83 FR 8279 - Q11 Development and Manufacture of Drug Substances-Questions and Answers (Chemical Entities and Biotechnological/Biological Entities); International Council for Harmonisation; Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 38 (February 26, 2018)

Page Range		8279-8280
FR Document		2018-03809

The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance entitled ``Q11 Development and Manufacture of Drug Substances--Questions and Answers (Chemical Entities and Biotechnological/Biological Entities).'' The guidance was prepared under the auspices of the International Council for Harmonisation (ICH), formerly the International Conference on Harmonisation. The guidance consists of questions and answers that were developed to clarify the principles for selecting starting materials described in the ICH guidance ``Q11 Development and Manufacture of Drug Substances'', published November 20, 2012. The guidance is intended to provide additional clarification and to promote convergence on the considerations for the selection and justification of starting materials. The questions and answers focus on chemical entity drug substances, and provide recommendations on the information that should be provided in marketing authorization applications and/or master files to justify the starting materials.

Federal Register, Volume 83 Issue 38 (Monday, February 26, 2018)

[Federal Register Volume 83, Number 38 (Monday, February 26, 2018)]
[Notices]
[Pages 8279-8280]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2018-03809]

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-D-0436]

Q11 Development and Manufacture of Drug Substances--Questions and
Answers (Chemical Entities and Biotechnological/Biological Entities);
International Council for Harmonisation; Guidance for Industry;
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a guidance entitled ``Q11 Development and
Manufacture of Drug Substances--Questions and Answers (Chemical
Entities and Biotechnological/Biological Entities).'' The guidance was
prepared under the auspices of the International Council for
Harmonisation (ICH), formerly the International Conference on
Harmonisation. The guidance consists of questions and answers that were
developed to clarify the principles for selecting starting materials
described in the ICH guidance ``Q11 Development and Manufacture of Drug
Substances'', published November 20, 2012. The guidance is intended to
provide additional clarification and to promote convergence on the
considerations for the selection and justification of starting
materials. The questions and answers focus on chemical entity drug
substances, and provide recommendations on the information that should
be provided in marketing authorization applications and/or master files
to justify the starting materials.

DATES: The announcement of the guidance is published in the Federal
Register on February 26, 2018.

ADDRESSES: You may submit either electronic or written comments on
Agency guidances at any time as follows:

Electronic Submissions

Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

Submit written/paper submissions as follows:
Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2011-D-0436 for ``Q11 Development and Manufacture of Drug
Substances--Questions and Answers (Chemical Entities and
Biotechnological/Biological Entities).'' Received comments will be
placed in the docket and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at https://www.regulations.gov or at
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through
Friday.
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.thefederalregister.org/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
Submit written requests for single copies of this guidance to the
Division of Drug Information, Center for Drug Evaluation and Research,
Food and Drug Administration, 10001 New Hampshire Ave., Hillandale
Building,

[[Page 8280]]

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 that office in processing
your requests. The guidance may also be obtained by mail by calling
CBER at 1-800-835-4709 or 240-402-8010. See the SUPPLEMENTARY
INFORMATION section for electronic access to the guidance document.

FOR FURTHER INFORMATION CONTACT:
Regarding the guidance: Stephen Miller, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 22, Rm. 1446, Silver Spring, MD 20993-0002, 301-796-1418, 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: Amanda Roache, Center for Drug Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, Rm. 1176, Silver Spring, MD 20993-0002, 301-796-4548.

SUPPLEMENTARY INFORMATION:

I. Background

In recent years, regulatory authorities and industry associations
from around the world have participated in many important initiatives
to promote international harmonization of regulatory requirements under
the ICH. FDA has participated in several ICH meetings designed to
enhance harmonization and FDA is committed to seeking scientifically
based harmonized technical procedures for pharmaceutical development.
One of the goals of harmonization is to identify and reduce differences
in technical requirements for drug development among regulatory
agencies.
ICH was established to provide an opportunity for 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
for human use among regulators around the world. The six founding
members of the ICH are the European Commission; the European Federation
of Pharmaceutical Industries Associations; the FDA; the Japanese
Ministry of Health, Labour, and Welfare; the Japanese Pharmaceutical
Manufacturers Association; and the Pharmaceutical Research and
Manufacturers of America. The Standing Members of the ICH Association
include Health Canada and Swissmedic. Any party eligible as a Member in
accordance with the ICH Articles of Association can apply for
membership in writing to the ICH Secretariat. The ICH Secretariat,
which coordinates the preparation of documentation, operates as an
international nonprofit organization and is funded by the Members of
the ICH Association.
The ICH Assembly is the overarching body of the Association and
includes representatives from each of the ICH members and observers.
The Assembly is responsible for the endorsement of draft guidelines and
adoption of final guidelines. FDA publishes ICH guidelines as FDA
guidances.
In the Federal Register of February 21, 2017 (82 FR 11225), FDA
published a notice announcing the availability of a draft guidance
entitled ``Q11 Development and Manufacture of Drug Substances--
Questions and Answers (Regarding the Selection and Justification of
Starting Materials).'' The notice gave interested persons an
opportunity to submit comments by March 23, 2017.
After consideration of the comments received and revisions to the
guideline, a final draft of the guideline was submitted to the ICH
Assembly and endorsed by the regulatory agencies in August 2017.
The guidance consists of questions and answers that were developed
to clarify the principles for selecting starting materials described in
the ICH guidance ``Q11 Development and Manufacture of Drug
Substances,'' published November 20, 2012 (77 FR 69634). The guidance
provides guidance on selecting and justifying starting materials, in
particular for the synthesis of chemical entity drug substances.
This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
current thinking of FDA on ``Q11 Development and Manufacture of Drug
Substances--Questions and Answers (Chemical Entities and
Biotechnological/Biological Entities).'' 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. This guidance is not subject to
Executive Order 12866.

II. Electronic Access

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

Dated: February 20, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-03809 Filed 2-23-18; 8:45 am]
BILLING CODE 4164-01-P

8280 Federal Register / Vol. 83, No. 38 / Monday, February 26, 2018 / Notices

4th Floor, Silver Spring, MD 20993– Ministry of Health, Labour, and Welfare; II. Electronic Access
0002, or the Office of Communication, the Japanese Pharmaceutical Persons with access to the internet
Outreach and Development, Center for Manufacturers Association; and the may obtain the document at https://
Biologics Evaluation and Research Pharmaceutical Research and www.regulations.gov, https://
(CBER), Food and Drug Administration, Manufacturers of America. The www.fda.gov/Drugs/
10903 New Hampshire Ave., Bldg. 71, Standing Members of the ICH GuidanceCompliance
Rm. 3128, Silver Spring, MD 20993– Association include Health Canada and RegulatoryInformation/Guidances/
0002. Send one self-addressed adhesive Swissmedic. Any party eligible as a default.htm, or https://www.fda.gov/
label to assist that office in processing Member in accordance with the ICH BiologicsBloodVaccines/
your requests. The guidance may also be Articles of Association can apply for GuidanceCompliance
obtained by mail by calling CBER at 1– membership in writing to the ICH RegulatoryInformation/Guidances/
800–835–4709 or 240–402–8010. See Secretariat. The ICH Secretariat, which default.htm.
the SUPPLEMENTARY INFORMATION section coordinates the preparation of
for electronic access to the guidance documentation, operates as an Dated: February 20, 2018.
document. international nonprofit organization and Leslie Kux,
is funded by the Members of the ICH Associate Commissioner for Policy.
FOR FURTHER INFORMATION CONTACT:
Regarding the guidance: Stephen Association. [FR Doc. 2018–03809 Filed 2–23–18; 8:45 am]
Miller, Center for Drug Evaluation and The ICH Assembly is the overarching BILLING CODE 4164–01–P

Research, Food and Drug body of the Association and includes
Administration, 10903 New Hampshire representatives from each of the ICH
Ave., Bldg. 22, Rm. 1446, Silver Spring, members and observers. The Assembly DEPARTMENT OF HEALTH AND
MD 20993–0002, 301–796–1418, or is responsible for the endorsement of HUMAN SERVICES
Stephen Ripley, Center for Biologics draft guidelines and adoption of final
guidelines. FDA publishes ICH Food and Drug Administration
Evaluation and Research, Food and
Drug Administration, 10903 New guidelines as FDA guidances. [Docket No. FDA–2018–N–0001]
Hampshire Ave., Bldg. 71, Rm. 7301, In the Federal Register of February
Silver Spring, MD 20993–0002, 240– 21, 2017 (82 FR 11225), FDA published Center for Drug Evaluation and
402–7911. a notice announcing the availability of Research and You: Keys to Effective
Regarding the ICH: Amanda Roache, a draft guidance entitled ‘‘Q11 Engagement; Public Workshop
Center for Drug Evaluation and Development and Manufacture of Drug
AGENCY: Food and Drug Administration,
Research, Food and Drug Substances—Questions and Answers
HHS.
Administration, 10903 New Hampshire (Regarding the Selection and
Justification of Starting Materials).’’ The ACTION: Notice of public workshop.
Ave., Bldg. 51, Rm. 1176, Silver Spring,
MD 20993–0002, 301–796–4548. notice gave interested persons an SUMMARY: The Food and Drug
SUPPLEMENTARY INFORMATION: opportunity to submit comments by Administration’s (FDA) Center for Drug
March 23, 2017. Evaluation and Research (CDER) is
I. Background After consideration of the comments announcing the following public
In recent years, regulatory authorities received and revisions to the guideline, workshop entitled ‘‘CDER and You:
and industry associations from around a final draft of the guideline was Keys to Effective Engagement.’’ The
the world have participated in many submitted to the ICH Assembly and purpose of the public workshop is to
important initiatives to promote endorsed by the regulatory agencies in build upon previous efforts to help
international harmonization of August 2017. advocates understand how they can
regulatory requirements under the ICH. The guidance consists of questions engage with FDA to enhance drug
FDA has participated in several ICH and answers that were developed to development and safety. This marks the
meetings designed to enhance clarify the principles for selecting third annual CDER public workshop for
harmonization and FDA is committed to starting materials described in the ICH patient advocacy groups.
seeking scientifically based harmonized guidance ‘‘Q11 Development and
DATES: The public workshop will be
technical procedures for pharmaceutical Manufacture of Drug Substances,’’
held on April 3, 2018, from 8 a.m. to 3
development. One of the goals of published November 20, 2012 (77 FR
p.m.
harmonization is to identify and reduce 69634). The guidance provides guidance
on selecting and justifying starting ADDRESSES: The public workshop will
differences in technical requirements for
drug development among regulatory materials, in particular for the synthesis be held at the FDA White Oak Campus,
agencies. of chemical entity drug substances. 10903 New Hampshire Ave., Bldg. 31
ICH was established to provide an This guidance is being issued Conference Center, the Great Room (Rm.
opportunity for harmonization consistent with FDA’s good guidance 1503), Silver Spring, MD 20903.
initiatives to be developed with input practices regulation (21 CFR 10.115). Entrance for the public workshop
from both regulatory and industry The guidance represents the current participants (non-FDA employees) is
representatives. FDA also seeks input thinking of FDA on ‘‘Q11 Development through Building 1 where routine
from consumer representatives and and Manufacture of Drug Substances— security check procedures will be
others. ICH is concerned with Questions and Answers (Chemical performed. For parking and security
harmonization of technical Entities and Biotechnological/Biological information, please refer to https://
daltland on DSKBBV9HB2PROD with NOTICES

requirements for the registration of Entities).’’ It does not establish any www.fda.gov/AboutFDA/
pharmaceutical products for human use rights for any person and is not binding WorkingatFDA/BuildingsandFacilities/
among regulators around the world. The on FDA or the public. You can use an WhiteOakCampusInformation/
six founding members of the ICH are the alternative approach if it satisfies the ucm241740.htm.
European Commission; the European requirements of the applicable statutes FOR FURTHER INFORMATION CONTACT:
Federation of Pharmaceutical Industries and regulations. This guidance is not Chris Melton, Center for Drug
Associations; the FDA; the Japanese subject to Executive Order 12866. Evaluation and Research, Food and

VerDate Sep<11>2014 17:58 Feb 23, 2018 Jkt 244001 PO 00000 Frm 00042 Fmt 4703 Sfmt 4703 E:\FR\FM\26FEN1.SGM 26FEN1

Document Created: 2018-02-24 01:00:36
Document Modified: 2018-02-24 01:00:36

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice of availability.
Dates		The announcement of the guidance is published in the Federal Register on February 26, 2018.
Contact		Regarding the guidance: Stephen Miller, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 1446, Silver Spring, MD 20993-0002, 301-796-1418, 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.
FR Citation		83 FR 8279

83 FR 8279 - Q11 Development and Manufacture of Drug Substances-Questions and Answers (Chemical Entities and Biotechnological/Biological Entities); International Council for Harmonisation; Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 83, Issue 38 (February 26, 2018)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration