Pi­lot phase 2 of the Si­mul­ta­ne­ous Na­tion­al Sci­en­tif­ic Ad­vice (SNSA) starts in 2023

The aim of the pilot project is to make drug developers increasingly aware of the advantages of the SNSA – especially with regard to innovative developments from academia and industry – and to demonstrate the potential added value of the joint consulting concept in order to make the project permanent on the basis of a best-practice model.

The focus of the scientific consultations in phase 2 of the SNSA pilot project is on clinical trials in the EU. The National Competent Authorities (NCAs) involved in the SNSA provide drug developers and sponsors with early access to regulatory information from the EU Member States (MS) where the clinical trials are planned. The experience gained in this pilot phase will be integrated into the further development of the clinical trial process and guidance. The experience gained with the SNSA also supports the goals of the ACT EU Priority Action to promote clinical trials in Europe.

The ACT EU Priority Action is an initiative of the European Commission (EC), the European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMAs) to encourage more clinical trials in Europe. Clinical trials for the purpose of research and drug development are approved in Europe by the national medicines authorities of the EU member states.

When Can a SNSA Be Applied for?

A SNSA can support drug development in the following cases, for example:

• in preparation for clinical trial applications to be conducted in more than one Member State,
• prior to an application for a grant to support non-commercial clinical trials (academic researchers),
• to obtain information in the early stages of the development of innovative medicinal products for which clinical trials are planned.

Background – SNSA-Pilot Project

The EU Innovation Network (EU-IN) initiated the SNSA pilot project in February 2020 to improve early regulatory support for innovative drug development while optimising the consistency of scientific advice.

The applicant usually selects up to three National Competent Authorities (NCAs) in whose member states a multi-center clinical trial will be conducted. In preparation for a SNSA, the experts from the NCAs independently review the submitted standardised consultation documents. Thereafter, the NCAs exchange views and, to the extent possible, consolidate their scientific guidance. Following the SNSA, the applicant receives a reviewed protocol that represents the common and possibly still divergent views of the participating NCAs.

The main features of the optimised SNSA process include:

• participation of further European NCAs in the SNSA process,
• standardised forms for application, briefing book etc.,
• the central e-mail address SNSA@pei.de to initiate the SNSA procedure with reduced administrative burden for applicants,
• a predictable schedule, individually agreed upon before each procedure,
• the involvement of two NCAs per procedure with the possibility of participation of a third NCA with observer status,
• if necessary, participation of a member of the Clinical Trials Coordination Group (CTCG) as an observer at the SNSA meeting,
• possible participation of further medicinal product authorities of Member States in a SNSA procedure, e.g. in case of planned application for clinical trials in several MS.

Background –Scientific Advice of the Paul-Ehrlich-Institut

The Paul-Ehrlich-Institut provides scientific and procedural consulting opportunities to support clinical research and drug development from the initial discovery or generation of a drug substance, through the conduct of clinical trials, to regulatory approval and beyond. Since 2018, the Innovation Office has organised and coordinated the national consultations of the Paul-Ehrlich-Institut.

Contact

SNSA@pei.de