Streamlining Regulatory Documentation: Exploring the Common Technical Document (Ctd) and Electronic Submission, With Emphasis on M Series According to Ich Guidelines
RASHYAP SARASWAT,
ANKITA RAIKWAR,
SUBHRANSHU PANDA
Abstract:A number of regulatory bodies have worked together to create the Common Technical Document (CTD), including the United States Food and Drug Administration, the European Medicines Agency, and the Japanese Ministry of Health. This standardized format facilitates the collection and submission of regulatory documentation pertaining to applications for new medicines. Since its inception in 2000, the CTD has been widely adopted internationally, including by nations such as Canada, Australia, and India. The CTD aims … Show more
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