Summary of part 1 and 2:
In our last blog posts of the series you were informed about eCTD v3.2.2 and eCTD v4.0. The articles resolved around the advantages of eCTD v3.2.2 over paper or non-eCTD electronic submissions and the improvements from eCTD v4.0 over eCTD v3.2.2. If you have not read it, you will find the first article here and the second article here.
Our last blog post on this topic covered eCTD v3.2.2 and its advantages over paper or non-eCTD electronic submissions. The main selling points of v3.2.2 are its reliable presentation of information to reviewers, the level of flexibility for national authorities, the metadata for automated processing, the life cycle information on documents, and the reuse of information.
In this second part of our series about international trends in drug registration we dive into the improvements from eCTD v4.0 over eCTD v3.2.2.
Markus Pfahlert, Product Manager of LORENZ drugTrack, participated in the ISO IDMP Task Force Meeting in February and compiled this summary of the outcomes.
Representatives from EMA, NCA, industry, consultants and vendors participated in this meeting.
Referentials & Organisations
(click here to view the whole presentations: Referentials, Organisations)
Currently the Referentials Group is trying to create a common exchange process for distributing referentials lists. There are 2 different activity streams for each: 1) the gathering (or mapping of already existing data such as EVMPD) and 2) the distribution. For the latter, help from vendors will be needed on both the exchange process itself and for a User Acceptance Test (UAT) on building the exchange system.
Markus Pfahlert, Product Manager of LORENZ drugTrack, participated in the ISO IDMP Task Force Meeting in September and compiled this summary of the outcome.
The European Commission agrees to the Phased Approach
The transition phase will consist of two parts; the Pre-Submission Phase and the Submission Phase itself. Directly following that, the Maintenance Phase will begin.
The Pre-Submission Phase is planned to begin in July 2016 and to continue through the beginning of 2017, with three primary goals:
Participating in the ISO IDMP Task Force and in consultation with a variety of other stakeholders, we have formed a proposal on how the ongoing EMA planning could be interpreted from an industry perspective.
The European Medicines Agency (EMA) and the EU Regulatory Network are pursuing an open dialogue with industry to discuss aspects of implementing the ISO IDMP standards in the EU. LORENZ is taking part in the ISO IDMP Task Force (TF) which has been established to advise on the planning, development, implementation and maintenance of the EU’s ISO IDMP standards. This Task Force met on Friday, 12 June. Based on that meeting and on other discussions with a variety of stakeholders, a proposal has been developed on how the EMA’s planning could be interpreted from an industry perspective. It should be noted that the official implementation date remains 1 July 2016. However, there is currently only one timing plan being worked on, and this foresees a phased approach to implementation. The picture above illustrates these proposed high level implementation timelines.
The presentation “Using the EMA Gateway & CESP for Electronic Submissions” was given by Beate Kienzler, Head of Regulatory Affairs at Dr. Regenold GmbH, at LORENZ userBridge.14 in Milan, Italy.
For some years now, electronic submission gateways and how to use them have been a hot topic of discussion in the Regulatory Affairs world. Following the move from paper to electronic submission formats, gateways can be considered the next step in an evolution. As Beate Kienzler put it during her presentation at the LORENZ userBridge.14 conference in Milan, “we are moving from low parcel content to no parcel content”. Continue reading