China’s Center for Drug Evaluation (CDE) has launched a public consultation on its 2025 external expert roster, aiming to enhance the scientific rigor and impartiality of its drug review process. The move reflects the CDE’s ongoing efforts to build a transparent and credible regulatory framework.

Policy Breakdown

• Objective: The consultation, running from April 9 to April 17, seeks feedback on the proposed expert panel, which will support reviews of innovative and complex drug applications.
• Mechanism: Stakeholders can submit objections via email during the consultation period, ensuring accountability and public oversight.
• Regulatory Basis: The initiative adheres to the Interim Measures for the Management of External Experts of the National Medical Products Administration, emphasizing qualification reviews and procedural integrity.

Market Implications
The expanded expert panel is expected to accelerate reviews of high-priority applications, particularly for novel therapies and rare disease treatments. Analysts at China Healthcare Innovation Institute highlight improved review quality as a key benefit for both domestic and international developers.

Industry Impact
Pharmaceutical companies are encouraged to engage with the consultation process to ensure diverse expertise informs regulatory decisions. The move underscores China’s commitment to aligning its drug review practices with global standards.

Looking Ahead
The CDE plans to finalize the expert roster by mid-April, with the new panel expected to take effect immediately. Stakeholders should monitor how the expanded expertise influences review timelines and scientific guidance availability.-China Health Reform Pulse

Policy Source: https://www.cde.org.cn/main/news/viewInfoCommon/0bb5c2dd641e1438f164ad855460b852

China’s Center for Drug Evaluation (CDE) has officially included Eliglustat Tartrate Capsules in its patient-centric rare disease drug development pilot program, known as the “Care Program.” The move highlights China’s commitment to accelerating treatments for rare diseases, starting with Gaucher disease.

Policy Breakdown

• Drug & Indication: Eglystat Tartrate Capsules, developed by Beijing Kailai Tiancheng Medical Technology Co., Ltd., target Type I Gaucher disease, a rare genetic disorder.
• Development Stage: The drug is in the post-marketing (E stage) phase, focusing on patient experience data collection and preference analysis.
• Patient-Centric Approach: The pilot emphasizes direct patient input through surveys and data analysis to tailor future treatments.

Market Implications
The inclusion in the Care Program signals regulatory prioritization, potentially shortening time-to-market for rare disease therapies. Analysts at China Healthcare Innovation Institute estimate a 20–30% reduction in development timelines for drugs in the program.

Industry Impact
Pharmaceutical companies are encouraged to engage with patient communities early in the development cycle, aligning with China’s shift toward patient-centered regulatory frameworks.

Looking Ahead
The Care Program is expected to expand to include additional rare disease treatments, with a focus on leveraging real-world data for regulatory decisions. Stakeholders should monitor how patient feedback shapes clinical trial designs and approval processes.-China Health Reform Pulse

Policy Source: https://www.cde.org.cn/main/news/viewInfoCommon/a1b306badd16f4f4e16360e3ce4522ba