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Access Pains After Approval In China? Consider The 'Three Ps'

 
• By Brian Yang

Still a largely self-pay market, China is in the middle of a new drug approvals rush with 48 clearances in 2018 and more pending, forcing manufacturers to innovate their access models. Among several emerging strategies, a "Three P" combination of pricing, private insurance and patient assistance seems to be winning the day.

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'Three P' Strategy For High-Priced New Drugs In China • Source: Shutterstock

When a new drug gains approval in China, the road to the market is just beginning.

With the country poised to introduce many newly approved products including anticancers and anti-infectives to the market, making these accessible to patients isn’t as straightforward as in other countries.

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BIOSECURE Act Returning, Privacy, Gain-of-Function Bills Coming, Senate Sponsor Says

 
• By Laura Helbling

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China Plans Clinical Data Protection By Product Category For First Time

 
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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

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DIA Korea: Medical Turmoil, Global Factors Blunt Korea’s Trial Edge

 
• By Jung Won Shin

DIA Korea hears how multiple domestic and global factors are affecting the environment for clinical trials in South Korea, and what actions may be taken to address this.

India Signals ‘Systemic Changes’ In CGT Regulatory Approach

 
• By Anju Ghangurde

India is pressing ahead with “big shifts” in its regulatory approach for cell and gene therapies. Reduced “layers of review”, tighter internal timelines, upcoming guidelines to facilitate CGT development and reforms in the constitution of expert committees are some of the key changes.