Rebuttal: eCTD 4.0: More, Sooner!

The article discusses the complexities of targeted medicines and the recent discussion in the industry surrounding eCTD 4.0. It argues that the problem with eCTD 4.0 is not its complexity or cost, but rather the lack of clear benefits over the previous version. Some potential benefits of eCTD 4.0 are listed, including easier referencing of documents and the ability to update metadata. Implementing eCTD 4.0 has implications for software vendors as it requires them to update their systems to parse a different XML structure. However, eCTD 4.0 aims to allow changes to be made without a software update by entering new metadata for the changed items, which can lower the cost of maintaining software systems.