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