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Bigger, Bolder, SMAR: Decoding China's All-In-One Regulatory Agency

 
• By Brian Yang

A new era began April 10 with disappearance of China FDA and kickoff of State Administration for Market Regulation (SMAR), the so-called 'One-Stop' regulatory agency. Will the CFDA's innovation-encouraging policies continue? How will the new agency balance innovation and enforcement? Pink Sheet offers preliminary answers to these key questions and decode the new SMAR from five important aspects.

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DECODING CHINA'S NEW REGULATORY AGENCY

One month after a massive re-organization announcement, the curtain falls on the China FDA, China's food and drug regulatory agency. On April 10, a new agency, the State Administration for Market Regulation (SAMR) began.

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China Plans Clinical Data Protection By Product Category For First Time

 
• By Xu Hu

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China Approvals Rise But Conditional-To-Full Conversion Slips

 
• By Xu Hu

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• By Dexter Jie Yan

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

 
• By Xu Hu

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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?