Requesting scientific advice or protocol assistance from EMA

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.

Payment deadline for SAWP Procedures
During the first half of 2025, a transitional approach was applied to help applicants adjust to the new fee regulation.
Starting with the Scientific Advice Working Party (SAWP) meeting in July (7-10 July 2025), only procedures with payments received by the cut-off date (Monday, 7 July) can start during that plenary meeting.
Payments received after the cut-off will automatically move to the next plenary. To avoid delays, we kindly recommend planning ahead and ensuring payment is made on time.

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. To access the platform, see:

• IRIS platform

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 outlined in the guide below before using IRIS to apply for scientific advice.

Quick interactive guide to IRIS registration process

Summary:

Quick interactive guide to IRIS registration process: This presentation is interactive. Please follow the instructions and click on the appropriate icon to be directed to the relevant section.

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:

IRIS guide to registration and RPIs

Reference Number: EMA/444925/2018 Version 2.18 Summary:

Preliminary requirements for all IRIS submissions, including substance and Research Product Identifier registration.

Assigning RPIs helps to make EMA's processes more efficient. It also helps to create a unique platform for all pre-authorisation activities.

Preparatory meetings

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.

Entities not engaged in economical activities are eligible to receive a fee waiver as of 1 January 2025.

For more information see Academia and Fee Regulation working arrangements.

For more information on fees for scientific advice and protocol assistance, see Fees payable to the European Medicines Agency.