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.
Consolidated advice pilots
The pilots enhance the coordination within the European medicines regulatory network (EMRN) to offer applicants harmonised advice on how to improve the quality of their applications for marketing and/or clinical trial authorisation(s).
In line with EMRN's strategic goals and ACT EU's vision to improve the EU environment for clinical trials, the pilots aim to facilitate the development of safe and effective medicines to the benefit of patients and healthcare in the region.
This pilot provides consolidated scientific advice to support applicants in the submission of marketing authorisation and/or clinical trial applications in the EU.
The advice is offered via increased coordination between the Scientific Advice Working Party (SAWP) and the Clinical Trials Coordination Group (CTCG).
This pilot provides consolidated technical, regulatory advice on the dossier of a clinical trial application (CTA) prior to its submission in the Clinical Trials Information System (CTIS).
The pilot is coordinated by the Clinical Trials Coordination Group (CTCG).
Mapped information on current voluntary procedures
With a view to clarifying the scope of current scientific and regulatory advice activities, the ACT EU initiative has mapped information on current voluntary procedures available from EU regulators on Medicines for human use and collated this information in the form of questions and answers.
The scope of scientific advice options overlaps significantly, with the type of product and applicant being important factors for selecting the 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.
Key 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.
