New draft EU Module 1 eCTD specification 1.4.1 available for consultation

A new draft version of the EU regional eCTD Module 1 specification, version 1.4.1 has been published by the European Medicines Agency today. The draft includes some additional...[more]

Health Canada releases draft guidance on Preparation of Drug Submissions and Applications in the CTD Format for consultation

Health Canada has released the revised draft guidance "Preparation of Drug Submissions and Applications in the Common Technical Document (CTD) Format" for consultation...[more]

EU: Updated requirements from CMDh on electronic and paper submissions for MRP/DCP or National procedures

CMDh has released an updated version of the "Requirements on Electronic submissions (NeeS and eCTD) and paper documentation for New Applications within MRP, DCP or National...[more]

Finnish Medicines Agency reports high percentage of electronic submissions received in the first year

The Finnish Medicines Agency (FIMEA) reports that the acceptance of electronic drug regulatory submissions in Finland has been widely embraced by applicants. Although FIMEA does...[more]

EU CMDh introduces pilot phase for Type IA "supergrouping"

The EU Co-ordination Group for Mutual Recognition and Decentralized Procedures - Human (CDMh) has announced a 6-months pilot phase starting on 1st August 2011 allowing marketing...[more]

2nd Intern. Workshop 'Regulatory Requirements and Current Scientific Aspects on the Preclinical and Clinical Investigation of DDIs'

The 2nd International Workshop on Regulatory Requirements and Current Scientific Aspects on the Preclinical and Clinical Investigation of Drug-Drug Interactions (DDIs) is taking...[more]