News Archiv

EU: PIM Data Exchange Standard (DES) FAQ updated

The PIM (Product Information Management) Data Exchange Standard (DES) Frequently Asked Questions (FAQ) have recently been updated by the European Medicines Agency (EMA). The...[more]

Presentation: Realizing eCTD capabilities with external Providers - DIA, December 2010

Sibylle Teuchmann, Co-founder and Managing Director of Exalon gave a presentation at DIA`s 11th Conference on European Electronic Document Management which took place from...[more]

AU: TGA releases new transitional version of CTD Module 1 to be used from March 2011 onwards

The Australian Therapeutic Goods Administration (TGA) has posted a new transitional version of the Common Technical Document (CTD) Module 1 for Australia. This new version from...[more]

Updated CHMP Dosssier requirements posted by European Medicines Agency

The European Medicines Agency has posted an updated list of Dossier requirements for the CHMP members. The list is applicable for medicinal products for human use in the...[more]

EMA releases updated EU regional Q&A and Electronic Submission Specifications & Guidances Change Request Document

The European Medicines Agency (EMA) has released an updated version (Version 1.24) of the "EU Region Question & Answer and Electronic Submission Specifications &...[more]

CMD(h) posts 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 posted another updated version of the "Requirements on Electronic submissions...[more]

AU: TGA released draft NeeS guidance for human medicinal products

The Australian Therapeutic Goods Administration (TGA) has released a guidance on electronic prescription medicine submission dossiers entitled "Guidance for industry on...[more]