Monats Archiv: März 2012

eCTD Module 5

eCTD Module 5

Module 5 Clinical Study Reports

The name of the folder for module 5 should be m5.

In cases where the application includes multiple therapeutic indications, the reports should be organized in a separate Section m535 for each indication. In such cases, if a clinical efficacy study is relevant to only one of the indications included in the application, it should be included in the appropriate section in m5 (eg m5\53-clin-stud-rep\535-rep-effic-safety-stud\anxiety\5351-stud-rep-contr). If a clinical efficacy study is relevant to multiple indications, the study report should be included in the most appropriate subsection of m535 and referenced as necessary in the equivalent section under the different indication.

In Module 2, a separate “Summary of Clinical Efficacy” module should be submitted for each indication, although closely related indications can be within a single document.
2012-03-22Permalink

eCTD Module 3

eCTD Module 3

Module 3 Quality

The name of the folder for module 3 should be m3.

Module 32S drug substance
If the product contains multiple drug substances, then documentation for each substance should be provided in its own m32s section. If a drug substance is manufactured at multiple sites or by multiple different manufacturing companies, documentation can be provided in multiple m32s sections.
 
Module 32p drug product

Each dosage form covered by an eCTD application should be described in its own m32p section. If an application describes multiple strengths of any one dosage form, then documentation that covers all strengths can be provided in a single m32p section, or alternatively each strength can be covered by its own strength-specific documents in multiple strength-specific CTD sections.

2012-03-22Permalink