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Accelerating Clinical Trials in the EU

Scientific advice

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. 

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.

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General publications10 June 2024
Advice on medicines for human use in the EU medicines regulatory network

 

Key updates

The programme also collated updates on other scientific advice procedures, as shown below.

 

Events

News