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
Yesterday US FDA has published a new guidance “M4 Organization of the Common Technical Document for the Registration of Pharmaceuticals for Human Use – Guidance for Industry”. FDA has addressed recommendations for eCTD 4.0. The guidance also provides separate tables describing the recommended granularity for paper and eCTD v3.2.2 submissions, and for paper and eCTD v4 submissions.
On June 21, 2017, FDA communicated their intent to ensure that patients are not being priced out of the medicines they need by taking steps to facilitate increased competition in the market for prescription drugs through the approval of lower-cost, generic medicines. 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.
As one of the last actions in 2016 (effective December 17, 2016) the FDA enforced some new criteria that will allow them to reject an eCTD submission if there is non-compliance with key study data requirements.
FDA notes in their guidance “The standards apply to the following types of submissions to CDER and CBER:
In September 2016, the FDA published new deadlines on electronic submissions:
May 5, 2017: NDA, BLA, ANDA and DMFs must be in eCTD format
May 5, 2018: Commercial INDs must be in eCTD format
Since January 1st 2016, all Submission new DMF submissions to Health Canada have to be submitted in an electronic format called “non eCTD electronic-only”. In addition to the January 1st deadline, all existing DMF’s have to be replaced by an electronic version by March 31st 2016. 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
As a regulatory affairs professional, being responsible for drug submissions is an exciting task, but it also comes with many dimensions of complexity and pressure. Recently a new technological trend, „cloud“ or „software as a service“, is creating more questions and the potential for confusion. Read More