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China Tightens Clinical Study Grip In Sweeping Biosecurity Law Proposal

 
• By Brian Yang

From requiring early notification to whole-process involvement, China is clearing a path for a far-reaching new biosecurity law, which if implemented will pose high hurdles for international firms planning to conduct clinical studies in the country, industry observers say.

anyaivanova/Shutterstock.com
WILL CHINA'S PROPOSED BIOSECURITY LAW DETER CLINICAL STUDIES? • Source: Shutterstock

In May, China's State Council released a draft of a strengthened Biosecurity Law, and the second edition of the legislation is set to oversee a broad spectrum of issues ranging from public health outbreaks to biosciences research, from biolabs to biodiversity to bioweapons.

It has already ignited hot debate over the collection and use of human genes and other biomaterials in the world’s

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• By Anju Ghangurde

As the US FDA expands unannounced foreign inspections building on pilots in India and China, experts expect higher scrutiny of overseas sites and perhaps even an industry shakeout in the longer term, though staffing and enforcement challenges could slow things down.

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Elevar/Hengrui’s Second US CRL A Bad Omen For Multiregional Trials In Asia-Dominant Cancers?

 
• By Dexter Jie Yan

While CMC glitches linger over a US NDA for Elevar/Hengrui’s novel liver cancer combination following a second complete response letter, the separate issue of underrepresentation of US patients in multiregional trials is looming large after new FDA draft guidance last year.

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