Scrip is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

U.S. FDA Issues Warning Letters To Chinese Firms As Agency Tightens Foreign Field Inspections Program

This article was originally published in PharmAsia News

Executive Summary

The agency requests 16 more inspectors in China in an effort to boost enforcement and training.

You may also be interested in...



U.S. FDA Warning Letter To Sichuan Pharma Only Tip Of The Iceberg For China State-Owned Company

WASHINGTON and SHANGHAI - U.S. FDA issued Sichuan Pharmaceutical Co., Ltd. a warning letter Sept. 9 for significant deviations from current good manufacturing practices in the manufacture of active pharmaceutical ingredients. The warning letter adds more woes to the troubled China state-owned enterprise, and the Chengdu government is looking for a basement price to unload the company

International "Comparability" Of Regulatory Standards May Be FDA's Solution To GMP Oversight

FDA may begin to rely on foreign government oversight of manufacturing even if the standards for the overseas regulators do not exactly match those in the U.S

U.S. FDA China Country Head Chris Hickey On FDA's Mission In China: An Interview With PharmAsia News (Part 2 of 2)

U.S.FDA established offices in China in 2008 to improve oversight of products exported to the U.S., and to establish stronger working relationships with China's State FDA. The mission of the office initially was to implement two export agreements signed with China in December 2007 to enhance regulatory cooperation in the areas of food, drugs, medical devices and animal feed. PharmAsia News' China and Australia bureaus spoke to FDA China Country Director Christopher Hickey about the mission of the China office and progress being made in China. This is part two of a two-part interview; part one appeared in a recent issue of PharmAsia News.

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

SC080590

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Thank you for submitting your question. We will respond to you within 2 business days. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel