Closing the gap –

Validating and implementing new approach methodologies in a regulatory context (ValNAM)

A joint initiative by BMFTR (German Federal Ministry of Research, Technology and Space) and ZonMw (The Dutch organisation for knowledge and innovation in health, healthcare and well-being)

The call ValNAM aims for validation of new approach methods in a regulatory context, with the ultimate goal to implement new animal-free, human relevant methods as OECD guidelines or establish qualified models to be used in efficacy testings for new pharmaceuticals.

In this regard projects are expected to increase in technology readiness levels during the duration of the project, thus enabling them to prepare documentation for a timely (2-3 years post project finalisation) regulatory evaluation and approval, if feasible.

For further information regarding the call please refer to the FAQ section below.

We strongly encourage you to use the guidance provided by OECD, ECVAM and various other.

Submission

New Deadline: 26.05.2025

Please use the PtJ Submission Platform to submit your proposal.

DOCUMENTS

• call text
• Dutch national annex renewed (version 25.02.2025)

• German "Richtlinie zur Förderung von Projekten zum Thema 'Validierung und Implementierung humanbasierter neuer Methoden im regulatorischen Kontext'" ("Bekanntmachung" BAnz AT 06.01.2025 B5 und "Änderungsbekanntmachung" BAnz AT 02.04.2025 B3)

• template project proposal

Note for Dutch companies interested in ValNAM

Subordinated loan as equity

In 2017, the Dutch Ministry of Economic Affairs published a circular explaining when a subordinated loan can be regarded as equity. However, this circular was withdrawn on the 13^th of September 2024, following a court ruling at the highest instance on this point. In concrete terms, this means that a subordinated loan can no longer be taken into account in the calculation of equity. This is important for the eligibility of participating companies, as one condition of the GBER is that aid cannot be provided to undertakings in financial difficulties. Dutch companies need to be aware that to receive funding, they need to provide ZonMw with a signed statement that their undertaking is not in “financial difficulty”, as mentioned in Article 2(18) of Commission Regulation (EU) No 651/2014 of 17 June 2014. This statement will be requested when the application is recommended for funding. If this cannot be provided, ZonMw is obliged to refuse the requested grant.