How Will China Regulate and Boost Pharmaceutical Industry by 2025

by Grace Wang Jan 14, 2022

At the end of 2021, China announced its National Plan for Promoting Drug Safety and the High-quality Development of the Pharmaceutical Industry during the 14th Five-Year Plan (2021-2025).

To realize the 2035 vision which includes an internationally-advanced drug regulatory system, China sets tasks to be completed by 2025.

The tasks cover how drug regulators will improve their capabilities and regulate the pharmaceutical industry.

One of the significant tasks is to make and amend 2,000 drug standards and 100 technical guidelines1, so drug makers will have more detailed criteria to follow. China will also digitalize the Chinese Pharmacopoeia so that drug makers can check out specific criteria more easily.

Besides, China will randomly inspect 130 to 150 drug products every year, emphasizing NRDL-listed drugs, imported chemical drugs, pediatric drugs, and TCM decoction slices.

While upholding strict quality standards and rules, China will maintain flexibility in drug review and approval procedures. For example, for drugs that are eligible for Breakthrough Therapy Designation, Conditional Approval, Priority Review, or Special Approval, the National Medical Products Administration (NMPA) will expedite the review.

RELATED: Four Expedited Programs for Drug Registration in China

Grace Wang
ChemLinked Regulatory Analyst
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