
[Federal Register Volume 80, Number 188 (Tuesday, September 29, 2015)]
[Notices]
[Pages 58492-58493]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-24623]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-D-3327]


E6(R2) Good Clinical Practice; International Conference on 
Harmonisation; Draft Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of a draft guidance entitled ``E6(R2) Good Clinical 
Practice.'' The draft guidance was prepared under the auspices of the 
International Conference on Harmonisation of Technical Requirements for 
Registration of Pharmaceuticals for Human Use (ICH). The draft guidance 
amends the guidance entitled ``E6 Good Clinical Practice: Consolidated 
Guidance'' (E6(R1)) to encourage implementation of improved and more 
efficient approaches to clinical trial design, conduct, oversight, 
recording, and reporting, and also updates standards regarding 
electronic records and essential documents. The draft guidance is 
intended to improve clinical trial quality and efficiency while 
maintaining human subject protection. FDA is making this draft guidance 
available for comment on the sections that are additions to ICH E6(R1) 
and marked as ``ADDENDUM.''

DATES: Although you can comment on any guidance at any time (see 21 CFR 
10.115(g)(5)), to ensure that the Agency considers your comment on the 
sections of this draft guidance marked as

[[Page 58493]]

``ADDENDUM'' before it begins work on the final version of the 
guidance, submit either electronic or written comments on the 
``ADDENDUM'' sections of the draft guidance by November 30, 2015.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Division of Drug Information (HFD-240), Center for Drug 
Evaluation and Research (CDER), Food and Drug Administration, 10001 New 
Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD 
20993-0002, or the Office of Communication, Outreach, and Development, 
Center for Biologics Evaluation and Research (CBER), Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver 
Spring, MD 20993-0002. Send one self-addressed adhesive label to assist 
the office in processing your requests. The draft guidance may also be 
obtained by mail by calling CBER at 1-800-835-4709 or 240-402-7800. See 
the SUPPLEMENTARY INFORMATION section for electronic access to the 
draft guidance document.
    Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Regarding the guidance: Dianne 
Paraoan, Center for Drug Evaluation and Research, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 3326, Silver 
Spring, MD 20993-0002, 301-796-2500; or Stephen Ripley, Center for 
Biologics Evaluation and Research, Food and Drug Administration, 10903 
New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 
240-402-7911.
    Regarding the ICH: Michelle Limoli, Center for Drug Evaluation and 
Research, International Programs, Food and Drug Administration, 10903 
New Hampshire Ave., Bldg. 71, rm. 7208, Silver Spring, MD 20993-0002, 
301-796-8377.

SUPPLEMENTARY INFORMATION:

I. Background

    In recent years, many important initiatives have been undertaken by 
regulatory authorities and industry associations to promote 
international harmonization of regulatory requirements. FDA has 
participated in many meetings designed to enhance harmonization and is 
committed to seeking scientifically based harmonized technical 
procedures for pharmaceutical development. One of the goals of 
harmonization is to identify and then reduce differences in technical 
requirements for drug development among regulatory agencies.
    ICH was organized to provide an opportunity for tripartite 
harmonization initiatives to be developed with input from both 
regulatory and industry representatives. FDA also seeks input from 
consumer representatives and others. ICH is concerned with 
harmonization of technical requirements for the registration of 
pharmaceutical products among three regions: The European Union, Japan, 
and North America. The eight ICH sponsors are the European Commission; 
the European Federation of Pharmaceutical Industries Associations; the 
Japanese Ministry of Health, Labour, and Welfare; the Japanese 
Pharmaceutical Manufacturers Association; CDER and CBER, FDA; the 
Pharmaceutical Research and Manufacturers of America; Health Canada; 
and Swissmedic. The ICH Secretariat, which coordinates the preparation 
of documentation, is provided by the International Federation of 
Pharmaceutical Manufacturers Associations (IFPMA).
    The ICH Steering Committee includes representatives from each of 
the ICH sponsors and the IFPMA, as well as observers from the World 
Health Organization.
    In June 2015, the ICH Steering Committee agreed that a draft 
guidance entitled ``Good Clinical Practice E6(R2)'' should be made 
available for public comment. The draft guidance is the product of the 
ICH E6 Expert Working Group of the ICH. Comments about this draft will 
be considered by FDA and the ICH E6 Expert Working Group.
    The draft guidance provides guidance on approaches to clinical 
trial design, conduct, oversight, recording, and reporting as well as 
updated standards regarding electronic records and essential documents. 
The additions to ICH E6(R1) are intended to encourage implementation of 
the described approaches and processes to improve clinical trial 
quality and efficiency while maintaining human subject protection. 
Evolutions in technology and risk management processes offer new 
opportunities to increase clinical trial efficiency, in part by 
focusing on trial activities essential to ensuring human subject 
protection and the reliability of trial results. For example, the draft 
guidance recommends sponsors implement a system to manage quality 
throughout clinical trials and recommends sponsors develop a 
systematic, prioritized, risk-based approach to monitoring clinical 
trials. The draft guidance provides additional detail regarding 
recommendations for use of electronic trial data handling and remote 
electronic trial data systems.
    This draft guidance includes additions to ICH E6(R1) that are 
identified as ``ADDENDUM'' and are marked with vertical lines on both 
sides of the text. FDA is making the draft guidance available for 
comment on the ``ADDENDUM'' text added to ICH E6(R1).
    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent the current thinking of FDA on E6(R2) Good 
Clinical Practice. It does not establish any rights for any person and 
is not binding on FDA or the public. You can use an alternative 
approach if it satisfies the requirements of the applicable statutes 
and regulations.

II. Comments

    Interested persons may submit either electronic comments regarding 
this document to http://www.regulations.gov or written comments to the 
Division of Dockets Management (see ADDRESSES). It is only necessary to 
send one set of comments. Identify comments with the docket number 
found in brackets in the heading of this document. Received comments 
may be seen in the Division of Dockets Management between 9 a.m. and 4 
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

III. Electronic Access

    Persons with access to the Internet may obtain the document at 
http://www.regulations.gov, http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, or 
http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm.

    Dated: September 23, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-24623 Filed 9-28-15; 8:45 am]
 BILLING CODE 4164-01-P


