Category Archives: Industry-specific Topics

This category informs about topics that are relevant for the whole industry

Electronic submissions in the EAEU – publishing module available for interested LORENZ customers

LORENZ has implemented a publishing module for EAEU submissions in docuBridge based on the EECB No. 79 specifications and the R.022 schema. Interested customers can connect to LORENZ Cloud for an early glimpse on how to publish EAEU submissions. Please contact your Account Manager for further information. The publishing module will be continually updated to reflect any further specification changes. The EAEU submission publishing will soon be commercially available as a normal docuBridge publishing module. Continue reading

eCTD submissions in China: CDE is now soliciting opinions on eCTD submission guidelines

On September 17, 2019, the official website of the CDE of the Chinese NMPA began soliciting public opinions on the preliminary draft of eCTD submission guidelines, the supporting eCTD technical specifications, verification standards and other related documents.  The deadline for submitting opinions is October 17, 2019. Please provide your feedback before this closing date.

Previously, the draft eCTD specifications and validation criteria had been issued for advice in March 2019. This second round of public consultation signals that China is now in the final stage of eCTD preparation, and that the eCTD pilot phase will soon be launched.  This means that companies should be fully prepared to implement eCTD submissions, and possibly willing to participate in the pilot.

For the original notification from CDE, please click here.

Updates on the HMA eSubmission Roadmap

The eSubmission Roadmap v2.2 has recently been updated by the HMA. The purpose of the roadmap is to provide a high level strategic plan for business and technology changes over several years, and is meant to help NCAs, EMA and pharmaceutical industry prepare themselves for the forthcoming changes. Many of the adjustments are likely due to the EMA’s relocation.

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eCTD submissions in China – next step has been taken

In November 2018, we released a press release regarding the Chinese NMPA, noting that the agency selected our docuBridge and eValidator solution as an eCTD data management system. Now, the next step has been taken towards introducing eCTD submissions in China.

The CDE of the NMPA published the Chinese eCTD specification on March 1, 2019. Comments are appreciated until April 1, 2019. This marks an important milestone in China´s eCTD project, beginning the countdown to the final implementation of eCTD submissions in China.

Because of our involvement in this project, we can offer our customers around the world a head start in meeting China´s new eCTD submissions requirements. Please feel free to contact us or ERIS, our distributor for LORENZ e-regulatory affairs solutions in mainland China, regarding inquiries and further collaboration.

LORENZ docuBridge, eValidator and Automator implementation progressing at US FDA – Preparing to migrate 1.3 million eCTD sequences

In response to questions about our ongoing implementation project at the US FDA, we would like to share a short update with you.

In our previous blogpost, we announced the need to migrate approximately 1.3 million legacy eCTD sequences into our docuBridge solution and make them available to US FDA reviewers.

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International Trends in Drug Registration and Evaluation [Part 3: ISO IDMP and the MPID]

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.

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