The programme aims to reinforce scientific advice coordination between clinical trial approval and clinical trial design in the European medicines regulatory network, so as to facilitate the development of safe and effective medicines for human use.
This will further foster collaboration between the European Medicine Agency's (EMA) Scientific Advice Working Party (SAWP) or Emergency Task Force (ETF), on one side, and the Heads of Medicines Agencies' Clinical Trial Coordination Group (CTCG) and EU Innovation Network's simultaneous national scientific advice (SNSA) pilot on the other side.
In order to clarify the scope of scientific advice activities, ACT EU mapped information on voluntary procedures available within the European medicines regulatory network.
Mapped information on current voluntary procedures
With a view to clarifying the scope of current scientific advice activities, ACT EU has mapped information on current voluntary procedures available from European Union (EU) regulators on medicines for human use, and collated this information in the form of questions and answers.
It should be noted that the scope of scientific advice options overlaps significantly with the type of product and applicant being important factors for selecting the most optimal option; e.g. products intended for a single or limited number of EU Member State(s), applicants operating nationally, including academic ones opting for national scientific advice.
Options and further information | Provider | Scope |
Nationally | National innovation offices | Regulatory support to innovation by: Acting as an initial entry point for engagement with national competent authorities to encourage dialogue and the use of available regulatory supports from an early stage of development. While all developers may engage with national innovation offices, there is a particular emphasis on academic researchers and small and medium-sized enterprises (SMEs). Providing advice to developers on scientific, technical and regulatory aspects relating to innovative products or associated technologies falling within the remit of the national competent authority particularly in the early stages of development. Sharing information in relation to the various regulatory supports that are available to innovators at both national and European level and how these can be accessed. |
Centralised support Innovation in medicines | European Medicines Agency (EMA) (europa.eu) | Innovation Task Force (ITF)
| Early dialogue with applicants, in particular micro, small and medium-sized enterprises (SMEs) and academia to proactively identify scientific, legal and regulatory issues of emerging therapies and technologies. Advice on eligibility to EMA procedures relating to research and development, with the Committee for Medicinal Products for Human Use (CHMP), the European Commission and National Competent Authorities (NCAs) as appropriate, in the case of uncertainties or borderline issues concerning medicinal products. For emerging therapies and technologies and borderline products for human for which there is no established EMA scientific, legal and regulatory experience. |
Centralised support | Small medium enterprise (SME) Office | Procedural and administrative assistance, support on a regulatory strategy of a medicinal product development and how to navigate the range of procedures and incentives available at EMA. |
Centralised support Emergency Task Force (ETF) | European Medicines Agency (europa.eu) | Committee for Medicinal Products for Human Use (CHMP) on the basis of recommendations by the Emergency Task Force (ETF) | Provision of early guidance on a medicine development (when not yet suitable for scientific advice). For new or repurposed human medicines that are intended to treat, prevent or diagnose a disease causing a declared public health emergency. On a case-by-case basis, the ETF also provides advice on medicines targeting selected pathogens that can potentially cause a public health emergency. |
Centralised support Paediatric medicines: Research and development | European Medicines Agency (europa.eu) | Paediatric Medicines Office | Procedural advice on application for a paediatric Investigation plan (PIP), deferral, waiver or modification. |
Note: Informal processes refer to processes which do not lead to an adopted regulatory opinion.
Options and further information | Provider | Scope |
National scientific advice | Scientific advice/clinical trial office in the Member States. | Please contact local national competent authority in the member state. |
Simultaneous National Scientific Advice (SNSA) Heads of Medicines Agencies: EU-Innovation Network (EU-IN) (hma.eu) | Innovation office/clinical trial office/Scientific advice office in the Member States. | SNSA is intended to be used in situations where an applicant wishes to obtain national scientific advice from more than one NCA at the same time. In conjunction with ACT EU, this phase of the SNSA pilot will have a specific focus on scientific advice to facilitate clinical trials within the EU. |
Centralised Scientific advice Scientific advice and protocol assistance | European Medicines Agency (europa.eu) | Committee for Medicinal Products for Human Use (CHMP) on the basis of recommendations by the Scientific Advice Working Party. | Product- and indication-specific prospective advice on any aspect of medicines development for a marketing authorisation, including details of paediatric developments (ideally following an agreed paediatric investigation plan). Protocol assistance (which is centralised scientific advice for orphan products) may include questions on demonstration of significant benefit (against other available therapies) as an orphan designation criterion. Centralised scientific advice excludes: advice on a specific clinical trial application (CTA), eligibility to accelerated assessment, compassionate use, pre-assessment of data for a marketing authorisation application, products addressing public health emergencies. |
Centralised Scientific advice for medicines targeting a (potential) public health emergency Scientific advice and protocol assistance | European Medicines Agency (europa.eu)
| Committee for Medicinal Products for Human Use (CHMP) on the basis of recommendations by the Emergency Task Force (ETF)
| Product- and indication-specific prospective advice on any aspect of medicines development for a marketing authorisation, including details of paediatric developments. For medicines addressing declared and potential public health emergencies. Includes involvement of Clinical trial Advisory Group (CTCG), Clinical Trial Advisory Group (CTAG) and Member State (MS) representatives where the trial is expected to be conducted to align with national advice and facilitate CTA during emergencies. Support to clinical trial sponsors as per article 15(2)c of Reg 123/2022 to facilitate CT application and approval and the conduct of large multinational trials. This involves rapid scientific discussion and feedback on the clinical Trial protocol and involvement of CTCG/CTAG and MSs where the trial is expected to be conducted. |
Centralised support PRIME scheme (PRIority MEdicines) PRIME: priority medicines | European Medicines Agency (europa.eu) | European Medicines Regulatory Network | Enhanced support for the development of medicines that target an unmet medical need, and offer a major therapeutic advantage over existing treatments or benefit patients without treatment options. |
Options and further information | Provider | Scope |
Nationally | National innovation offices | Regulatory support to innovation by: Acting as an initial entry point for engagement with national competent authorities to encourage dialogue and the use of available regulatory supports from an early stage of development. While all developers may engage with national innovation offices, there is a particular emphasis on academic researchers and small and medium-sized enterprises (SMEs). Providing advice to developers on scientific, technical and regulatory aspects relating to innovative products or associated technologies falling within the remit of the national competent authority particularly in the early stages of development. Sharing information in relation to the various regulatory supports that are available to innovators at both national and European level and how these can be accessed. |
Centralised support Innovation in medicines | European Medicines Agency (europa.eu) | Innovation Task Force (ITF)
| Early dialogue with applicants, in particular micro, small and medium-sized enterprises (SMEs) and academia to proactively identify scientific, legal and regulatory issues of emerging therapies and technologies. Advice on eligibility to EMA procedures relating to research and development, with the Committee for Medicinal Products for Human Use (CHMP), the European Commission and national competent authorities (NCAs) as appropriate, in case of uncertainties or borderline issues concerning medicinal products. For emerging therapies and technologies and borderline products for which there is no established EMA scientific, legal and regulatory experience. |
Centralised Qualification advice | Committee for Medicinal Products for Human Use (CHMP) on the basis of recommendations by the Scientific Advice Working Party | Advice to support the qualification of innovative development methods (rather than a specific product) for a specific intended use in the context of research and development of pharmaceuticals. Qualification opinion further to assessment of data on innovative development methods for a specific intended use in the context of research and development of pharmaceuticals. |
Broad centralised scientific advice Research and development | European Medicines Agency (europa.eu) | Committee for Medicinal Products for Human Use (CHMP) on the basis of recommendations by the Scientific Advice Working Party or the Emergency Task Force (ETF) | Issues affecting multiple products and/or indications (e.g. Quality changes, platform trials). Should the need arise, the ETF can advise the CHMP on similar scientific advice procedures for emergencies. |
Latest updates
The programme also collated updates on other scientific advice procedures, as shown below.
For scientific advice provided by SAWP and the Committee for Medicinal Products for Human Use (CHMP), EMA clarifies which questions are outside the scope through the following resources:
EMA's ETF and CHMP also provide centralised scientific advice for medicines targeting a declared or potential public health emergency, and for preparedness, based on articles 15 and 16 of Regulation 123/2022.
For related guidance for developers, see:
The EU Innovation Network (EU IN) consulted ACT EU to launch the second phase of its pilot on simultaneous national scientific advice (SNSA). The launch took place in November 2022.
For more information on SNSA's purpose, and to access relevant documents such as guidance and application forms, see: Heads of Medicines Agency: Simultaneous national scientific advice (SNSA) pilot phase 2 launch.
The SNSA pilot focuses specifically on scientific advice to facilitate clinical trials within the EU.
The optimised SNSA process will continue to complement and provide a bridge between purely national scientific advice and centralised European scientific advice procedures from EMA.
The pilot is expected to inform the development of a final consolidated process for the provision of clinical trial-related advice.
