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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.

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More from China

China Plans Clinical Data Protection By Product Category For First Time

 
• By Xu Hu

After almost seven years, China’s NMPA has once again published draft measures for clinical trial data protection, opening these up to public comments. While specific protection periods by drug category are proposed, some clarifications are still needed.

China Approvals Rise But Conditional-To-Full Conversion Slips

 
• By Xu Hu

A new annual report from China's CDE shows a rise in overall product approvals but a fall in the transition rate for conditional to full approvals, possibly signalling more stringent requirements.

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letter, the separate issue of underrepresentation of US patients in multiregional trials is looming large after new FDA draft guidance last year.

China Signals Commercial Insurance, Biotech And Foreign-Owned Hospitals As Policy Priorities

 
• By Xu Hu

The main 2025 policy priorities for China's government as outlined in an annual report will include the strengthening of commercial insurance for innovative drugs and opening up cell and gene therapy and the hospital sector to foreign investment.

More from Asia

Japan Identifies Drugs ‘In Urgent Need’ Of Development

 
• By Lisa Takagi

Artesunate for malaria, TB drug pretomanid and omadacycline for pneumonia and skin infections are among the drugs identified by Japanese regulatory authorities in urgent need of domestic development.

US Tariff Impact On Korea Dissected As Country Gears For Presidential Election

 
• By Jung Won Shin

Analysts expect a limited impact on South Korean pharma from US tariffs, even if imposed at a later date. Meanwhile, the early June domestic presidential election is set to determine the direction of policies in the sector.

Trump Tariffs: Indian Pharma Dodges Bullet, But Sword May Remain

 
• By Vibha Ravi

Trump announced a 26% reciprocal tariff on India, but a country-agnostic exemption of pharmaceuticals implies that the interests of Indian firms are protected for now. What is Indian pharma’s business exposure and what is domestic industry saying?