The European Medicines Agency (EMA) has updated the procedure to request Scientific Advice. Since October 19th, the request for Scientific Advice, Protocol Assistance and Qualification Procedure to the EMA (either initial or follow-up) has to be performed though the IRIS Regulatory & Scientific Information Management Platform.
This online platform was already used to submit regulatory and scientific information to the EMA, such as in the case of Orphan Designation applications. However, the request for Scientific Advice was not linked to IRIS until October this year.
The EMA Scientific Advice provides medicine developers advice on quality, non-clinical, clinical and methodological aspects. The main objective is to generate robust data and minimise major objections in regards to study design during the evaluation of the marketing authorisation application.
At Asphalion we have broad experience and know-how on preparing and presenting Scientific Advice dossiers to EMA and other Agencies. Our professional team will study your project and will elaborate a solid and reliable document with the relevant questions. Throughout 20 years, we have presented Scientific Advice dossiers covering multitude of drug products (small molecules, biologics, ATMPs, medical devices and others) and a variety of indications.