News Archiv

Updated information regarding RPS R2 DSTU and RPS R3 available from HL7

Health Level 7 international has released new information regarding the development of the Regulated Product Submissions (RPS) standard.

The new information includes:

A new...[more]

New list of controlled vocabulary for RPS R2 DSTU available

A new list of controlled vocabulary for the Regulated Product Submission Release 2 - Draft Standard for Trial Use (RPS R2 DSTU) has been published on the RPS website of the HL7...[more]

Global: ICH releases version 3 of valid-values.xml for Study Tagging Files

The International Conference on Harmonization (ICH) Expert Working M2 has released a new version 3.0 of the "valid-values.xml". The valid-values.xml file is part of the...[more]

Updated eCTD NMV Business Requirements, new presentation on RPS Document Lifecycle

Updates regarding Regulated Product Submissions (RPS) and eCTD Next Major Version (NMV) have been released on the HL7wiki website (see link below).

The recent updates include

A...[more]

US: Further updates of RPS R2 DSTU documentation

Further updates regarding RPS (Regulated Product Submission) Release 2 DSTU have been released on the HL7wiki website. The new documents / information comprise

Final...[more]

Update - US: Complaints from FDA about misuse of the ESG Web Trader Interface

Update from 10-June-2010

Meanwhile, the FDA has released a statement on that issue on their ESG website (see also link below).

[Source: FDA...[more]

US: Updated documents and example code for RPS R2 DSTU released

The definition of the RPS (Regulated Product Submission) Release 2 DSTU (Draft Standard for Trial Use) is making further progress. In several recent updates,...[more]