Around the Globe

European Regulatory Network Piloting New Regulatory Tool
Simultaneous National Scientific Advice
Thomas Kühler
Sanofi R&D

he significance that sponsors place on soliciting input on their development projects from regulators is evidenced by the steadily growing number of Scientific Advice procedures given by, for instance, the European Medicines Agency (EMA) or US Food & Drug Administration (FDA). Indeed, EMA reported they granted 466 Scientific Advice and follow-up requests in 2018 (the 2019 report has not yet been published) compared to 264 in 2008.

Several studies have shown that (innovative and novel) therapeutic principles will have a higher chance of meeting regulatory requirements, and hence be approved, when the sponsor has sought and obtained Scientific Advice. Hence, Scientific Advice does ultimately benefit society and patients by making a broader pharmaceutical armamentarium available, delivering value beyond regulators and sponsors.

In the distributed regulatory network of the EU, sponsors sometimes opt for National Scientific Advice with a single Member State Agency, or a few select national Agencies, before pursuing a Central Scientific Advice with the EMA. These dialogues provide means for the sponsor to create awareness with the regulator on their current development projects and specific challenges associated with them; offer a platform to progress the regulatory science discussion; and may even create an appetite from the agency to later bid for the EMA rapporteurship or co-rapporteurship once the marketing authorization application is filed.

The EU regulatory network, jointly sponsored by the Heads of Medicines Agencies and the EMA, now takes another step with its aim of streamlining and coordinating National Scientific Advice by launching a pilot on Simultaneous National Scientific Advice (SNSA). This is a complementary tool to the established regulatory national or central (EMA) Scientific Advice procedures, with the hoped-for benefits of saving time, avoiding duplication of effort, and preserving human and financial resources. The pilot started on 1 February 2020 and will run for approximately one year, at which time it will be evaluated to determine if there was sufficient demand and value added.

Simultaneous National Scientific Advice Pilot Objectives

The chief objectives of the pilot are a) to create a coordinated approach involving several national competent authorities on questions and data packages (similar to the procedure for National Scientific Advice); b) provide an opportunity to discuss issues in a concerted fashion across selected Member States and hence obtain a consolidated view (or identify divergent opinions) of participating national regulators; and c) identify issues of scientific or regulatory nature that may merit Scientific Advice at the central EMA level.

The pilot is open to all types of products, including drug-device combinations, but excludes HTA and reimbursement aspects. Big pharmaceutical houses, small and medium sized enterprises, and academic institutions are invited to apply for the SNSA procedure. The pilot’s scope, however, is rather limited because the applicant can propose only two national competent authorities per SNSA, one of which will meet the applicant face-to-face while the other will join by telephone or video conference. This limitation may lessen the popularity and uptake of the SNSA because sponsors sometimes like to solicit input from more than two national agencies.

At the time of this writing, eight of the more than thirty European network regulators (comprising 28 Member State and three European Economic Area National Competent Authorities) have committed to participate in this SNSA pilot: AEMPS in Spain, AGES in Austria, AIFA in Italy, BfArM and PEI in Germany, FAMHP in Belgium, FIMEA in Finland, MHRA in United Kingdom, NOMA in Norway, OGYEI in Hungary, SUKL in Czechia, and URPL in Poland.

In closing, any interested party could apply for an SNSA by an informal letter, or by using an existing national scientific application form, to one of the two selected national regulators. The SNSA procedure is detailed in a recent guidance.