NeeS: A Thing of the Past

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With 2018 well underway, if you’re still not submitting in electronic Common Technical Document (eCTD) format in Europe, now is the time to transition. Non-eCTD electronic Submission or “NeeS” have been accepted for many years. However, they are becoming less common for National Procedures. Furthermore, at the end of this year, NeeS will be a thing of the pastOn 10 March 2017, the European Heads of Medicines Agenices (HMA) announced that eCTD will be mandatory for all regulatory activities in National Procedures as of January 1, 2019.

NeeS technical guidance, which you may want to start considering “legacy,” and information on it can be found at the esubmission.ema.europa.eu website.  More importantly, eCTD submission information and the implementation roadmap in the EU (below) can be found there as well.

NeeS to eCTD eSubmission roadmap - timelines

NeeS is essentially a collection of files organized in a series of folders. eCTD, on the other hand, is a more powerful option, facilitating easy dossier and lifecycle maintenance and navigation via an xml backbone. Plan your switch now. Do not wait, regardless of if you intend to purchase your own publishing software or seek to outsource.  Process, technology and work flow adjustments are common bridging between NeeS and eCTD.

Need help implementing eCTD? Synchrogenix’s team of publishers brings over ten years’ experience in helping to convert clients from paper to electronic format.

We provide personal attention to our clients through dedicated publishing teams, yet are scalable to accommodate needs as necessary, without sacrificing quality or our transparent and consistent pricing integrity. Our software and AI-enabled technology allows us to perform actions at faster rates while achieving greater quality. Additionally, our regulatory and writing experts can provide other offerings as needed such as Regulatory Strategy, Affairs, and Authoring to ensure project success.

So if you’re not prepared for the eCTD mandate, contact us today at contactus@synchrogenix.com.

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Author: Rob Labriola

Rob Labriola has 20 plus years experience in regulatory operations for the pharmaceutical industry. Mr. Labriola has seen it all and truly understands the frustrations and rewards of moving to eCTD. He has worked on multiple application types (INDs, NDAs, BLAs, CTAs, NDSs, JNDAs and MAAs), and has extensive international experience, having submitted applications to the FDA, Canada, Europe, Switzerland, Australia, Israel, Japan, etc.

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