News Archiv

EMA releases updated distribution requirements and address list for PSURs

An updated list of addresses and distribution requirements for Periodic Safety Update Reports (PSURs) has been released today by the European Medicines Agency. The list contains...[more]

FI: Fimea reduces paper requirements for electronic submissions

The Finnish Medicines Agency Fimea announced today that the Agency started to accept electronic submissions for new applications as well as variations and renewals without...[more]

European Medicines Agency closes PIM project

The European Medicines Agency announced today the closure of the PIM project as the Agency is currently undertaking a review of its business strategy and IT system requirements in...[more]

EU: New revision of the Post-Authorisation Procedural Advice for the Centralized Procedure released by EMA

The European Medicines Agency has released a new version of the 'Post-Authorisation Procedural Advice Human Medicinal Products' applicable for human medicinal products in scope of...[more]

Australian TGA revises NeeS guidance and seeks comments from stakeholders

The Australian Therapeutic Goods Administration (TGA) has published a revised version of the "Guidance for industry on providing regulatory information in electronic format:...[more]

EU eCTD and NeeS validation criteria updated by TIGes

The EU Telematics Implementation Group for electronic submissions (TIGes) has updated the recently released harmonized validation criteria for eCTD and NeeS (see our related News...[more]

Irish Medicines Board updates Guide to electronic submissions

The Irish Medicines Board (IMB) has updated the national "Guide to electronic Submissions - Human Medicines"

The new version 4 from March 10, 2011 reflects the fact...[more]