common technical document (CTD)

The Common Technical Document (CTD) is a standardized format used by pharmaceutical companies to submit safety, quality, and efficacy data to regulatory authorities, such as the FDA or EMA. It organizes complex scientific information into five sections: administrative data, summaries, quality details, nonclinical study results, and clinical trial data. This structured format streamlines review processes, ensuring consistency and clarity across submissions from different companies and countries. Overall, the CTD helps regulators efficiently assess a drug’s safety and effectiveness before approval.