EU Simultaneous National Scientific Advice update

The EU Simultaneous National Scientific Advice (SNSA) pilot has been extended to the end of 2021 due to the COVID-19 pandemic, in order to allow additional experience to be gained.

About the SNSA pilot

The EU Innovation Network started a pilot for Simultaneous National Scientific Advice (SNSA) from the National Competent Authorities (NCAs) in February 2020 in order to enable innovators to access scientific advice simultaneously in different EU Member States. The pilot has been extended to the end of 2021.

The concept of SNSA is to offer national scientific advice from different NCAs at an early stage of development at the same time, thereby optimising the quality and consistency of such advice. The NCAs will initially independently review the questions raised and then interact to ensure the maximum possible alignment of their positions prior to a joint advice meeting with the applicant.

Key objectives of the pilot

The key objectives of this pilot project are to explore the needs/demands from the pharmaceutical sector (including large companies as well as local SMEs and academic research centres/hospitals) and to subsequently demonstrate the potential added value of the SNSA concept.

Which are the participating National Competent Authorities (NCAs) in the pilot?

The participating NCAs are:

  • AGES – Austria
  • FAMHP – Belgium
  • SUKL – Czech Republic
  • FIMEA – Finland
  • PEI – Germany
  • OGYEI – Hungary
  • AIFA – Italy
  • NOMA – Norway
  • URPL – Poland
  • AEMPS – Spain

In addition to those NCAs that are already participating in the SNSA pilot, the extension phase envisages the participation of more NCAs on a voluntary case-by-case basis.

Best practice model to optimise resources

In order to optimise resources, the pilot project also aims to develop a best practice model, which will open up opportunities to provide:

  • broader expertise
  • early and simultaneous interaction with NCAs across selected Member States
  • consolidated views and early identification of divergent opinions of the participating NCAs
  • early identification of critical scientific or regulatory issues that may require scientific advice from EMA’s Scientific Advice Working Party (SAWP); EMA’s Emergency Task Force (ETF), etc.
  • knowledge sharing within the EU regulatory network to enhance preparedness for scientific innovation
Where can you find more details about the SNSA pilot procedure and the application process?

Details of the application process and the SNSA pilot procedure are available in a guidance document and any queries in relation to the process and to the selection of Member States should be addressed to SNSA@pei.de or alternatively to the NCA contact points listed in the guidance.

Source: European Medicines Agency