Scientific Advice

What is it for?

It provides a prospective advice on pre-identified specific questions by the applicant regarding their development strategy for Marketing Authorization (MA) and on the most appropriate way to generate robust evidence on a medicine's benefits and risks. It also provides for a formal qualification of innovative methodologies for medicine development. It aims to formally clarify the scientific requirements for MA, e.g. manufacturing, non-clinical and clinical trials, risk-management plans, ways to develop generics, thus ensuring that key aspects of a development plan are in line with regulatory expectations. The advice is provided by the EMA Scientific Advice Working Party (SAWP).

Scientific advice given on the development of orphan designated medicinal products is called protocol assistance.

Who can apply?

This support service is open to any EIC beneficiary working at any stage of development but early advice with subsequent follow-up is recommended. Applications should be limited to the 1) development of any medicinal products or to the 2) development of novel methodologies for drug development not yet integrated in the drug development and clinical management paradigm.

How to apply?

Application is via the online platform IRIS. The applicant organisation, contact point, active substance and medicinal product need to be registered with EMA (refer to the Quick interactive guide to IRIS registration process). In addition, a Research Product Identifier (RPI) needs to be requested, if not available already from prior regulatory interactions. An SME needs to have received the SME status from EMA to benefit from this service, for which certain fee incentives apply. Please check here to find out how to obtain it.

For more information on how to apply please check EMA Guidance for Applicants seeking advice and protocol assistance.

For further information and training on the application please check the recording on two training sessions on 1) How to register for access to IRIS; what research product identifiers (RPI) are and how to use them and on 2) How to submit initial and follow-up scientific advice applications using IRIS.

Timeline and Cost

One can apply any time (no requirement on having an EIC project ongoing or having had one). The SAWP committee meets 11 times a year. The service will be offered upon validation of the application by EMA, which takes roughly 30 days. The entire process from the validation to completion takes between 40-70 days. The costs vary as follows:

90 % fee reduction for SMEs
Free for orphan or paediatric designated products for SMEs and academic applicants
Free for academic applicants on the development of products addressing public health emergency
Free for PRIME designated products
65 % fee reduction for ATMP developed by academic applicants

When fees are determined, the fees charged depend on the type and number of areas of advice (quality, non-clinical, clinical) and on the initial or follow-up nature of the request. For more information on the fees please check here.

Testimonials

Please read here and watch (from 3 h 03 min) the testimonial from the coordinator of the EIC Accelerator PanC-ASAP project. Please also read here and watch (from 3 h 19 min) the testimonial from the coordinator of the EIC Accelerator TREG project.

Learn more

To know more please watch here the recording of the EIC – EMA InfoDay: Regulatory support for the development of innovative medicines and technologies offered on 31/01/2023. The presentation on Scientific Advice starts at 2h 32 min. The slides of the presentation can be found here.

For more information please check:

FAQ

FAQ on the Scientific Advice as part of those Qs asked during the EIC – EMA Info Day will be posted soon at the InfoDay event webpage.

Contact

EMA contact point: scientificadvice@ema.europa.eu or, alternatively, send a question to the European Medicines Agency.