TCM-based new drug discovery and development in China

Area of Science:

• Pharmacology
• Drug Development
• Regulatory Science

Background:

• China's drug development environment has seen significant policy-driven improvements over 30 years.
• The regulatory system for new drug evaluation and registration has evolved towards international standards.
• Traditional Chinese Medicine (TCM) approval processes now match the rigor of chemical and biological drug regulations.

Purpose of the Study:

• To review the advancements in Traditional Chinese Medicine (TCM)-based new drug discovery and development in China.
• To outline the current regulatory landscape for TCM drug approval.
• To categorize TCM-based drug development according to established TCM classifications.

Main Methods:

• Review of policies and regulatory frameworks for drug approval in China over the past three decades.
• Analysis of the evolution of drug evaluation and registration systems.
• Categorization of TCM-based drug discovery and development approaches.

Main Results:

• China has established robust policies enhancing its drug development environment.
• The regulatory system for new drugs, including Traditional Chinese Medicine (TCM), aligns with international standards.
• TCM drug approval and registration are now as stringent as for chemical and biological products.

Conclusions:

• China's regulatory reforms have significantly modernized drug development, particularly for Traditional Chinese Medicine (TCM).
• The harmonization with international standards ensures the quality and safety of newly approved drugs.
• This review provides a structured overview of TCM-based drug development within a reformed regulatory context.