The Finnish Medicines Agency FIMEA has published the requirements on electronic submissions of marketing authorisation material starting from the 1st of January 2011 (see...[more]
The Slovenian drug regulatory agency JAZMP has updated their "Instructions for eCTD and NeeS submissions and validation criteria". The new version 2010_2 from 22...[more]
The European Medicines Agency (EMA) has released an updated version of their Pre-Submission procedural advice for users of the centralised procedure. The procedural advice...[more]
The US Food and Drug Administration has released a Draft version 2.0 of the "Specifications for eCTD Validation Criteria". The specifications are detailing the...[more]
Health Canada has released an updated version of their "Questions and Answers for the Guidance for Industry: Preparation of Drug Submissions in the Electronic Common...[more]
The German Federal Institute for Drugs and Medical Devices (BfArM) has released a new version of the "eValidator" used to validate incoming applications in eCTD and NeeS...[more]
The State Medicines Control Agency (SMCA) of Lithuania has published their national eSubmission Guidance on the website of the agency. According to the Guidance, electronic...[more]
