Submission of new test methods to EURL ECVAM
For the evaluation of a method/approach to enter the EURL ECVAM validation process, it needs to be submitted to EURL ECVAM. A method/approach can be any (combination of) method(s) that provide(s) valuable information to answer regulatory questions and/or reduces/replaces animal use for scientific purposes.
The first step is to compile the electronic version of the test presubmission form.
After that, and if we ask the test submitter to do it, they may proceed to step two, which is a complete submission.
The entire EURL ECVAM submission process follows two mandatory steps:
Step 1 - Presubmission
Presubmission is based on the EURL ECVAM Test Presubmission Form (TPF) and is a mandatory requirement for a method/approach to be considered for the EURL ECVAM validation process.
The completed TPF will allow EURL ECVAM to perform a preliminary assessment of the status of development, optimisation, and/or validation of the method/approach and its potential relevance with regard to the Three Rs (replacement, reduction, refinement of animal testing).
At this stage, EURL ECVAM may share the submission with partners such as the PARERE network for consultation. This is with the view of collecting external views on regulatory relevance and prioritisation at an early stage of the process of validation. The prioritisation of methods/approaches to move to step 2 of our submission process and eventually enter the validation process is based on pre-defined criteria and the available capacities that we have in the immediate future. EURL ECVAM cannot guarantee that all submitted test methods can be evaluated internally.
EURL ECVAM will inform the submitter on the outcome of the preliminary assessment of its method/approach based on the TPF.
Only if the method/approach falls within the remit of EURL ECVAM's mission and fulfils the information requirements as outlined in the TPF, EURL ECVAM will invite the submitter to proceed to Step 2.
Step 2 - Complete submission
This step requires the compilation of a detailed test submission template (TST). A pdf version of the TST is provided here for information purposes only, so that submitters can check what EURL ECVAM expects from a full submission already when preparing a presubmission. The Word version of the TST will be provided to submitters at the end of step 1 if the submitter is invited to proceed to step 2. The TST enables the submitter to provide comprehensive information and documentation about the method so that EURL ECVAM can perform a detailed assessment of the submission.
EURL ECVAM will provide the submitter with guidance if needed.
Once the full test submission has been evaluated, EURL ECVAM will provide the submitter with a final decision. The decision will depend on whether the submitted method/approach is considered to be ready for entering the validation process (including peer review by the EURL ECVAM Scientific Advisory Committee; ESAC). If the decision is positive, it will identify at what stage the test method should enter the EURL ECVAM validation process.
Here is some more guidance and explanation of the process:
• Complete submissions must be based on the EURL ECVAM TST and must only be submitted after formal invitation by EURL ECVAM.
• The TST gives further insight to method developers and submitters to understand what is required to describe and validate a method/approach that is suitable for the safety assessment of chemicals.
• The structure of the TST follows the EURL ECVAM modular approach (Hartung et al. 2004) and allows for a comprehensive description of the test method's status with respect to its development, optimisation and/or validation.
• Besides the TST, it is important to have detailed documentation and (raw) data that allow for a full detailed review and that guarantee full transparency and data integrity. An independent audit of the data is advisable to guarantee data quality and integrity.
• A complete submission will not be made available to external persons without the prior consent of the submitter. However, submitters should be aware that in case their method is peer reviewed by ESAC, all peer reviewed documentation linked to the method/approach will be made publicly available through our Tracking System for Alternative methods towards Regulatory acceptance (TSAR) once an ESAC opinion is published. This includes the TST and its annexes, the full test submission assessment report, the standard operating procedures/protocols, (raw) data, ESAC opinion and sub-group report, etc.
• The validation of a method/approach requires long-term dedication, persistence and contributions from various stakeholders.
• In the case where a method/approach qualifies for the validation process, this does not mean that we will automatically validate or peer review the method/approach. There are many steps that we need to go through to validate and peer review a method. This takes time and you will need to work with us throughout this process.
How to submit a non-animal method/approach to EURL ECVAM
- To submit a new method/approach, please fill in the
- Send this file as an attachment to JRC-ECVAM-TEST-SUBMISSIONS
ec [dot] europa [dot] eu (subject: Test%20Presubmission) (JRC-ECVAM-TEST-SUBMISSIONS[at]ec[dot]europa[dot]eu) - Please note that the below privacy policy applies
A list of the test methods assessed by EURL ECVAM and its international partners in the framework of ICATM is available through the Tracking System for Alternative methods towards Regulatory acceptance (TSAR).