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.
Legal Disclaimer:
EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.
