FAMHP once again spearheads European cooperation by means of the SNSA project

Several years ago, a successful pilot project called Simultaneous National Scientific Advice (SNSA) was launched by the European Innovation Network (EU-IN) and has been operating since then. This project allows researchers to receive national scientific and technical/regulatory advice from multiple national competent authorities simultaneously. This significantly speeds up the advisory procedure, makes it more efficient and harmonises substantive opinions between the authorities involved. The first phase of the SNSA pilot project was launched in February 2020 and the second phase was launched in late 2022. This phase builds on the success of the first phase and optimises the procedure that allowed, among other things, the participation of more than three authorities per application or the participation of the European Clinical Trial Coordination Group (CTCG).

SNSA is open to a variety of applicants, from large pharmaceutical companies to smaller and medium-sized enterprises (SMEs), academic research centres and hospitals. This makes the project accessible to a wide range of researchers from different backgrounds and areas of expertise.

The SNSA pilot project therefore aims to make the quality of scientific and technical/regulatory advice even better. By involving multiple national competent authorities and/or the CTCG at the same time, researchers can draw on different perspectives and expertise. This serves to increase the quality and relevance of the advice provided. In particular, multinational clinical trials can be better designed, thereby enabling the formal review and approval of those trials in different countries to be more coherent and to be carried out more quickly.

Some scenarios for which researchers can apply for SNSA.

For advice on clinical trials to be conducted in multiple EU Member States.
For advice about applying for funding grants to support non-commercial clinical trials.
To obtain information on the early development stage of innovative products for which there is limited regulation.
Prior to clinical trials intended to facilitate the repurposing of authorised medicinal products, such as in the case of new therapeutic indications (drug repurposing).

The pioneering role of the FAMHP

Via the National Innovation Office, the FAMHP has played an important role since the beginning of the SNSA pilot project. The agency was among the 10 Member States that initially set up the project and co-chairs the SNSA working group at the EU-IN together with Germany’s Paul Ehrlich Institute. After three years, Belgium is, after Germany, the country with the most advisory opinions issued by means of the SNSA procedure. Meanwhile, as a result of encouragement from the SNSA working group and of the Belgium’s co-chairmanship, 17 competent authorities have joined the SNSA project and 34 SNSA applications were processed during the first phase. Moreover, a formal collaboration with the Accelerating Clinical Trials in the EU (ACT EU) initiative was launched in 2022 and the second pilot phase of the SNSA pilot project was approved by the Heads of Medicines Agencies (HMA) and launched for the period from the end of 2022 to the end of 2024.

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Christophe Lahorte

Christophe Lahorte, head of the National Innovation Office and Scientific-Technical Advice unit, discusses SNSA’s place in a broader framework:
“In the future, SNSA will be an important complement to and bridge between national scientific advice and the European scientific advice procedures of the European Medicines Agency (EMA). SNSA guides innovators from their translational research (the link between basic and specific medicinal product research) that often happens in one country to the later stages of development that usually take place on a European or international level.

By means of SNSA, we also support the objectives of the ACT-EU initiative and the CTCG to maximize and accelerate multinational clinical trials within the European Union. To this end, the FAMHP works closely with representatives of the EMA and the CTCG in the ACT-EU Priority Action PA7 working group on scientific advice.

I genuinely believe in pooling the multidisciplinary expertise and capacity that exists within the competent authorities of different countries in order to achieve a consolidated and streamlined multi-stakeholder process for SNSA. A great deal of cooperation therefore takes place, but don’t worry, as different opinions are taken into account. Within each SNSA procedure, each participating authority will prepare and discuss their positions on the questions raised by the applicant in order to maximise alignment, before a joint advice meeting is held with the applicant. If divergent positions remain, they will be explained to the applicant in the joint advice meeting and will subsequently be summarised in consolidated minutes of that meeting in order to facilitate further consideration and appropriate follow-up.

Looking to the future, SNSA will hopefully become the one-stop shop, in which we will be able to involve other stakeholders, such as patient organisations and ethics committee representatives. In any case, I am convinced that after 2024, when the second phase of the pilot project ends, SNSA will become an essential part of the way we work.”

Our FAMHP experts

Following his doctorate in pharmaceutical sciences, Christophe Lahorte joined the FAMHP in 2004 as a scientific assessor of clinical trials. In 2009, he became the head of the Scientific Technical/Regulatory Advice and Knowledge Management Unit, which was expanded to become the National Innovation Office and Scientific-Technical Advice Unit.

He is the Belgian representative of the FAMHP to the European Innovation Network (EU-IN) and, as co-chair of the SNSA working group, is also a member of the Priority Action PA7 working group of the ACT-EU initiative on scientific advice. He is also a member and acting member respectively of the Medical Device Coordination Group (MDCG) working groups for “New Technologies” and “Borderline & Classification Working Group”.