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Within the context of the ICH M2 Expert Working Group, discussions have been held the last couple of years on how to progress with the development of electronic messages supporting regulatory business between the pharmaceutical industry and regulatory agencies. ICH has chosen the direction of developing those standards within Standard Development Organisations (SDOs). The development of the new standard for the Individual Case Safety Reporting (ICSR) is the first example of this new ICH approach. The second example will be the eCTD Next major Version (eCTD NMV) for which a route via HL7 has been chosen. The eCTD NMV will build upon the experience gained in the first two versions of the Regulated Product Submission (RPS) standard.
Experience with the ICSR development in HL7 showed that an organised approach, particularly for a multi-state region as the EU, is a must in order to have the necessary regional input in this new and rather complex process. In order to facilitate this, a subgroup of the TIGes was set up at the beginning of 2009: the eCTD NMV/RPS Subgroup. The eCTD NMV/RPS subgroup is composed of representatives of FR, NL, DE, AT, UK, IRL, GR, EMA, EFPIA, EGA, EuropaBio and AESGP. The remit and main objectives of this group are:
- to set up the structure for work
- to organise EU input as a first step in the eCTD NMV requirements-gathering
- to learn the process and procedures within the SDO-environment (with HL7, ISO)
- to provide for a forum to exchange information on eCTD NMV, RPS and HL7
- to set up any future educational material with regard to RPS and/or RPS/eCTD NMV implementation
The group has met five times in 2009 and will continue the work in 2010, as from January 2010 the development of the RPS version 3 will begin in earnest. Additional documentation will be published as appropriate.
Documentation
- Meeting minutes, The Hague, The Netherlands, March 2009
- Meeting minutes, London, UK, April 2009
- Meeting Minutes, Vienna, Austria, July 2009
- Meeting minutes, Bonn, Germany, October 2009
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