EU Science Hub

Validation and Submission Process

Our mandate and activities (as outlined in Directive 2010/63/EC on the protection of animals used for scientific purposes) cover the entire life cycle of alternative methods, i.e. from development over validation to regulatory acceptance, international recognition and proper scientific use.

At the core of these activities is the EURL ECVAM validation process.

Validation is at the interface between test method development/optimisation and regulatory acceptance/international recognition and ensures a science-based and rigorous evaluation of test methods (Integrated Approaches to Testing and Assessment (IATA) or Defined Approaches (DA)), independent of special interests, establishing their overall performance and fitness for a given purpose, i.e. their scientific validity.

In principle, test methods and approaches could also be validated by other actors than validation bodies such as e.g. test method developers in academia and industry and then reviewed within other neutral (with respect to the test method) processes, such as e.g. the OECD review process within the OECD Test Guidelines Programme.

The EURL ECVAM validation process allows for a consistent execution of all EURL ECVAM validation studies and encompasses four key steps (Figure 1).

Figure 1: The EURL ECVAM Validation Process.

The process (blue) encompasses four key steps. Interactions with stakeholders (EURL ECVAM's Network for Preliminary Assessment of Regulatory Relevance (PARERE) and EURL ECVAM Stakeholder Forum (ESTAF)), International Collaboration on Alternative Methods (ICATM) and European Union Network of Validation Laboratories (EU-NETVAL) are indicated to the left of the process. Key output documents on the right.

The process steps are:

1. Assessment of test method submissions taking stakeholder and ICATM input into account;

2. Planning and conduct of validation studies, possibly in collaboration with EU-NETVAL laboratories;

3. Coordination of independent scientific peer review by the EURL ECVAM Scientific Advisory Committee (ESAC)

4. Development of EURL ECVAM Recommendations on the validity status of test methods taking stakeholder and ICATM input into account.

Step four is further subdivided: 4.1 test method submitters have the possibility to comment on draft EURL ECVAM Recommendations prior to their publication ("Right-to-be-heard process") 4.2 invitation of comments from the general public; 4.3 Finalisation of EURL ECVAM Recommendation, taking into account the comments received. Finally, publication of the EURL ECVAM Recommendations on the website of EURL ECVAM.

During the process, stakeholders, international partners and also test method submitters are involved at key stages, so that their views but also their technical and scientific input is taken into account to the extent possible.

Step 1 - Assessment of proposed (submitted) test methods and priority setting

Step 2 - Planning and execution of validation studies

Step 3 - Coordination of the scientific peer review of validation studies coordinated or evaluated by EURL ECVAM

Step 4 - Development of EURL ECVAM Recommendations on the validity status of test methods