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TIGes announces start of the eCTD Version 4 feasibility test

The Telematics Implementation Group for electronic submissions (TIGes) has announced the start of the eCTD Version 4 feasibility test. Prior to that it was decided that the...[mehr]

Saudi SFDA publishes roadmap to eCTD, GCC releases Module 1 specification

The Saudi Food & Drug Authority (SFDA) published some further information regarding their road map towards electronic submission implementation:

Starting from December 20,...[mehr]

AU: TGA releases guidance for paper dossiers using eCTD or NeeS as the source

The Australian Therapeutic Goods Administration (TGA) has released a new guidance document "Paper format: Requirements for industry for providing regulatory information....[mehr]

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:...[mehr]

AU: TGA releases new transitional version of CTD Module 1 to be used from March 2011 onwards

The Australian Therapeutic Goods Administration (TGA) has posted a new transitional version of the Common Technical Document (CTD) Module 1 for Australia. This new version from...[mehr]

AU: TGA released draft NeeS guidance for human medicinal products

The Australian Therapeutic Goods Administration (TGA) has released a guidance on electronic prescription medicine submission dossiers entitled "Guidance for industry on...[mehr]

Global: Controlled Vocabulary updated for RPS R2 DSTU by HL7

Health Level 7 international (HL7) has released an updated version of the controlled vocabulary for the "next-generation" electronic submission standard RPS (Regulated...[mehr]