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 …

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 …

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 …

ICH Guidelines. All Guidelines; Quality Guidelines; Safety Guidelines; Efficacy Guidelines; Multidisciplinary Guidelines; Index of Guidelines; ICH Standards. MedDRA; CTD; Electronic …

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 …

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 …

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

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 …