Commercial Information Circulars

24-hour hotline : 23 922 922

e-mail address : enquiry@tid.gov.hk

Ref : EIC 111/2/19

17 September 2012

Dear Sirs,

Commercial Information Circular No. 747/2012

US : Electronic Submission of Food and Drug Administration Adverse Event Reports and Other Safety Information Using the Electronic Submission Gateway and the Safety Reporting Portal

The US Food and Drug Administration (FDA) issued in the Federal Register (FR) of 14 September 2012 a notice requesting comments on proposed collection of certain information. The FR notice is available at: http://www.gpo.gov/fdsys/pkg/FR-2012-09-14/pdf/2012-22659.pdf.

DETAILS

2.The FDA is soliciting comments on the use of its Electronic Submission Gateway and the Safety Reporting Portal to collect adverse event reports and other safety information for FDA-regulated products. Interested parties are invited to submit comments to the FDA by 13 November 2012

ENQUIRIES

3.For enquiries concerning this circular, please contact the undersigned at telephone number 2398 5682.

Yours faithfully,

(Miss Cindy LAU)

for Director-General of Trade and Industry

Note : While every effort is made to ensure the accuracy of the above information, the Department cannot guarantee this to be so and will not be held liable for any reliance placed on the same.