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.
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.
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. EMA strongly recommends using its briefing document template for this purpose.
For regulatory guidance on applying for scientific advice, see Guidance for applicants seeking scientific advice and protocol assistance.
For information on submission deadlines, see Scientific advice and protocol assistance: Regulatory and procedural guidance.
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.
Applicants need to use this RPI every time they contact the Agency for any matter related to this specific medicine.
Assigning RPIs helps to make EMA's processes more efficient. It also helps to create a unique platform for all pre-authorisation activities.
EMA formerly referred to these as 'pre-submission meetings'.
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.
EMA holds all preparatory meetings for scientific advice via teleconference since September 2018, following EMA's relocation to Amsterdam and the COVID-19 pandemic. This has not reduced the quality of meetings or applicants’ reported satisfaction with their usefulness.
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).
In the context of preparedness for the UK's withdrawal from the European Union (EU), EMA advises UK-based SMEs to note the deadlines published on the Brexit-related guidance for companies webpage regarding the date of UK's withdrawal from the EU when applying for scientific advice and protocol assistance in order to continue be eligible for financial fee incentives.
For applications with a start of procedure after the published deadline, financial fee incentives for scientific advice will only be accessible through:
- an SME legal entity in the European Economic Area (EEA);
- indirectly through an SME regulatory consultancy established in the EEA;
For more information, see question 9 of Guidance related to the United Kingdom's withdrawal from the European Union with regard to the medicinal products for human and veterinary use within the framework of the Centralised Procedure.
In addition, to be eligible for orphan fee incentives for protocol assistance, an SME needs to meet the following conditions at the start of the procedure:
- a decision by the European Commission on the orphan designation must be in place (product registered in the Community Register);
- the applicant for protocol assistance and the sponsor of the designation must be the same entity and qualified as an SME;
- the indication for which advice is sought must match the orphan designation indication.
For more information, see Brexit-related guidance for companies.