The information paper explains the current situation about the International Organization for Standardization (ISO) standards related to the identification of medicinal products (IDMP) that are used in E2B(R3) messages (as of 16 February 2021).
Further to the ICH S12 draft document reaching Step 2b of the ICH Process, the Step 2 Informational Presentation developed by the ICH S12 EWG has been finalised.
The European Medicines Regulatory Network's Digital Application Dataset Integration (DADI) project has released a Questions and Answers (Q&A) document with further details about the purpose and scope of the project. The project team aims to follow up in the coming month with further details, including key milestones, the full list of features and the first [...]
The International Council for Harmonisation (ICH) met virtually on 2-3 June 2021 in place of face-to-face meetings that were to take place in Incheon, Republic of Korea. The meeting was preceded by virtual meetings of the ICH Management Committee and MedDRA Management Committee.
Data requested for Variations and/or Renewal Applications in the MRP/DCP which are not stated in the current EU legislation and/or in Volume 2B, Presentation and format of the dossier Common Technical Document (CTD) and/or in the EEA approved Guidelines / Recommendation papers (November 2023) [Track version]
Requirements on submissions for Variations and Renewals within MRP and National Procedures (July 2024) [Track version]
Requirements on Submissions for New Marketing Authorisation Applications within MRP, DCP and National Procedures (July 2024) [Track version]
Data requested for New Applications in the MRP/DCP which are not stated in the current EU legislation and/or in Volume 2B, Presentation and format of the dossier Common Technical Document (CTD) and/or in the EEA approved Guidelines/Recommendation papers (May 2024) [Track version]
The ICH S1B(R1) draft Guideline reached Step 2 of the ICH process on 10 May 2021
CMDh annotated QRD template for MRP/DCP (March 2024) [Tracked]