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In the 1980s, the European Union began harmonising regulatory requirements. In 1989, Europe, Japan, and the United States began creating plans for harmonisation. The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) was created in April 1990 at a meeting in Brussels.
The CTD is maintained by the International Council on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). [1] [2] After the United States, European Union and Japan, the CTD was adopted by several other countries including Canada [3] and Switzerland. [1]
On May 5, 2015, the U.S. Food & Drug Administration published a final, binding guidance document [7] requiring certain submissions in electronic (eCTD) format within 24 months. The projected date for mandatory electronic submissions is May 5, 2017 for New Drug Applications (NDAs), Biologic License Applications (BLAs), Abbreviated New Drug ...
A source document is a document in which data collected for a clinical trial is first recorded. This data is usually later entered in the case report form.The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH-GCP) guidelines define source documents as "original documents, data, and records."
A champion rower has died while free-diving. According to a GoFundMe page, shared last week, 27-year-old Austin Regier died in the Philippines on November 14, 2024. "He was swimming with new ...
A woman who has sat in prison for more than a decade was released Tuesday after new evidence contradicted accounts that she helped a hitman take out an innocent victim 25 years ago in the Bronx.
Documentation requirements for the set-up and maintenance of quality systems, electronic systems, safety monitoring, and proof of an adequate and well-controlled trial, to name a few, exist in various regulations across many countries or regions, but are not explicitly described in ICH GCP E6.
The college football early signing period starts this week. Here's what you need to know about it, including dates and recruiting rankings: