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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....[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]

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...[more]

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...[more]

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...[more]

Updated information for RPS R2 DSTU released by HL7

Health Level 7 international (HL7) has released updated information regarding the development of the Regulated Product Submissions (RPS) standard. The information concerns the...[more]

AU: Revised CTD Module 1 for Australia released by TGA

The Australian Therapeutic Goods Administration (TGA) has released a revised CTD Module 1. This new version incorporates the requirements of the streamlined submission process and...[more]