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Transformative changes related to submission management has become a popular discussion in many global forums over the past few years. This has primarily been fuelled on by the pandemic and the realization that modernization in regulatory practices and frameworks is vital to keep up with the needs of tomorrow.

Drug submissions continue to shift towards standardized formats and increase in volume, complexity. We have seen an evolution from uncontrolled paper to a broader global use of electronic Common Technical Document (eCTD) over the past years.

This entry was posted in LORENZ Events, Regulatory Affairs News.

Since the EMA has changed the ISO IDMP timeline in order to push the Digital Application Dataset Integration Project (DADI), we want to offer you an overview of what has changed and the reasons behind it.

This entry was posted in Regulatory Affairs News.

The Chinese National Medical Products Administration’s (NMPA) Center for Drug Evaluation (CDE) has finalized the launch timing for eCTD submissions in China, and released the relevant eCTD technical documents on September 30, 2021. These include:

  • eCTD Technical Specification V1.0
  • eCTD Validation Criteria V1.0
  • eCTD Implementation Guide V1.0
  • and the eCTD Technical Specification V1.0 attachment.

This entry was posted in Regional News, Regulatory Affairs News.

Dr. Franziska Menzel, the Head of Regulatory Affairs at our longstanding customer CO.DON AG and Matthias Schremser, Global Key Account Manager Industry and Agency at LORENZ, sat down together to talk about the experience of upgrading from LORENZ docuBridge ONE to FIVE.

This entry was posted in LORENZ News, Regulatory Affairs News.

Update on EU IDMP implementation

Posted on August 19, 2021

The year 2021 is a landmark one for IDMP implementation. After version 2.0 of the EU IDMP guide came out in February, version 2.1 of the implementation guide was released on 30 June. This now leaves only version 2.2 in the pipeline; currently anticipated in Q3 of 2021. After that, depending on the outcomes and learnings from step 1 of the TOM (Target Operating Model) implementation, version 3.0 of the EU IDMP guide will be published to support step 2.

Version 2.1 of the EU implementation guide now covers the following chapters and content:

This entry was posted in Regulatory Affairs News.

On March 10, 2021, the USFDA announced that they would begin to enforce the new eCTD validation checks on September 15, 2021. From then on, the USFDA could start rejecting submissions that do not conform with the Technical Rejection Criteria (TRC) formulated in the new eCTD validation criteria (v3.9) with error codes 1734, 1735, 1736, and 1789 for study data. In addition, the eCTD validation criteria for both CBER and CDER are starting to differ significantly from each other.

This entry was posted in Regulatory Affairs News.

On July 20, the CDE of China's NMPA released the guidelines for the submission of drug clinical trial data..

All chemical and biological products be governed by these new guidelines starting on October 1, 2020, as part of China's wider eCTD implementation following the release of M4 module 1 document.

This entry was posted in Regional News, Regulatory Affairs News.

The Center of Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA) has issued the “M4 Module 1: Administration documents and drug information”, which took effect on July 1, 2020.

This is the result of the activities the NMPA began in April 2020, when they started to solicit public comments on the draft version of several documents. For more details on this, have a look at our previous blog post.

This entry was posted in Regional News, Regulatory Affairs News.

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