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FDA E2C(R2) Periodic Benefit-Risk Evaluation Report – Questions and Answers

蒋千琴 3/19/2022 浏览 222 FDA 美国

标准简介

E2C(R2) Periodic Benefit-Risk Evaluation Report – Questions and Answers[附网盘链接]是FDA于过去发布的FDA标准，适用于美国。

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E2C(R2) Periodic Benefit-Risk Evaluation Report – Questions and Answers[附网盘链接]
E2C(R2) Periodic Benefit-Risk Evaluation Report – Questions and Answers[附网盘链接](截图)

 

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标准部分原文

Contains Nonbinding Recommendations E2C(R2) Periodic Benefit-Risk Evaluation Report — Questions and Answers 1

Guidance for Industry This guidance represents the current thinking of the Food and Drug Administration (FDA or Agency) on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. To discuss an alternative approach, contact the FDA office responsible for this guidance as listed on the title page. 2

I. INTRODUCTION (1) The ICH guidance E2C(R2) Periodic Benefit-Risk Evaluation Report (PBRER) is intended to be a common standard for periodic benefit-risk evaluation reporting on marketed products 3

among the ICH regions. The ICH E2C(R2) guidance introduced new concepts linked to an evolution of the traditional Periodic Safety Update Report (PSUR) from an interval safety report to a cumulative benefit-risk report. It changed the focus from individual case safety reports to aggregate data evaluation. In addition, the broadened scope increased the need for integrating information within the report. The benefits of harmonizing technical requirements can only be achieved if the guidance is implemented and interpreted in a consistent way across the ICH regions. In November 2012, the ICH Steering Committee endorsed the establishment of an Implementation Working Group (IWG) on E2C(R2) to assist with the implementation of the guidance. The ICH E2C(R2) IWG has prepared this question and answer (Q&A) document to support implementation of the guidance in practice. The Q&A document is intended to facilitate practical implementation of the PBRER, including points to consider in addressing some of the more novel aspects of the new periodic safety report. In general, FDA’s guidance documents do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required. 1

This guidance was developed within the Efficacy Implementation Working Group of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) and has been subject to consultation by the regulatory parties, in accordance with the ICH process. The Q&As in this document have been endorsed by the ICH Steering Committee at Step 4 of the ICH process, March 2014. At Step 4 of the process, the final draft is recommended for adoption to the regulatory bodies of the European Union, Japan, and North America. 2

Arabic numbers reflect the organizational breakdown of the document endorsed by the ICH Steering Committee at Step 4 of the ICH process, March 2014. 3

The ICH E2C(R2) guidance is available on the FDA Drugs guidance Web page at http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm. 1

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