The European Medicines Agency (EMA) provides scientific advice to medicine developers, to support the timely and sound development of high-quality, effective and safe medicines. Applicants wishing to apply should follow the guidance in this section.
At any stage of a medicine's development, the developer can ask for scientific advice on the best methods and study designs to generate robust data on how well a medicine works and how safe it is.
Apply using the 'IRIS' platform
Medicine developers should use EMA's secure online IRIS platform to request scientific advice, protocol assistance or qualification of novel methodologies for medicine development from EMA:
The IRIS platform provides a single space for applicants and EMA to submit requests, communicate, share information and deliver documents concerning a scientific advice procedure.
Medicine developers first need to complete the registration steps set out in the Quick interactive guide to IRIS registration process before using IRIS to apply for scientific advice.
The IRIS platform homepage also provides guidance on registering and using IRIS to make regulatory submissions.
Scientific advice applicants need to upload a draft briefing document introducing the medicine under development and the applicant's questions and positions in IRIS at the time of applying. It is mandatory to use the CHMP scientific advice/protocol assistance briefing document template.
For regulatory guidance on applying for scientific advice including information on submission deadlines, see Scientific advice and protocol assistance.
Research product identifier
EMA uses research product identifiers (RPIs) to track medicines through pre-authorisation procedures.
The RPI replaces the previously-used unique product identifiers (UPIs). EMA has converted previously assigned UPIs into RPIs.
Companies and individuals that approach EMA for the first time with a new medicinal product and do not have a previously assigned UPI/RPI, will need to request a new RPI via the IRIS platform.
Applicants need to use this RPI every time they contact the Agency for any matter related to this specific medicine.
For guidance, including on obtaining any preliminary registration, see the
Assigning RPIs helps to make EMA's processes more efficient. It also helps to create a unique platform for all pre-authorisation activities.
The Agency offers assistance to applicants in putting their scientific advice or protocol assistance requests together through preparatory meetings. These meetings are free of charge and held via teleconference.
Preparatory meetings are an opportunity for companies to:
- introduce their proposed development programme and receive feedback from Agency staff;
- receive feedback on the list of questions to be included in the request for scientific advice, with a view to obtaining satisfactory answers;
- identify additional issues to be included in the request for scientific advice;
- obtain more detailed information concerning the procedure for obtaining scientific advice or protocol assistance;
- ask regulatory questions that are outside the scope of scientific advice;
- establish contact with Agency staff involved with the application.
The meetings also allow EMA to determine if there is a need for additional expertise at an earlier stage in the procedure.
Preparatory meetings are particularly important for first-time users of these procedures, for micro-, small- and medium-sized enterprises (SMEs), and for companies seeking general advice on specific types of medicinal products or therapies.
The information provided by the applicant provides the basis for the meeting discussion. The scientific opinions expressed by EMA participants represent their individual views and do not represent the final opinion of the Scientific Advice Working Party (SAWP) or Committee for Medicinal Products for Human Use (CHMP).
Fees and fee reductions
EMA charges a fee for scientific advice, which varies depending on the scope of the advice.
Reductions apply for certain types of medicines and applicants, including a 75% fee reduction for medicines for orphan medicines and a 90% fee reduction for SMEs.
A full waiver applies by default to scientific advice applications on clinical trials and clinical trials protocols for medicines intended to treat, prevent or diagnose a declared public health emergency.
Applicants from the academic sector are eligible to receive free protocol assistance for developing orphan medicines as of 19 June 2020. For more information see Academia and Fees payable to the European Medicines Agency.
For more information on fees for scientific advice and protocol assistance, see Fees payable to the European Medicines Agency.