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International Council for Harmonization Regional Public Consultation

The FDA will be hosting a regional public consultation on May 6 to solicit public input prior to the next meeting of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use on June 11-16, 2016. The ICH's mission is to achieve greater harmonization worldwide to ensure that safe, effective, and high quality medicines are developed and registered in the most resource-efficient manner. Experts from the Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research attend ICH meetings twice per a year, before each meeting the FDA conducts a public consultation to allow the public to comment on the topic areas. The topic areas relate to harmonization of various guidelines for the manufacture of pharmaceuticals.

An agenda will be posted closer to the date of the event.


May 6, 2016


9:00 AM to 12:00 PM


10903 New Hampshire Avenue
Building 31 Rm 1503A
Silver Spring, MD 20993


To register to attend this event, either in person or via the web, visit the event registration pagedisclaimer icon.

For more information on traveling to the White Oak campus: visit Public Meetings at the FDA White Oak Campus

Submitting comments to the docket:

In addition to providing input at the public meeting, the public is invited to provide comments through the public docket. The docket will close on June 6, 2016.

Visit the following website to submit your comment: https://www.regulations.gov/#!documentDetail;D=FDA-2016-N-1112-0001

Federal Register Notice

Webcast Information:

International Council for Harmonization Regional Public Consultation US FDA and Health Canada(PDF - 2046KB)

For questions regarding the meeting please contact:

Amanda Roache
Office of Strategic Programs
Center for Drug Evaluation and Research
Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
Email: Amanda.Roache@fda.hhs.gov


Meeting Materials