Assessment of SmPC section 5.1: A Guide for Assessors of Centralised Applications - Scientific guideline

EMA’s human medicines committee (CHMP) has drafted a paper to strengthen consistency when assessing  section 5.1 “Pharmacodynamic properties” of Summary of Product Characteristics of medicines, in compliance with the SmPC Guideline. The document is intended to guide assessors in the national competent authorities who are responsible for evaluating marketing authorisation applications. In addition to an internal consultation, an external consultation has been proposed in view of the introduction of few new detailed guidance, e.g. for communicating statistical results. 
 

Keywords: Summary of product Characteristics, SmPC, section 5.1, Pharmacodynamic properties.

Current version - Draft

Draft Assessment of SmPC section 5.1: A Guide for Assessors of Centralised Applications

Consultation dates: 15/12/2023 to 04/03/2024 Reference Number: EMA/CHMP/566497/2023