The Draft Amendment to Order 650 published by CFDA last month brings some good news around the streamlined reviews of medical device submissions in China and especially for manufacturers of Innovative Devices. Not only will manufacturers of innovative medical devices be exempted from providing proof of sales abroad to CFDA, the mandatory local type testing requirements are also abolished. Nevertheless, there still exist some challenges for the unwary.
Chinese biotech groups are on target to raise about $10bn this year from venture capital funding, initial public offerings and licensing deals with overseas pharma companies, in what is partly a bet that Chinese-developed drugs can compete globally.
An estimated 300 million Chinese people are smokers. China has also a serious issue with hazardous air pollution. Here concentrations of small, breathable particles (PM2.5) invariably exceeding 300 micrograms per cubic meter in the industrialized northern regions.
As the world’s largest generics maker, Teva still doesn’t have much of a presence in China, even though it is a country relies heavily on generics. The Israeli company is looking to remedy that by reportedly forming a joint venture with local company Guangzhou Pharma
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