EMA CTD Module Writing

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EMA CTD Module Writing

The Common Technical Document (CTD) describes the organisation of modules, sections and documents to be used by an Applicant for a Marketing Authorisation for a medicinal product for human use. The CTD is organised into five modules. Module 1 is region specific and Modules 2, 3, 4 and 5 are intended to be common for all regions. The CTD became the mandatory format for new drug applications in the EU.

Article 10a Well-Established use Application

MODULE 2: COMMON TECHNICAL DOCUMENT SUMMARIES

2.4 Non-clinical Overview

2.5 Clinical Overview

MODULE 4: NONCLINICAL STUDY REPORTS

Article 10a Generic Application

MODULE 2: COMMON TECHNICAL DOCUMENT SUMMARIES

2.4 Non-clinical Overview

2.5 Clinical Overview

2.6 Nonclinical Written and Tabulated Summaries

MODULE 4: NONCLINICAL STUDY REPORTS