The ICH Secretariat is pleased to announce the publication of ICH E8(R1) General Considerations for Clinical Studies Introductory Training Video.
Template Cover letter for the submission of variation applications in the MRP (October 2024) [Track version]
Template Letter of Intent for the submission of a type IA super-grouped procedure to the reference authority according to Article 7a of Commission Regulation (EC) No 1234/2008 (October 2024) [Track version]
Added In November 2024 4 November NEW - PSUFU SmAR Fluoroquinolones (for systemic and inhalation use)
Fluoroquinolones (for systemic and inhalation use)Date of publication: 04/11/2024
Best Practice Guides (BPGs) for the Submission and Processing of Variations in the Mutual Recognition ProcedureChapter 1: CMDh BPG for the Allocation of the Mutual Recognition Variation Number for Type I Notifications, Type II Variations, Grouping and Worksharing (October 2024) [Track version]Chapter 2: Procedure for Automatic Validation of Mutual Recognition Procedures for Variations (October 2024) [...]
Guidance applicable from 1 January 2025 Best Practice Guides (BPGs) for the Submission and Processing of Variations in the Mutual Recognition ProcedureChapter 1: CMDh BPG for the Allocation of the Mutual Recognition Variation Number for Type I Notifications, Type II Variations, Grouping and Worksharing (October 2024) [Track version]Chapter 2: Procedure for Automatic Validation of Mutual [...]
EMA/CMDh Explanatory notes on variation application form (Human medicinal products only) (November 2024) [Track version]
Guidance is available on the implementation of the amended Variations Regulation (EU) 2024/1701 for variation applications implemented and submitted from 1 January 2025. This guidance provides instructions on the implementation of the amended Variations Regulation applicable as of 1 January 2025 that includes amendments to the Article 5 procedure, on the annual update for minor [...]
Q&A - List for the submission of variations for human medicinal products according to Commission Regulation (EC) 1234/2008 (October 2024) [Track version]