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]

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]

Global: HL7 publishes a scope prioritization for RPS R3 scope topics

A scope prioritization for RPS R3 scope topics taking into account the ICH RPS requirements has been published by Health Level 7 (HL7) and is available from the HL7 wiki.[more]

Global: ICH releases business requirements for eCTD Next Major Version (NMV)

ICH M2 has initiated the development of the Next Major Version of the eCTD (eCTD NMV) to improve robustness, flexibility and long term stability of the message.

In accordance...[more]

Global: ESTRI releases a new version 1.18 of the Q&A to eCTD specification 3.2.2

A new version 1.18 of the eCTD specification 3.2.2 Q&A spreadsheet including the change requests has been released by ESTRI.

Five new Q&As (65-70) further...[more]

JP: PDMA releases example Module 1 regional-index.xml

The PDMA recently released an example jp-regional-index.xml for Japan alongside with a corresponding notification. The xml as well as the notification are currently available...[more]