Scientific Advice

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European Medicines Agency Guidance for Applicants seeking scientific advice and protocol assistance

Published by European Medicines Agency (EMA)ECRIN

Clinical Trials Toolkit

This guidance document addresses a number of questions that users of the scientific advice or protocol assistance procedures may have. It provides an overview of the procedure to obtain scientific advice or protocol assistance and gives guidance to Applicants in preparing their request. This guidance document also explains the scope and nature of scientific advice and protocol assistance. It will enable Applicants to submit requests which are in line with Scientific Advice Working Party (SAWP) requirements and which can be validated and evaluated quickly and efficiently.

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IRDiRC E104 Building Block (National Member State Scientific Advice)

Published by IRDiRCECRIN

Clinical Trials Toolkit

Procedures set up by many (but not all) National Member State to offer scientific advice to developers of new medicines. The procedures can be similar but often less formal than for CHMP scientific advice/protocol assistance at the EMA; they may include written advice and/or face-to-face meetings. The procedures are not limited only to orphan product development and may vary between Member States.

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Joint EMA-FDA Scientific Advice

Published by IRDiRC

Regulatory AffairsEarly Access SupportScientific AdviceJoint EMA-FDA Scientific Advice

The European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA) of the U.S. Department of Health and Human Services have a program to provide parallel scientific advice (PSA) to sponsors. The goal of the PSA program is to provide a mechanism for EMA assessors and FDA reviewers to concurrently exchange with sponsors their views on scientific issues during the development phase of new medicinal products (i.e., new human drugs and Biologics).

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Study Group on Unapproved and Off-label Drugs of High Medical Need

Published by IRDiRC

Regulatory AffairsEarly Access SupportScientific AdviceMHLW or PMDA Regulatory

The objective of the Study Group is to evaluate medical need, investigate necessary studies for market approval, and request company to develop medicinal products to solve the problem of unapproved drug and off- label use with medical need. Public consultations are conducted to gather requests from public.

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