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

China will continue encouraging the following drugs to enter priority review:

  • innovative drugs with great clinical value;

  • drugs with urgent clinical needs, e.g., drugs for acquired immunodeficiency syndrome (AIDS), malignant tumors, major infectious diseases, and rare diseases;

  • pediatric drugs.

RELATED: List of Overseas New Drugs Urgently Needed in China's Clinical Settings

Generic drugs with urgent clinical needs will also be encouraged by authorities, which require generics to keep referencing the RLDs to achieve bioequivalence in the quality and efficacy consistency evaluations.

RELATED: Catalog of Reference Listed Drugs (RLDs) in China

For international drug makers, the good news is that China will explore regulatory innovations and pilot special policies in the Beijing-Tianjin-Hebei region, the Greater Bay Area, the Yangtze Delta Economic Zone, the Yangtze River Economic Belt, Chengdu-Chongqing Economic Circle, etc.

In these areas, drug makers will possibly enjoy regional preferential policies. For instance, drugs sold in Hong Kong can also be sold in the nine mainland cities in the Greater Bay Area, even if the drugs have not been approved by China's national-level drug regulator NMPA.

RELATED: New Market Entry Pathways of Medical Products: Special Medical Zones in China

In general, the plan shows that China will spare no effort to pursue drug safety and high quality. Meanwhile, Chinese authorities try to boost the pharmaceutical industry with favorable policies. Thus, compliance challenges and market opportunities will coexist for pharmaceutical companies.

Contact BaiPharm for market information and regulatory compliance services. Our strengths:

  • Experienced in preparing ANDA, CTA/IND, BLA, BE studies, MRCTs, NDA documentation; filing DMFs for APIs, excipients, and packaging materials.

  • Having a global network of offices, business representatives and experts across China, Japan, South Korea, the US, and Europe to offer 24-hour services to clients.

  • Providing multi-language translation services covering Chinese, English, Korean, Japanese, German, and Italian.

Grace Wang
ChemLinked Regulatory Analyst
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