• M4E(R1): Efficacy

    Finalised Guideline: September 2002

    M4E(R1)

    Module 2 : Clinical Overview and Clinical Summary 

    Module 5 : Clinical Study Reports

    The clinical section of the Application.

    Re-edited with Numbering and Section Headers changes, September 2002

    CTD-Efficacy (M4E) describes the structure and format of the clinical data in an application, including summaries and detailed study reports. There are two high level clinical summaries in Module 2 of the CTD : the Clinical Overview, a short document that provides a critical assessment of the clinical data; and the Clinical Summary, a longer document that focuses on data summarisation and integration. Clinical Study Reports and raw data (where applicable) are included in Module 5 of the CTD.

    Implementation:

    Step 5

    EU:

    Adopted by CPMP, March 2003, issued as CPMP/ICH/2887/99 rev.1 Safety

    MHLW:

    Adopted on July 1, 2003, PFSB/ELD Notification No. 0701004

    FDA:

    To be notified

    M4E Q&As Document (R1)

    Finalised Q&As:
    June 2004

    The M4 Efficacy Questions & Answers (R4)
    Implementation:

    Step 5

    EU:

    Released for information as CHMP/ICH/5551/02, June 2004.

    MHLW:

    Adopted 24 November 2004, PFSB/ELD Notification

    FDA:

    Posted on the FDA website, September 12, 2006
    Clarification for Q&A 10 on submitting integrated summaries of safety and effectiveness (ISS/ISE) in the eCTD format (esrs/eCTD page). http://www.fda.gov/cder/regulatory/ersr/ISS_ISE_clarification.htm