The adoption of Regulation (EU) 2017/745 on Medical Devices (MDR) and Regulation (EU) 2017/746 on In-Vitro Diagnostic Devices (IVDR) changes the way medical devices will be regulated going forward. Read More
While the EMA is currently busy moving to the Netherlands and while the IDMP project currently seems to go slow, there is definite and significant progress being made in the background. The latest achievement is a major overhaul of the ISO/TS 19844 “Implementation guidelines for ISO 11238 for data elements and structures for the unique identification and exchange of regulated information on substances”. Read More
The implementation process of SPOR over several phases… that’s nothing new. However, after the 6-month delay due to the Brexit and the EMA relocation, there are some new actions planned for later this year. In the following we share the news from the last EMA webinar a few days ago: Read More
EMA will invite industry stakeholders to begin registering their super users and start using the RMS and OMS from October 2017.
Until the registration begins (October) industry stakeholders can view and search public data as guest users. In case of RMS, guest users can view public lists and for OMS, all content can be viewed. The OMS dictionary (list of organizations with associated physical locations) currently only includes NCA organization data and the dictionary will gradually be expanded with new data. Read More
On the 20th of June 2017, EMA provided new information to the Industry Change Liaisons as a part of their information cascade.
EMA has formally approved the P&SMS Iteration 1 project covering IDMP compatible authorized Human and Veterinary Products and Substances Management Services and it is underway. Read More
News and updates from the SPOR Task Force Meeting held on 10 March 2017. As previously communicated, OMS and RMS UAT has been kicked off this week and is still expected to go live for the end of May 2017 and the PMS and SMS go-live is still targeted for mid-2019. The good news is this: new efforts are now in place to build out timelines related to the various approval/project steps and the development and finalization of the EU guidance. The intended benefit of this more formalized project management approach is to ensure that the guidances are developed in a way that meets the requirements in terms of technical components and support for overall processes.
On August 4, 2016, The European Medicines Agency (EMA) hosted a webinar for the industry to further the understanding of the substance, product, organization and referential (SPOR) data services and related impacts. The European Commission, the European Union (EU) Network Data Board and the EU ISO IDMP Task Force have endorsed a phased implementation of the ISO IDMP standards. This approach will allow lessons learned during each phase to be applied to subsequent phases, processes and systems to mature over time and stakeholders to gain an understanding prior to the full roll out. Read More