China’s 2009 Regulatory Changes Affect Drug, API And Device Makers
This article was originally published in The Pink Sheet Daily
Executive Summary
Tagging drugs, including imports, for electronic tracking starts in 2009, as do voluntary post-market studies that could portend a mandate.
You may also be interested in...
2008 In Review: China’s Major Legal & Regulatory Changes For Healthcare Sector
BEIJING - In a review of the major legal and regulatory measures that changed China's healthcare landscape in 2008, Chinese and European lawyers stated the merger of the State FDA into the Ministry of Health is likely to have the most significant impact into the future
China Paring Down Essential Medicines List In Sweeping Health System Reforms
[Editor's note: This is part three in a new series on China's wide-ranging plans to reform the country's health system, including its hospitals, insurance schemes, and access to medicines. Part one in the series appeared in PharmAsia News Oct. 30, 2008, and part two appeared Nov. 13, 2008.]
U.S. FDA Set To Strengthen Inspections Of Chinese Drugmakers, Search For Adulterants In Aftermath Of Heparin Deaths – CDER Official
BEIJING - As U.S. FDA leaders select inspectors to deploy across three new offices being set up in China, the organization is also preparing to ramp up the number of inspections and the level of scrutiny of Chinese drugmakers that export to the U.S