close menu

Lorenz Blog

Selected category: "Regulatory Affairs News" clear
1 - 8 of 36

The China National Medical Products Administration (NMPA) have announced specific requirements regarding the implementation of electronic submissions of application materials for drug registration applications. With this, they plan to optimize the business environment, reduce the burden on enterprises, and improve the efficiency of drug review and approval.

This entry was posted in Regulatory Affairs News.

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.

1 - 8 of 36
© Copyright LORENZ Life Sciences Group. All rights reserved.