We would like to provide our customers and the industry with an update on the status of LORENZ’ implementation of LORENZ docuBridge, eValidator, and Automator at the U.S. Food and Drug Administration (FDA).
(Please click here to read our previous blogpost including a timeline of events from 1 July 2016 – 30 May 2017.)
Today Jared Lantzy, Manager Global Regulatory Agencies and Processes at LORENZ, starts with a series of articles talking about international trends in Drug Registration and Evaluation. He will provide an update on some selected topics in electronic submissions and some insight into how LORENZ will deal with these evolving regulatory requirements.
Regulatory authorities around the world continue to adopt internationally recognized data standards in an effort to improve the efficiency of their work environments and processes. The most commonly discussed data standards are the Electronic Common Technical Document (eCTD); International Organization for Standardization (ISO) Identification of Medicinal Products (IDMP); Health Level 7 (HL7) Structured Product Labeling (SPL)-based standards for the transmission of product data, including IDMP; and Clinical Data Interchange Standards Consortium (CDISC)-based standards for both clinical and non-clinical study data.
We at LORENZ have been receiving an increasing number of emails and phone calls from our customers and partners concerning the current state of the project implementing LORENZ docuBridge, eValidator, and Automator at the U.S. Food and Drug Administration (FDA).
In order to clarify the chain of events and alleviate any concerns, we are outlining below a timeline of events we hope will be helpful.
The presentation “Which comes first: Regulatory Information Management (RIM) or ISO Identification of Medicinal Products (IDMP)?” was given by Deborah Cooper, Vice President Consulting at GENPACT Pharmalink, at LORENZ userBridge.15 in Vienna, Austria.
In her presentation, Deborah Cooper discussed the impact of the ISO IDMP Implementation Roadmap on RIM strategies and presented the GENPACT IDMP readiness assessment for customers.
The ISO IDMP Standard and Iterative Implementation Roadmap
Based on EU Commission Implementing Regulation No 520/2012 (articles 25 and 26), the EMA is in the process of implementing the five ISO standards for IDMP (ISO 11238, 11239, 11240, 11615 and 11616). This should simplify the exchange of information between regulatory authorities, enhancing the interoperability of systems at EU level and internationally. 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.
One of the biggest changes to the electronic common technical document (eCTD) in the past few years was the introduction of the United States Food and Drug Administration’s (USFDA) newest module 1 specifications and corresponding technical files. The new specifications v2.3 and the XML Document Type Definition (DTD) v3.3 were developed to enhance USFDA’s ability to process eCTD submissions and enable additional submission types that were previously not accepted in eCTD format.
After a lengthy testing period, USFDA began accepting submissions using the new v2.3 specifications in June 2015 and has now received thousands of submissions using the new module 1. While uptake has been good, most submissions were applications being submitted to USFDA for the first time, starting from a clean slate with the new specifications.
Transitioning existing applications to the new module 1 adds complexity to eCTD publishing but should not be treated as roadblock. Here we will discuss preparing existing applications for the transition and ways to smooth the process for a successful transition.
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.
With the release of version 3.3 of its eCTD Module 1 specifications, the US FDA has enabled industry to streamline eSubmission processes. With these new features come added complexity that must be mastered to take full advantage of upgraded functionality. Join us at the inaugural LORENZlink RIM conference on April 4 – 5, 2016 in Scottsdale, AZ, for a detailed discussion of changes and lessons learned to ensure a successful transition to the new Module 1. You will learn about:
- FDA experience with the new Module 1 including common validation errors
- Considerations and best practices for transition
- When and why grouped submissions make sense
- Tips for preparing and submitting Promotional Labeling and Advertising in eCTD format
- Updates on US FDA’s upcoming eCTD mandate