ICH指导原则实施公告情况汇总. 关于我们. 指导原则概况. 质量(Q) 安全性(S) 有效性(E) E1 Clinical Safety for Drugs used in Long-Term Treatment/长期使用的药物的临床安全性. E2A - E2F …

1995年1月6日 · This document aims to develop standard definitions and terminology for key aspects of clinical safety reporting. I also provides guidance on the appropriate mechanism for handling expedited (rapid) reporting, in the investigational (i.e. pre-approval) phase.

ICH TOPIC E2A. This Guideline has been developed by the appropriate ICH Expert Working Group and has been subject to consultation by the regulatory parties, in accordance with the ICH Process. At Step 4 of the Process the final draft is recommended for adoption to the regulatory bodies of the European Union, Japan and USA.

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5)) If unable to submit comments online, please mail written comments to:

ICH E2B (R3) was the first topic harmonized under the new process. An Implementation Guide for E2B (R3) data elements and message specification was developed by the E2B EWG, which uses the ISO/HL7 27953-2 ICSR message exchange standard developed by the SDOs, and E2B (R3) reached Step 4 in November 2012.

ICH Guidelines. All Guidelines; Quality Guidelines; Safety Guidelines; Efficacy Guidelines; Multidisciplinary Guidelines; Index of Guidelines; ICH Standards. MedDRA; CTD; Electronic Standards (ESTRI) Other Work . Reflection Papers & Discussion Groups; Consideration Documents; CIOMS Glossary of ICH Terms & Definitions; ICH PQKM Task Force ...

本指导原则对于申报/批准新化学实体、生物制品、疫苗，已上市产品的重大改变（如，新剂型、新给药途径或新的制造生物制品的生产工艺），以及已上市产品用于新的人群或增加新的适应症或出现一个新的重要安全性问题时最有用。 本指导原则的目的是提出药物警戒计划的结构，和安全性说明来总结在计划中讨论的产品的已确认风险和潜在风险。 指导原则分为以下几个部分： 建议在产品开发早期就有公司的药物警戒专家介入开展上述工作。 应当在早于注册申请的阶段就开始 …

Draft ICH guideline E2C (R2): Periodic benefit-risk evaluation report (PBRER) defines the recommended content and format of a periodic benefit-risk evaluation report (PBRER) and provides an outline of points to be considered in its preparation and submission.

The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is unique in bringing together the regulatory authorities and pharmaceutical industry to discuss scientific and technical aspects of …

At present, some ICH countries and regions accept submission of a Periodic Safety Update Report (PSUR) to fulfil national and regional requirements for periodic reporting on the safety of approved drugs. Although the focus of the DSUR is on investigational drugs, there can be overlap between the content of the DSUR and PSUR, and some