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 The result is that previously communicated milestones are no longer applicable – the publication of the EU Implementation Guides (EU IGs) will not take place in 2018 and industry will not be requested to start submitting the product data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
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
…is a frequently asked question in the regulatory industry. The legislative EU deadline, 1st of July 2016, has kicked in a few days ago. EMA has given us some more time to prepare via an iterative approach and we need to prepare data to be ready within 2017 at latest. Read More
Current State of IDMP and the phased approach plan
On 25th of September the IRISS EU IDMP Task Force confirmed a phased IDMP implementation approach, while the official legislative date remains 1. July 2016. The European Commission has accepted the phased implementation approach as proposed to HMA in July as follows: Read More
We all know the legislative deadline for submitting pharmacovigilance data as IDMP (Identification of Medicinal Products), is July 1st of 2016. We only have just a bit over a year time to become IDMP ready and prepare for the submission of medicinal product information. Read More