can only do so by verifying the OECD GLP status of the test facility at the time that the study was conducted.

Under the OECD Council Acts related to the Mutual Acceptance of Data (MAD), all OECD members (including NATA) and full adherents to MAD are required to provide the OECD Secretariat with an Annual Overview of test facilities inspected. This includes:

  • Trading name; 
  • Address; 
  • Facility and site numbers;
  • Types of studies inspected;
  • Date of recognition;
  • Date of last NATA assessment or study audit;
  • Compliance status at time of the assessment or study audit;
  • If studies were found to be non-compliant.

Regulators, both domestic and overseas, are now able to access the Annual Overviews of GLP facilities via a password protected section of the OECD website. In addition, the Annual Overview will now also indicate if any studies were found to be non-compliant in that year.

Please note that specific information about non-compliant studies and facilities is not listed in the Annual Overview. This information is, however, exchanged between CMAs who then advise their relevant regulatory authorities. In Australia that is the Therapeutic Goods Administration (TGA), Australian Pesticides and Veterinary Medicines Authority (APVMA), National Industrial Chemicals Notification and Assessment Scheme (NICNAS) and Department of Environment and Energy.

Authorised Representatives formally consent to NATA disclosing this information to facilitate the above requirements by signing the relevant section of the Application for Accreditation or Change of Authorised Representative form. It is also re-iterated in the OECD GLP Program Application Document, notification letters and other NATA communication.

If you have any questions regarding this please contact Ms Louise Calder, GLP Program Adviser and Accreditation Manager