With an ever-increasing regulatory landscape, it is important to know what is coming next. Looking into regulatory world – we are aware of some changes that are coming along the way and we are certain that these will affect many of us. Therefore, it is crucial to be prepared for all the changes. We at Cunesoft believe in the importance of sharing knowledge and helping each other to prepare for upcoming regulations. Therefore we would like to share with you the summary of some important regulatory activities that are coming next year and beyond.
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
A combination of factors has resulted in the shifting timeline of EMA’s implementation of the IDMP data collection. One factor is the pending relocation of EMA due to Brexit. Additional factors include the experience gained from implementation of RMS and OMS projects and the delivery method of the P&SMS project to engage the stakeholders. The result is that previously communicated milestones are no longer applicable – the publication of the EU Implementation Guides (EU IGs) will not take place in 2018 and industry will not be requested to start submitting the product data in a new format in 2019. 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
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