China’s National Medical Products Administration (NMPA) has registered 91 Class I medical devices in March 2025, reflecting ongoing efforts to streamline regulatory processes and accelerate market entry for international firms. The registrations span a wide range of products, from surgical instruments to diagnostic reagents, underscoring China’s commitment to efficient and transparent oversight.

Policy Breakdown

• Registration Volume: The 91 registrations include products like surgical tools, orthopedic devices, and laboratory consumables, highlighting diverse market needs.
• International Participation: Companies from South Korea, Germany, and the U.S. feature prominently, indicating sustained foreign interest in China’s medical device sector.
• Dynamic Updates: Several entries reflect amended registration details, demonstrating the NMPA’s flexibility in managing product lifecycle changes.

Market Implications
The efficient registration process signals China’s push to solidify its position as a global hub for medical innovation. Analysts at China Healthcare Market Research estimate that streamlined approvals could reduce time-to-market by 10–15% for compliant international products.

Industry Impact
Medical device firms are encouraged to leverage China’s expedited review pathways, particularly for products addressing unmet clinical needs. The move also underscores the importance of adhering to local regulatory standards to avoid supply disruptions.

Looking Ahead
As China continues refining its registration framework, stakeholders should monitor how emerging technologies and shifting clinical demands shape future regulatory priorities. The next registration cycle is expected in Q2 2025.-China Health Reform Pulse

Policy Source: https://www.nmpa.gov.cn/ylqx/ylqxjgdt/20250410091256105.html

China’s National Medical Products Administration (NMPA) has approved Shanghai BeliefDelivery BioMed Co Ltd’s BBM-H901 injection (brand name: Xinjiu Ning) for the treatment of adult patients with moderate to severe hemophilia B. The move highlights China’s commitment to advancing gene therapy and providing new treatment options for rare diseases.

Policy Breakdown

• Approval Mechanism: The drug was approved through an expedited review process, reflecting the NMPA’s focus on accelerating access to innovative therapies.
• Therapeutic Innovation: BBM-H901 is a recombinant adeno-associated virus (rAAV) vector gene therapy product that delivers the FIX gene to target cells (primarily liver cells) to express FIX.
• Market Implications: The approval offers a new treatment paradigm for hemophilia B patients, potentially reducing the burden of frequent infusions and improving quality of life.

Market Implications
The approval signals China’s growing role as a hub for gene therapy innovation. Analysts at China Healthcare Innovation Institute estimate that the market for hemophilia treatments could expand by 15–20% with the introduction of gene therapies.

Industry Impact
Pharmaceutical companies are encouraged to leverage China’s supportive regulatory environment to advance similar therapies. The move underscores the government’s push for high-quality development in the pharmaceutical sector, as outlined in the 14th Five-Year Plan for National Drug Safety and High-Quality Development.

Looking Ahead
Stakeholders should monitor how the NMPA’s expedited review pathways and gene therapy guidelines evolve to support further innovation. The long-term goal is to create a more conducive environment for the development and commercialization of advanced therapies.-China Health Reform Pulse

Policy Source: https://www.nmpa.gov.cn/zhuanti/cxylqx/cxypxx/20250410095314169.html

China’s Center for Drug Evaluation (CDE) has released draft guidelines for the pharmaceutical common issues of recombinant adeno-associated virus (rAAV) vectors used in in vivo gene therapy products. The move aims to enhance R&D norms and accelerate the registration and high-quality development of domestic rAAV products.

Policy Breakdown

• Objective: The draft guidelines address key technical and regulatory questions to streamline the review process for gene therapy products.
• Consultation Period: Stakeholders have one month from the release date to submit feedback, reflecting the CDE’s commitment to inclusive regulation.
• Technical Focus: Guidelines cover critical aspects such as vector construction, quality control, and stability testing, providing clarity for developers navigating this complex space.

Market Implications
The initiative is expected to reduce regulatory uncertainty, potentially accelerating time-to-market for innovative gene therapies by 15–20%. Analysts at China Healthcare Innovation Institute highlight improved review predictability as a key driver for investment in the sector.

Industry Impact
Gene and cell therapy developers are encouraged to align with the emerging standards to ensure smoother registration processes. The guidelines underscore China’s push to establish itself as a global hub for advanced therapy development.

Looking Ahead
The finalized guidelines, expected by mid-2025, will likely shape the technical requirements for upcoming gene therapy applications. Stakeholders should actively engage in the consultation to influence the final framework.-China Health Reform Pulse

Policy Source: https://www.cde.org.cn/main/news/viewInfoCommon/fca7432d3e899f564e748f6c92238cac