Dublin, June 27, 2024 (GLOBE NEWSWIRE) -- The "eCTD Submissions - Fundamentals and Process" training has been added to ResearchAndMarkets.com's offering. eCTD Submissions, or electronic Common ...

药品国际化的星辰大海中，eCTD申报标准提供了一个通用技术框架，无缝整合了研发、生产、注册和监管等环节，是执行药品国际化的必要条件。中国药品监督管理局在2021年9月30日发布了《国家药监局关于实施药品电子通用技术文档申报的公告（2021年第119号》的 ...

*题图来自网络，仅作示意用。 世界卫生组织（WHO）于5月份更新了“WHO eCTD 门户和指南”页面，并宣告其药品预认证（Prequalification，PQT）将全面引入eCTD提交机制。 WHO实施时间表：2025自愿，2026强制，2027全面转换 WHO为eCTD的全面实施制定了详细的过渡时间表。

DUBLIN, Aug. 29, 2019 /PRNewswire/ -- The "eCTD Submissions of IND and NDA/BLA to the US FDA, EU and Canada" conference has been added to ResearchAndMarkets.com's offering. This two day workshop will ...

With an approaching deadline of 1 January 2019, Health Canada is requesting industry input on establishing mandatory requirements for submitting drug master files (DMFs) using the electronic common ...

DUBLIN--(BUSINESS WIRE)--The "eCTD Submissions of IND and NDA/BLA to the US FDA, EU and Canada" conference has been added to ResearchAndMarkets.com's offering. The international agreement to assemble ...

Joshua Boutwell, President and CEO of Aquila Solutions said, “We are pleased that our expertise in eCTD authoring is now available to everyone. We know our eCTD Templates will help sponsors save time ...

DUBLIN--(BUSINESS WIRE)--The "eCTD Submissions of IND and NDA/BLA to the US FDA, EU and Canada" webinar has been added to ResearchAndMarkets.com's offering. This four day webinar series (each day 3 ...

Drug approval is the goal of the long process of drug development. Once preclinical and clinical trial data have been collected, a New Drug Application must be submitted to the regulatory authority ...

In 2005, the heads of the European medicines agencies agreed that all EU member states must have the infrastructure and processes in place to handle only electronic Common Technical Document (eCTD) ...