News Archiv

BfArM widens scope for accepting electronic-only submissions

The German Federal Institute for Drugs and Medical Devices (BfArM) will widen it's scope for accepting electronic-only submissions for human medicines starting October 08 this...[mehr]

Health Canada revises eCTD Module 1 guideline

Health Canada has revised their national guidance document "Creation of the Canadian Module 1 Backbone". The updated version has been published on September 07 and will...[mehr]

EMA releases another update of the CHMP dossier requirements

The European Medicines Agency (EMA) has released another update of the "Dossier requirements for Members of the Committee for medicinal products for human use (CHMP)"....[mehr]

FDA releases final version 2.0 of the US eCTD Module 1 specification

The U.S. Food and Drug Administration (FDA) has released the final version 2.0 of the regional US eCTD Module 1 specification files.

The Module 1 eCTD specification files have...[mehr]

FDA updates Study Data Specifications and Transmission Specifications

The U.S. Food and Drug Administration (FDA) has released an updated version 2.0 of their Study Data Specification, dated July 18, 2012.

The specification document was reorganized...[mehr]

EMA announces full availability of electronic application forms; udpated eSubmission gateway Q&A

After succesfully completing the previous pilot phase, the European Medicines Agency (EMA) has recently announced the full availability of the electronic application forms for...[mehr]

EMA updates Post-authorisation procedural advice and CHMP dossier requirements

The European Medicines Agency (EMA) has released another update of the "Post-Authorisation Procedural Advice" for users of the EU  Centralized Procedure. The new...[mehr]