Author Archives: wesley

Policy Analysis & Guidance: China’s Drug Procurement Office Cancels Qualification for Non-Compliant Drug

China’s National Joint Procurement Office (NJPO) has canceled the centralized procurement qualification of Peramivir Injection, produced by Shanxi Yanghe Pharmaceutical Technology Co., Ltd. and entrusted to Shanxi Guorun Pharmaceutical Co., Ltd., following a regulatory crackdown on non-compliant production practices.

Policy Breakdown

Non-Compliance Identified: The National Medical Products Administration (NMPA) found the drug to violate Good Manufacturing Practice (GMP) standards, leading to a production suspension order.
Penalties Imposed: Both companies involved were added to a “blacklist” and barred from participating in national drug procurement activities until October 2026.
Substitution Mechanism: Provinces affected by the disqualification must activate backup supply procedures as per procurement guidelines.

Market Implications
The decision underscores China’s zero-tolerance policy for quality violations, potentially delaying market access for non-compliant drugs by 12–18 months. Analysts at China Healthcare Regulatory Institute highlight the move as a deterrent to substandard production practices.

Industry Impact
Pharmaceutical firms are urged to prioritize GMP compliance to avoid disruptions in supply chains and procurement qualifications. The incident serves as a reminder of the risks associated with contract manufacturing arrangements.

Looking Ahead
The NJPO is expected to intensify audits of contract manufacturing relationships, with a focus on quality system alignment. Stakeholders should monitor how substitution procedures impact regional drug availability and pricing.-China Health Reform Pulse

Policy Source: https://www.smpaa.cn/gjsdcg/2025/04/07/16524.shtml

Policy Analysis & Guidance: China’s Patient-Centric Rare Disease Drug Development Pilot

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

Policy Analysis & Guidance: China’s Drug Review Center Enhances Industry Support via Online Seminars

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