1st Systematic Regulation of ATMPs in China Released in Draft

The 1st systematic regulation of Advanced Therapy Medicinal Products (ATMPs) in China has been released for draft comments. On June 10, 2025, the Center for Drug Evaluation (CDE) released the “Scope, Classification, and Interpretation of Advanced Therapy Medicinal Products (Draft for Public Comments),” aiming to clarify the definition, classification, and regulatory framework of Advanced Therapy Medicinal Products (ATMPs) in China. This document marks a further improvement in the regulatory system for cutting-edge biopharmaceutical fields such as cell therapy and gene therapy. It is significant for promoting the development of innovative therapies, optimizing the review and approval process, and enhancing industry competitiveness.

Definition and Scope of Advanced Therapy Medicinal Products (ATMPs)

Definition

The draft defines ATMPs as medicinal products that comply with pharmaceutical management regulations, are developed, produced, operated, used, and regulated through the pharmaceutical pathway, and are produced through ex vivo manipulation to function within the human body. This means that ATMPs must meet the requirements of the “Drug Administration Law” and are distinguished from traditional small molecule or large molecule biopharmaceuticals. Their core characteristic is “ex vivo manipulation + in vivo function.”

Purpose:

Clarify regulatory guidelines: Defining the scope and classifications for various types of ATMPs in China.
Support industry development: Enhancing the development of innovative therapies and improving industry competitiveness.
Optimize approval processes: Streamlining the review and approval processes for ATMPs to encourage faster market access.

Core Content Analysis

What the “Scope, Classification, and Interpretation” Provides: The draft defines and classifies ATMPs, clarifying their scope and helping businesses align their development and regulatory strategies for market entry in China.
Regulatory Framework: The document lays out the key requirements for cell therapy, gene therapy, and other advanced biopharmaceuticals, detailing the steps companies must take to comply with Chinese regulations.
Exclusion Scope: The draft also outlines which products are excluded from ATMP regulations, ensuring clarity for manufacturers.

Impact on International Companies and Response Strategies

Impact:

Market Entry: Provides international companies with the clarity they need to navigate China’s evolving regulatory environment for ATMPs.
Regulatory Compliance: Ensures that foreign manufacturers meet China’s regulatory standards and streamline their market entry process.
Industry Competitiveness: Helps companies improve their position in China’s competitive biopharmaceutical sector.

Response Strategies:

Stay Informed: Monitor updates to ensure your business complies with the latest regulatory requirements.
Collaborate with Experts: Seek advice from regulatory consultants to navigate China’s approval processes effectively.
Tailor Regulatory Submissions: Ensure your products meet the specific requirements outlined in the CDE draft document for quicker approvals.

Regulatory Changes and Trend Analysis

Comparison with Existing Regulations:
The draft regulations are an essential step toward refining the regulatory framework for ATMPs in China, providing a more structured and transparent approach to approval processes.

Regulatory Trends:
China’s regulatory landscape for ATMPs is evolving to meet global standards, with trends pointing toward:

Streamlined Approval Processes: Efforts to shorten the regulatory timelines for ATMPs to speed up market access.
Focus on Safety and Innovation: A greater emphasis on ensuring the safety of innovative therapies while fostering innovation in treatment development.
Global Alignment: China’s regulatory framework increasingly aligning with international standards, benefiting global market access.

Further Information

To read the original announcement about the draft guidelines for Advanced Therapy Medicinal Products (ATMPs) released by the Center for Drug Evaluation (CDE), please click here.

If you are an international manufacturer with questions about how the new ATMP regulations will affect your market entry into China, please contact Cisema.