[Federal Register Volume 80, Number 17 (Tuesday, January 27, 2015)]
[Notices]
[Pages 4282-4283]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-01406]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-D-0068]
International Conference on Harmonisation; S10 Photosafety
Evaluation of Pharmaceuticals; Guidance for Industry; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a guidance for industry entitled ``S10 Photosafety
Evaluation of Pharmaceuticals.'' The guidance was prepared under the
auspices of the International Conference on Harmonisation of Technical
Requirements for Registration of Pharmaceuticals for Human Use (ICH).
This guidance outlines details on when photosafety testing is warranted
and on possible assessment strategies; it should be read in conjunction
with the ICH M3(R2) guidance, section XIV(14) Photosafety Testing. The
purpose of the guidance is to recommend international standards for
photosafety assessment and to harmonize such assessments that support
human clinical trials and marketing authorization for pharmaceuticals.
This guidance finalizes the draft guidance issued on February 4, 2013.
DATES: Submit either electronic or written comments on Agency guidances
at any time.
ADDRESSES: Submit written requests for single copies of the guidance to
the Division of Drug Information, Center for Drug Evaluation and
Research (CDER), Food and Drug Administration, 10001 New Hampshire
Ave., Hillandale Building, 4th Floor, Silver Spring, MD 20993; 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. See the SUPPLEMENTARY INFORMATION section for electronic
access to the guidance document.
Submit electronic comments on the 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: Abigail
Jacobs, Center for Drug Evaluation and Research, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 6474, Silver
Spring, MD 20993-0002;
Regarding the ICH: Michelle Limoli, Center for Drug Evaluation and
Research, International Programs, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 51, Rm. 1174, 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
[[Page 4283]]
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 the United States.
The six 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; and the Pharmaceutical
Research and Manufacturers of America. 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, Health Canada, and the European Free Trade Area.
In the Federal Register of February 4, 2013 (78 FR 7786), FDA
published a notice announcing the availability of a draft guidance
entitled ``S10 Photosafety Evaluation of Pharmaceuticals.'' The notice
gave interested persons an opportunity to submit comments by March 21,
2013. Changes made to the guidance took into consideration written
comments received. In addition to editorial changes primarily for
clarification, the major changes are as follows:
The guidance further emphasizes the flexibility and
optional nature of assessments for photosafety. This is reflected in
revisions to Figure 1 and related text.
The discussion about pharmaceuticals given via ocular
routes was reduced because the ICH working group did not have useful
guidance to provide for these products.
After consideration of the comments received and revisions to the
guidance, a final draft of the guidance was submitted to the ICH
Steering Committee and endorsed by the three participating regulatory
Agencies in November 2013.
The ICH S10 guidance provides guidance on when photosafety testing
is warranted, and on possible testing strategies. It represents the
consensus that exists regarding assessment of photosafety to support
clinical development and marketing authorization of pharmaceuticals. It
supplements the ICH M3(R2) guidance,\1\ which: (1) Provides certain
information regarding timing of photosafety testing relative to
clinical development and (2) recommends that an initial assessment of
photoreactive potential be conducted and, if appropriate, an
experimental evaluation be undertaken before exposure of large numbers
of subjects.
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\1\ See the ICH guidance ``M3(R2) Nonclinical Safety Studies for
the Conduct of Human Clinical Trials and Marketing Authorization for
Pharmaceuticals,'' available on the Internet at http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm.
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The guidance describes a flexible, integrated process that involves
photochemical characteristics, data from nonclinical studies, and human
safety information. Although the strategy is flexible and the options
selected are the developer's choice, characterization of the
ultraviolet-visible absorption spectrum is recommended as the initial
assessment and can obviate any further photosafety evaluation. Results
of the evaluation determine the need for risk minimization measures to
prevent adverse events in humans.
This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
Agency'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. An alternative approach may be used if such approach 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/default.htm.
Dated: January 22, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-01406 Filed 1-26-15; 8:45 am]
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