Medical Writing EU Regulations Scientific advice procedures in the EU – an overview ofthe regulatory background

Volume 29, Issue 3 - EU Regulations

Scientific advice procedures in the EU – an overview ofthe regulatory background

Abstract

The prerequisite for obtaining marketing authorisation is an appropriate and robust data package that demonstrates a medicinal product’s quality and its efficacy and safety in the proposed indication. Pharmaceutical companies can face regulatory challenges during product development, especially in case of novel treatment modalities, new substances, or rare indications. To support the generation of the appropriate evidence and accelerate patient access to novel treatments, both the EMA and National Competent Authorities offer scientific advice, which allows companies to obtain guidance from a panel of experts regarding quality, nonclinical, clinical, or other aspects of their development strategy. This review provides regulatory background information on the scientific advice procedure in the EU for medical writers, who may become involved in the preparation of the pertaining briefing package.

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