Health Canada has further increased it's scope of submissions that are accepted in eCTD-only format. A corresponding Notice has been released yesterday on Health Canada's website....[more]
The European Medicines Agency (EMA) has updated their "procedural advice" guidance documents for user of the centralized procedure in the "pre-submission" and...[more]
A new version of the "EU Region Question & Answer and Electronic Submission Specifications & Guidances Change Request Document" has been released today by the...[more]
A new version of the "eValidator" eCTD / NeeS validation software used by German BfArM (developed by Lorenz Life Science, wwww.lorenz.cc) has been released. The new...[more]
The Danish Medicines Agency (DKMA) has announced that starting from June 2011, all company authorisations will be issued in electronic form as a signed PDF file. Company...[more]
The Australian Therapeutic Goods Administration (TGA) has released a new guidance document "Paper format: Requirements for industry for providing regulatory information....[more]
The Co-ordination Group for Mutual Recognition and Decentralized Procedure - Human (CMD(h)) has released an updated version (Rev 6, April 2011) of the table listing additional...[more]
