Insider Analysis From Asia Pacific Bio Intelligence LLC On China State FDA’s Medical Device Regulations
This article was originally published in PharmAsia News
Executive Summary
For China’s State FDA, 2011 was a banner year, with regulations released on good manufacturing practices for both drugs and devices. Multinational companies should take notice and be sure their operations are in compliance.
You may also be interested in...
New Guidelines Shed Light On Private Investment In China Hospitals
SHANGHAI - China's capital Beijing and Zhejiang Province recently issued long-awaited guidelines to encourage private investment in medical institutions, which is viewed by analysts as a signal that China will implement the policy nationwide and open the gates for private hospitals
What Multinational Companies Need To Know About China's New GMP Regs - Webinar (Part 2 of 2)
SHANGHAI - China's new good manufacturing practices regulations that went into effect March 1 significantly raise drug manufacturing standards in almost all areas, and shift the focus of China GMPs to a risk-based quality approach. But more importantly, the new regs indicate how China's State FDA views GMPs and the specific areas that will see more regulatory focus
China Beefs Up Quality Control System With New GMP Regulations: Shanghai FDA Leaders At PharmAsia Summit
SAN FRANCISCO - China is releasing a new edition of its good manufacturing practice regulations and introducing other measures to strength its pharmaceutical quality control system. China's State FDA is placing more focus on reviewing drugs for approval while provincial-level regulators have stepped-up responsibility for inspecting drug makers and monitoring drugs on the market, said Shanghai FDA officers who spoke at the PharmAsia Summit this week in San Francisco