China's Drug Inspection Sampling Report of 2024 from NIFDC & NMPA Released

China’s Drug Inspection Sampling Report of 2024 (2024 Report) was jointly released at the end of March 2025 by the Center for Medical Device Standardization of the National Medical Products Administration (NMPA) and the National Institutes for Food and Drug Control. The 2024 Report states that 20,604 batches of 136 varieties of drugs were sample inspected in 2024. The inspection revealed a compliance rate of 99.4%, indicating a generally high level of drug quality across China. “The results of the national drug sampling in 2024 show that the current drug safety situation in China is generally stable and controllable, and the quality of drugs continues to remain at a high level,” said the 2024 Report. This sampling effort applied to formulations, raw drugs, and Chinese herbal slices, with a focus on products widely used clinically or frequently associated with adverse reactions. All overseas-produced drugs were found to be compliant.

Background

National drug sampling serves as a key regulatory tool to verify the quality and safety of pharmaceutical products post-market. It focuses on products with high clinical use, broad distribution, or quality concerns. Implemented under the Drug Quality Random Inspection and Testing Management Measures, the National Medical Products Administration (NMPA) coordinates dispersed sampling, centralized testing, and exploratory research across 50 accredited institutions. This process supports early risk detection and promotes continuous improvement in drug quality standards.

Sampling Situation

In 2024, national drug sampling covered 136 varieties (including formulations, raw drugs, and Chinese herbal slices, with specific names in Appendix 1 of the original text) and 20,604 batches, with an overall compliance rate of 99.4%, showing a high overall drug quality in China. Among them, 18,412 batches of formulations were sampled, with 18,357 batches compliant and 55 batches non-compliant; 2,192 batches of Chinese herbal slices were sampled, with 2,129 batches compliant and 63 batches non-compliant. For details, see Table 1.

Table 1: 2024 National Drug Sampling – Drug Category and Batch Distribution Drug Category Varieties (Count) Sampling Batches Total Compliant Total Compliant Non-compliant Chemical Drugs 73 59 18412 11428 55 TCM 48 40 6684 6675 9 Biologicals 5 5 254 254 0 Chinese Herbal Pieces 10 / 2192 2129 63 Total1361042060420486118

Note: / indicates data not provided in original text.

Sampling Situation

The 136 varieties sampled in the 2024 national drug sampling included 73 chemical drugs, 48 traditional Chinese drugs, 10 Chinese herbal slices, and 5 biologics; samples were collected at production (4,804 batches), distribution (14,632 batches, including 587 batches from online sales), and usage (1,168 batches) stages. For details, see Figure 1.

Drug Formulation Sampling Situation

From Table 1, we learn that 18,412 batches of drug formulations were sampled in the 2024 national drug sampling. After testing, 18,357 batches were compliant, and 55 batches were non-compliant. Among the 126 varieties sampled (excluding Chinese herbal slices), 104 varieties had all samples compliant. These included 59 chemical drug varieties (11,428 batches), 40 traditional Chinese drug varieties (6,675 batches), and 5 biologic varieties (254 batches).

1. Chemical Drugs

In 2024, national drug sampling involved 73 varieties and 11,474 batches of chemical drugs (including 17 batches of raw materials), with samples collected at production (2,657 batches), distribution (8,076 batches, including 264 batches from online sales), and usage (741 batches) stages. After testing, 11,428 batches were compliant, and 46 batches were non-compliant, with non-compliant samples detected at production (6 batches), distribution (39 batches, including 2 batches from online sales), and usage (1 batch) stages, accounting for 0.2%, 0.5%, and 0.1% of the samples in each stage, respectively.

Non-compliant items included characteristics (17 batches), identification (3 batches), tests (30 batches), and content determination (3 batches), accounting for 32.0%, 5.7%, 56.6%, and 5.7% of all non-compliant items, respectively. (See Figure 2.)

In 2024, national drug sampling covered 17 dosage forms of chemical drugs, with non-compliant samples detected in 7 dosage forms. These included tablets (4 batches), injections (8 batches), capsules (17 batches), ophthalmic preparations (12 batches), creams (2 batches), oral solutions (2 batches), and enemas (1 batch), accounting for 0.1%, 0.2%, 1.1%, 2.3%, 0.3%, 0.5%, and 0.3% of the samples in each dosage form, respectively. (See Figure 3.)

2. Traditional Chinese Drugs

In 2024, national drug sampling involved 48 varieties and 6,684 batches of traditional Chinese drugs, with samples collected at production (1,089 batches), distribution (5,548 batches, including 323 batches from online sales), and usage (47 batches) stages. After testing, 6,675 batches were compliant, and 9 batches were non-compliant, with non-compliant samples detected at production (3 batches) and distribution (6 batches) stages, accounting for 0.3% and 0.1% of the samples in each stage, respectively. Non-compliant items included characteristics (1 batch), tests (7 batches), and content determination (1 batch), accounting for 11.1%, 77.8%, and 11.1% of all non-compliant items, respectively. In 2024, national drug sampling covered 7 dosage forms of traditional Chinese drugs, with non-compliant products detected in 4 dosage forms, namely tablets (1 batch), capsules (1 batch), granules (3 batches), and pills (4 batches), accounting for 0.1%, 0.1%, 0.2%, and 0.2% of the samples in each dosage form, respectively.

3. Biologics

In 2024, national drug sampling involved 5 varieties and 254 batches of biologics, with samples collected at production (82 batches), distribution (149 batches), and usage (23 batches) stages. These included 4 therapeutic biologics and 1 preventive biologic. After testing, all inspected items were compliant.

4. National Essential Drugs

In 2024, national drug sampling involved 31 varieties and 6,332 batches of national essential drugs (excluding Chinese herbal slices), with samples collected at production (1,615 batches), distribution (4,372 batches, including 198 batches from online sales), and usage (345 batches) stages. After testing, 6,307 batches were compliant, and 25 batches were non-compliant, with non-compliant products detected at production (2 batches), distribution (22 batches, including 2 batches from online sales), and usage (1 batch) stages, involving 6 dosage forms. Sampling results showed an overall good quality of national essential drugs.

5. Varieties Selected in National Centralized Drug Procurement

In 2024, national drug sampling involved 24 varieties and 4,522 batches of varieties selected in national centralized drug procurement, with samples collected at production (1,253 batches), distribution (2,884 batches, including 86 batches from online sales), and usage (385 batches) stages. These covered 7 dosage forms, including tablets (1,879 batches), injections (1,783 batches), capsules (414 batches), granules (194 batches), ophthalmic preparations (159 batches), syrups (2 batches), and oral suspensions (87 batches), plus 4 batches of raw materials. The 4,522 batches included 4,312 batches of domestic drugs from 407 manufacturers and 210 batches of overseas-produced drugs from 30 manufacturers. After testing, all inspected items of the selected enterprises in the national centralized drug procurement were compliant.

6. Overseas-Produced Drugs

In 2024, national drug sampling involved 399 batches of overseas-produced drugs, covering 11 dosage forms. Samples were collected at production (22 batches), distribution (349 batches, including 6 batches from online sales), and usage (28 batches) stages. After testing, all inspected items were compliant.

Application of Sampling Results

Drug sampling is crucial for risk prevention, standardizing production, and ensuring drug quality. It also helps improve drug quality and upgrade the industry.

System Development: In 2024, the "Principles and Procedures for Exploratory Research in Drug Sampling" were issued, and the "Measures for Drug Quality Random Inspection and Testing" and related documents were revised. Procedures for sampling online - sold drugs were explored, and the sampling mechanism was improved.

Special Projects: A special project on contract manufacturing was set up to strengthen supervision of such varieties. An online drug sales sampling model was explored to examine quality differences between online and offline drugs, and monitoring of Chinese herbal drug quality was enhanced with provincial monitoring requirements proposed for the first time.

Risk Prevention: Provincial MPA were organized to take immediate action on non-compliant products, such as sealing, impounding, suspending sales and use, and recalling. Related enterprises and units were investigated and required to rectify. On - site inspections were conducted for enterprises potentially involved in illegal activities, and measures were taken to control risks. Risk warning letters were also issued, and exploratory research results were shared to urge enterprises to improve and enhance industry quality.

Further Information

To read the original NMPA announcement for national drug sampling result, please click here.

If you are a pharmaceutical manufacturer with questions about how the national drug sampling results may impact your product registration or compliance requirements in China, please contact Cisema.