The content of section 5.1 (“Pharmacodynamic properties”) of the Summary of Product Characteristics (SmPC) is proposed by the applicant or marketing authorisation holder and it is assessed by the rapporteur/s. The final content is discussed by the Committee for Human Medicinal Products (CHMP) and remains a case-by-case decision.
The SmPC Guideline [1] states: “It may be appropriate to provide limited information relevant to the prescriber, such as the main results (statistically compelling and clinically relevant) regarding prespecified endpoints or clinical outcomes in the major trials and giving the main characteristics of the patient population. Such information on clinical trials should be concise, clear, relevant and balanced and should summarise evidence from relevant studies supporting the indication.”
The CHMP has frequent discussions on section 5.1, e.g. concerning what trials and what information to include. This document aims to provide tools and details for the drafting and assessment of this part of the SmPC in accordance with the SmPC guideline.
In general, section 5.1 should be limited to the indication/s, population and posology that are authorised. No information should be given on indications or populations that were not applied for or for which there was not a positive opinion. Section 5.1 may provide further information on the authorised indication (e.g. clarification of what staging system for the disease was used). There should be no information on off-label use