The Paul-Ehrlich-Institut (PEI), Federal Institute for Vaccines and Biomedicines, is taking the lead in the SNSA pilot project for binational scientific advice. SNSA stands for Simultaneous National Scientific Advice. The SNSA procedure offers drug developers from industry and academia the possibility of simultaneously receiving scientific advice from drug authorities in two EU Member States. This saves time and money in the complex drug development process. Due to the pandemic, the first pilot phase was extended until the end of 2021. In addition, all National Competent Authorities (NCAs) are now part of the SNSA; they can choose to participate in an SNSA upon request.
Clinical trials of medicinal products are authorised by the medicines authority of the EU Member State where they are to take place. The evaluation of national marketing authorisation applications and those submitted to the European Medicines Agency (EMA) are carried out by experts from the Member State authorities. Therefore, scientific advice from one or two medicines agencies in Europe provides an effective route to targeted drug development and European marketing authorisation.
EU drug developers will continue to have the opportunity to apply for scientific regulatory advice with the simultaneous involvement of two of their chosen medicines authorities from different Member States – the SNSA – until 31 December 2021. Potential applicants can request detailed information on the SNSA project, such as questions on the general procedure or on the participation of Member State authorities, centrally via the email address SNSA@pei.de from the Paul-Ehrlich-Institut. The Paul-Ehrlich-Institut is providing significant support for the European SNSA pilot procedure.
The SNSA pilot project was initiated in February 2020 by the EU-IN innovation network. The aim is to improve early regulatory support for innovative drug developments while optimising the quality and consistency of consultations. In preparation for a SNSA, the participating national health authorities independently assess the submitted uniform consultation documents and subsequently interact to consolidate their views as far as possible. A protocol is sent to the applicant after the SNSA, reflecting the common views as well as the remaining divergent views.
After a positive evaluation of the first SNSA pilot phase, it is planned in 2022 in a second project phase to expand the pilot project and to involve more than two national medicines authorities in a consultation at the same time. The main task of the pilot project is to identify the need of drug developers for this new format for particularly innovative developments also from the academic sector, to demonstrate the potential added value of the concept and to translate it into a best practice model.
The Paul-Ehrlich-Institut provides scientific and procedural advisory services to support drug development from initial discovery through clinical trials to marketing authorisation and beyond. Since 2018, the Innovation Office at the Paul-Ehrlich-Institut has organised and coordinated national consultations for all products under the Institute's responsibility.
E Mail: SNSA@pei.de
Updated: 29.09.2021
