TSAR (EURL ECVAM Tracking System for Alternative methods towards Regulatory acceptance) provides an overview of alternative (non-animal) methods that have been proposed for regulatory safety or efficacy testing of chemicals or biological agents such as vaccines. It tracks the progress, in a transparent manner, from proposal of an alternative method for validation through to its final adoption by inclusion into the regulatory framework (e.g. EU legislation, Organisation for Economic Collaboration and Development (OECD) Guidelines or Guidance documents, European Pharmacopoeia, International Conference on Harmonisation of technical requirements for registration of pharmaceuticals for human/veterinarian use (ICH), International Organization for Standardization (ISO) etc.).
TSAR provides information on the method's validation status, indicates the stages it has reached in terms of acceptance as a recognised test method for use in various sectors together with a method summary description. Where available, TSAR also includes relevant records and documents associated with a method linked to the different steps of the entire process: submission, validation, peer-review, recommendations and regulatory acceptance including international standards represented in the tracking system.
TSAR was developed by the European Commission Joint Research Centre's EU Reference Laboratory for Alternatives to Animal Testing (EURL ECVAM) to disseminate information on methods being considered by member and observer organisations of the International Cooperation on Alternative Testing Methods (ICATM) representing the EU, Canada, USA, Republic of Korea, Brazil, China and Japan. In particular, the ICATM includes the following member organisations: EURL ECVAM (EU), Health Canada (CA), ICCVAM/NICEATM (US), KoCVAM (KR), and as observers BraCVAM (BRA), authorities in China as well as JaCVAM (JP).
The TSAR homepage provides access to a group of featured test methods and, on the main toolbar, a link to the Test Methods Tracking page, where all the methods available through TSAR can by searched by using various search criteria. By default all Test Methods are displayed according to the last update. A box for each test method shows some basic information. The horizontal bar gives a quick overview of the process to approval, from submission, validation, peer review, and issuing of recommendations, to regulatory acceptance: green labels indicate finalised steps; blue labels indicate on-going steps, grey labels are shown when a corresponding step hasn't started yet or is not applicable for the method and a black label indicates that a method did not progress further. By selecting the method name access is provided to its individual method page and track its progress in detail.
This first release of the revised TSAR includes the majority of methods submitted to the EURL ECVAM back until 2008. The remaining methods will progressively be made available for public access together with those from all ICATM partners.
For the methods where no further action has been taken over the past five years and/or contact with the submitter was lost, the following information is shown: on hold-pending further information.
The Notify Me option that allows users to provide contact details for the automatic update on the method progress, will be made available in the near future.
NOTE: As far as the EU legislation is concerned, it is worth mentioning that not all alternative methods will or need to be included in the Test Methods regulation (TMR, Commission Regulation (EC) No 440/2008 of 30 May 2008), as this Regulation only contains relevant methods for the assessment of properties of chemicals that fall directly under its remit (see below some links to relevant legislation that contains data requirements). In addition to TMR, a number of methods are used on a day to day basis in a regulatory context through other product related guidance, as part of intelligent testing strategies or as pre-screening methods. Regardless of the way of implementation, they all contribute to the replacement; reduction and refinement of the use of animals in scientific procedures and their progress within the validation and acceptance process are made available through TSAR.