While the opinions about the information model for Regulatory Information Management vary and are subject to many discussions, the one thing most agree on is that promise of regulatory information management (RIM) is that of enabling both compliance and efficiency. 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
The FDA deadline on NDA, ANDA, BLA and DMF (paper submissions) is less than 4 weeks away. By 5th of May 2017 the FDA requires that all DMFs are to be submitted in the eCTD format via the Electronic Submissions Gateway (ESG). If your DMF is in paper format with FDA, the same submission does not need to be resubmitted in eCTD format. However, as you move forward it is important to make sure your documents are properly prepared (bookmarked, OCR’d, proper orientation) and you can create your baseline DMF submission as eCTD. The DMF in eCTD format mandate applies to amendments, letters of authorization and annual reports. 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.