Signal management

Questions and answers on Implementing Regulation (EU) 2025/1466: Amendment of Regulation (EU) No 520/2012 and Conclusion of the Signal Detection in EudraVigilance Pilot by marketing authorisation holders

Development of a reflection paper on the use of external controls for evidence generation in regulatory decision-making - Scientific guideline

Table of decisions of labelling exemption requests falling under article 63 of Directive 2001/83/EC examined by the Quality Review of Documents (QRD) Group

Demonstration of efficacy for veterinary medicinal products containing anticoccidial substances - Scientific guideline

Orphan designation: Humanised IgG1 monoclonal antibody against adrenocorticotropic hormone Treatment of congenital adrenal hyperplasia, 20/06/2025 Positive

Orphan designation: 4-Amino-1-[(2R,4S,5S)-5-(1,2-dihydroxyethyl)-4-hydroxyoxolan-2-yl]pyrimidin-2-one Treatment of glioma, 20/06/2025 Positive

Orphan designation: empasiprubart Treatment of multifocal motor neuropathy, 20/06/2025 Positive

Orphan designation: Exidavnemab Treatment of multiple system atrophy, 20/06/2025 Positive

Orphan designation: Alpha-N-acetyl glucosaminidase fused to a humanised monoclonal antibody against transferrin receptor Treatment of mucopolysaccharidosis type IIIB (Sanfilippo B syndrome), 20/06/2025 Positive