News Archiv

CH: Swissmedic updates eCTD guidance documents and eCTD-related forms

The Swiss Drug Regulatory Agency Swissmedic has released updates of their national eCTD guidance documents as well as updated versions of forms for various application types...[more]

EU: New version 4.2.1 of the Light Authoring Tool for PIM released

A new version 4.2.1. of the LAT (Light Authoring Tool) for PIM (Product Information Management) has been released by the EU Telematics Implementation Group for PIM.

Background:...[more]

CMD(h) released updated requirements for electronic submissions and paper documentation for Variations and Renewals within MRP or National procedures

The Co-ordination Group for Mutual Recognition and Decentralized Procedures - Human (CMD(h)) has released the long awaited updated electronic (eCTD or NeeS) and paper submission...[more]

EU: Updated CMD(h) BPG for the submission and processing of variations in the MRP released

The Co-ordination Group for Mutual Recognition and De-centralized Procedures - Human (CMD(h)) has released yet another updated version of the "Best Practice Guides for the...[more]

EU: Updated dossier requirements of the CHMP members released by EMA

The European Medicines Agency (EMA) has released an updated version of the "Dossier requirements of the members of the Committee for Medicinal Products for Human Use...[more]

EU: Proposal of new validation criteria for eCTD and NeeS open consultation

The TIGes Harmonisation Group has released a proposal for new eCTD and NeeS validation criteria that are open for consultation. The release goes inline with the Notice of Intend...[more]

EU: EMA updates PIM Guidance for Applicants

The European Medicines Agency has released an updated version of the PIM (Product Information Management) Guidance for Applicants applicable for the Centralized Procedure.

The...[more]