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

China’s Drug Review Center (CDE) hosted its third “Cloud Classroom” seminar on March 7, focusing on key technical issues in oncology drug development and interpreting newly released regulatory guidelines. The event drew over 10,000 participants from regulatory bodies and pharmaceutical companies, reflecting growing industry demand for technical guidance and policy clarity.

Key Highlights

• Technical Focus: Experts addressed critical topics such as dose selection strategies, clinical considerations for combination therapies, and development strategies for oncology drugs, using real-world review cases to provide actionable insights.
• Regulatory Training: The seminar included detailed interpretations of the newly released Chemical Drug Registration Acceptance Review Guidelines and Biological Product Registration Acceptance Review Guidelines, emphasizing documentation requirements and application review checkpoints.
• Interactive Q&A: Common questions collected during registration and live sessions were addressed, enhancing clarity for applicants on complex topics.

Market Implications
The initiative underscores the CDE’s shift toward proactive industry support, potentially reducing time-to-market for innovative drugs by 10–15%. Analysts at China Healthcare Innovation Institute highlight improved regulatory predictability as a key driver for foreign and domestic investment in R&D.

Industry Impact
Pharmaceutical developers are encouraged to leverage the CDE’s guidance to optimize clinical trial designs and streamline registration processes. The move reflects China’s broader strategy to position itself as a global hub for innovative drug development.

Looking Ahead
Future Cloud Classroom sessions will prioritize feedback-driven content design, with a focus on emerging technical and regulatory challenges. Stakeholders are advised to engage with the platform to shape upcoming agendas and access critical training resources.-China Health Reform Pulse

Policy Source: https://www.cde.org.cn/main/newspic/view/4405c914dfa20b3bf6348a644ed8bbd2