This page includes information on periodic safety update reports (PSURs), PSUR submission requirements, PSUR single assessment procedures (PSUSAs) and the European Union reference dates (EURD) list.

MDCG 2022-21: Guidance on Periodic Safety Update Report (PSUR), according to Regulation (EU) 2017/745, gives guidance on the content and format of the PSUR. While the PMSR template is simpler and summarizes the results of post-market activities, it also focuses on collecting and analyzing post-market data to ensure ongoing compliance and safety.

PSUR for the PADER/PAER (PSUR waiver). FDA has routinely granted PSUR waivers on the condition that applicants provide the following information:

2022年12月16日 · MDCG 2022-21 - Guidance on Periodic Safety Update Report (PSUR) according to Regulation (EU) 2017/745 - December 2022

2023年4月9日 · A PSUR is a report that provides a detailed evaluation of the safety and efficacy of a medicinal product. It is a requirement for all medicinal products authorized in the European Union (EU), and it must be submitted to the EMA at predefined intervals.

2024年8月3日 · Here we go with the key differences between PBRER and PSUR. Periodic Safety Update Report (PSUR) 1. Purpose: The primary area of a PSUR is the safety of a medicinal product. It aims to comprehensively summarize the drug’s safety profile over a specific period. 2.

2023年1月19日 · This Periodic Safety Update Report (PSUR) applies to [Device Name] and summarizes the results and conclusions of the analyses of the post-market surveillance data. Furthermore, this report provides a rationale and description of …

2023年4月13日 · What is a PSUR? A PSUR is a comprehensive report that provides an evaluation of the safety and performance of a medical device or in vitro diagnostic product over a defined period of time.

2024年5月31日 · In simple terms, a DSUR refers to the clinical safety evaluation of a drug under clinical investigation, and a PSUR refers to the risk-benefit assessment of a drug after it has been authorised. Both documents have different periodicities and submission timings.

2024年12月19日 · This guidance describes the conditions under which applicants can use an alternative reporting format, the International Council for Harmonisation (ICH)3 E2C(R2) Periodic Benefit-Risk Evaluation ...