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Stay Calm And Quickly Carry On: Five Takeaways As China FDA Builds Capabilities

 
• By Brian Yang

Growing its reviewers from 120 to 800 in a short time, the China FDA is now struggling with its very existence. After a productive year filled with over 30 new drug approvals, China's top drug regulatory agency, in its first annual report since massive regulatory reforms were announced, highlights five major trends to watch in 2018.

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After a busy year filled with regulatory reforms to erase a lengthy drug approval lag, and speed up new drug approvals, China FDA officials finally have a moment to reflect on what's good, what's bad and what's ugly.

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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

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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?