首页 >
法规速递
-
Document: IRIS guide for applicants - How to create, submit and manage IRIS applications, for industry and individual applicants-2025/7/25
2025-07-27查看详情 > -
Page: ICH Guideline M13B on bioequivalence for immediate-release solid oral dosage forms - additional strengths biowaiver - Scientific guideline-2025/7/25
2025-07-27查看详情 > -
Document: Overview of comments received on ICH M13B guideline on bioequivalence for immediate-release solid oral dosage forms - additional strengths biowaiver (EMA/CHMP/ICH/85092/2025)-2025/7/25
2025-07-27查看详情 > -
Document: HMPC meeting report on European Union herbal monographs, guidelines and other activities - 07-09 July 2025-2025/7/25
2025-07-27查看详情 > -
Document: Regulatory Procedure Management (RPM) for the Product Lifecycle Management (PLM) - Frequently asked questions-2025/7/25
2025-07-27查看详情 > -
Document: European Union Member State Public Holidays Recorded in CTIS (year: 2026)-2025/7/25
2025-07-27查看详情 > -
Page: Signal management-2025/7/25
2025-07-27查看详情 > -
Document: Questions and answers on Implementing Regulation (EU) 2025/1466: Amendment of Regulation (EU) No 520/2012 and Conclusion of the Signal Detection in EudraVigilance Pilot by marketing authorisation holders-2025/7/25
2025-07-27查看详情 > -
Page: Development of a reflection paper on the use of external controls for evidence generation in regulatory decision-making - Scientific guideline-2025/7/25
2025-07-27查看详情 > -
Document: Table of decisions of labelling exemption requests falling under article 63 of Directive 2001/83/EC examined by the Quality Review of Documents (QRD) Group-2025/7/25
2025-07-27查看详情 >