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eCTD Update - October 2015

By  Lindsay Fitzgerald Lindsay Fitzgerald  on 2015-10-26 12:50:06  |  Featured in  Life Sciences , Regulatory Affairs , Regulatory Update
Lindsay Fitzgerald
Posted By Lindsay Fitzgerald
in Life Sciences in Regulatory Affairs in Regulatory Update
on 2015-10-26 12:50:06

DataThe Electronic Common Technical Document (eCTD) world is a fast-paced, consistently changing environment.  More health authorities around the world are accepting and/or requiring eCTD submissions and the agencies already accepting eCTD submissions are refining their guidance to keep up with changes in technology.  At Paragon, we are here to help you keep up-to-date with eCTD activities around the world.  Here are some recent highlights and events.

The Thailand Bureau of Drug Control will begin accepting eCTD submissions in 2016.  The TH eCTD Specification highlights Module 1 requirements modeled after the European and Canadian guidelines.  Modules 2 through 5 are drafted from the International Conference on Harmonization (ICH) guidelines.  However, the DTD has not yet been released.  Depending on its release date, the timeline for requiring eCTD submissions, which is currently slated for 2017, may be delayed. 

The US FDA has released an eCTD Technical Conformance Guide.  Among other things, the document includes a section highlighting the Agency’s recommendation for submitting study data using the eCTD format.  It also includes sections on Study Data Submission Format for Clinical and Nonclinical and data validation and traceability.  For more information on Study Data Standards, please visit the FDA.

The US FDA has also issued a note to docket for the Risk Evaluation and Mitigation Strategies (REMS) Structured Product Labeling (SPL) pilot.  The Agency is looking for organizations that wish to take part in the pilot that will run for 4 months beginning on October 6, 2015 and ending February 3, 2016 with an extension option as resources or needs permit.  A formal presentation was delivered at the REMS Public Meeting October 5 – 6, 2015 and is posted here.  For more information and instructions for how your organization can participate in the pilot please visit the Federal Register website here

Health Canada has announced that it will now accept Drug Master Files (DMFs) in “non-eCTD electronic-only” format and has issued a guidance document.  Effective October 5, 2015, new DMFs, translations relating to existing DMFs and DMF updates (the first of which much include a complete conversion for the existing DMF in paper format) should be provided in “non-eCTD electronic only” format. 

As of January 1, 2016, Health Canada will no longer accept paper DMFs and as of March 31, 2016, all existing paper DMFs must be replaced with a “non-eCTD electronic only” conversion.  For more information please visit Health Canada.

The European Doctorate for the Quality of Medicines and Healthcare (EDQM) has released The Electronic Submissions for CEP Applications Draft Roadmap 2016 – 2020 for comment.  Due to significant changes in the current process, the EDQM would like to gather comments for review prior to implementation.  The deadline for submitting comments is December 31, 2015. 

Paragon Solutions has extensive experience in eCTD submissions and can help your organization prepare for submitting to new markets or help implement the newest solution to meet the ongoing changes in technology.  Some of the services Paragon provides are:

  • Process Development, Best Practices, and Training
  • Template Review, Development, and Use
  • Vendor Tool Selection Process, Software Implementation, Validation, and Migration
  • Regulatory Intelligence including Guidance Interpretation, Implementation, and Training
  • eCTD Compliance Assessments and Global Dossier Planning
  • eSubmission Preparation – Requirement Analysis and Training

 

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Lindsay Fitzgerald

Lindsay Fitzgerald

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Lindsay Fitzgerald is an IT Business Analyst and Principal Consultant with Paragon’s Life Sciences team, focusing on project management and support of users in the Regulatory Affairs department. She has worked with large, global pharmaceutical companies and has experience working in a global environment on multiple projects, systems and tools simultaneously. Lindsay has a deep understanding of end-user requirements in a highly regulated environment, and ensures those requirements are met when the technical solutions are delivered. She has a Bachelor of Science in Management of Information Technology from Peirce College of Philadelphia.

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