U.S. Department of Health and Human Services
Food and Drug Administration
Center for Drug Evaluation and Research (CDER)
Center for Biologics Evaluation and Research
March 2005
ICH
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Guidance for Industry
M2: eCTD Specification
Questions and Answers and Change
Requests
This
guidance represents the Food and Drug Administration's (FDA's)
current thinking on this topic. It does not create or confer
any rights for or on any person and does not operate to bind FDA
or the public. You can use an alternative approach if the
approach satisfies the requirements of the applicable statutes
and regulations. If you want to discuss an alternative approach,
contact the FDA staff responsible for implementing this
guidance. If you cannot identify the appropriate FDA staff,
call the appropriate number listed on the title page of this
guidance.
This document provides guidance to
applicants on how to use the electronic Common Technical Document
(eCTD) specification. The guidance also answers questions that
have been raised about the eCTD specifications and provides a
change request table that tracks the status of all change requests
that have been received by ICH since the eCTD specification was
issued. The information provided here reflects the consensus of
the ICH parties. The questions and answers (Q&As) and the change
request table have been developed as a stand alone document that
is available with this guidance. The document will be updated
when the eCTD specification undergoes change control or new
questions are submitted to the ICH.
FDA's guidance documents, including this
guidance, do not establish legally enforceable responsibilities.
Instead, guidances describe the Agency's current thinking on a
topic and should be viewed only as recommendations, unless
specific regulatory or statutory requirements are cited. The use
of the word should in Agency guidances means that something
is suggested or recommended, but not required.
The ICH guidance M2: eCTD: Electronic
Common Technical Document Specification
was endorsed by the ICH in September 2002 and issued by the FDA in
April 2003. The eCTD specification
is intended to assist industry in the electronic transfer of their
marketing applications for human drug and biological products to a
regulatory authority. The guidance defines the means for
industry-to-agency transfer of regulatory information that will
facilitate the creation, review, life cycle management, and
archiving of the electronic submission.
The ICH has received a number of questions
with regard to the eCTD specification. In addition, some of the
questions posed to the ICH address change requests to the eCTD
specification. Questions and answeres
to the questions (Q&As) and change requests are maintained by the
ICH eCTD Implementation Working Group (IWG).
A change request tracking table has been
created to allow the public to monitor the status of all change
requests. This table reflects all change requests that have been
presented to the eCTD IWG and shows the status of the requests
as: (1) out of scope, (2) approved for the next change to the
eCTD specification, (3) approved but not requiring eCTD
specification changes; therefore can be put in the Q&As, (4)
deferred until a later date, (5) assigned for testing by the eCTD
IWG, or (6) rejected.
_______________
The
ICH updates the Q&As and change request tracking table
periodically. The most recent versions of the Q&As and table are
provided in a separate companion document available on the
Internet with this guidance.
This guidance was developed within
the M2 eCTD Implementation Working Group of the International
Conference on Harmonisation of Technical Requirements for
Registration of Pharmaceuticals for Human Use (ICH) and has been
subject to consultation by the regulatory parties, in accordance
with the ICH process. This document has been endorsed by the
ICH Steering Committee at Step 4 of the ICH process,
November 11, 2003. At Step 4 of the process, the final
draft is recommended for adoption to the regulatory bodies of
the European Union, Japan, and the United States.
