Circular of the National Medical Products Administration on Issuing the Administrative Measures for Drug Quality Spot Checks

Circular of the National Medical Products Administration on Issuing the Administrative Measures for Drug Quality Spot Checks

Guo Yao Jian Yao Guan [2019] No. 34

August 12, 2019

Medical products administrations of all provinces, autonomous regions and municipalities directly under the Central Government, the Medical Products Administration of Xinjiang Production and Construction Corps, and the National Institutes for Food and Drug Control,

The National Medical Products Administration organized the revision of the Administrative Measures for Drug Quality Spot Checks in order to strengthen the drug supervision and administration and regulate the work of drug quality spot checks. It is hereby issued to you for implementation.

The Administrative Provisions on Drug Quality Spot Checks (Guo Shi Yao Jian Shi [2006] No. 379) issued by the former State Food and Drug Administration shall be repealed simultaneously.

Administrative Measures for Drug Quality Spot Checks

Chapter I General Provisions

Article 1 These Measures are formulated in accordance with the Drug Administration Law of the People's Republic of China and the Implementing Regulations of the Drug Administration Law of the People's Republic of China in order to regulate the work of drug quality spot checks.

Article 2 These Measures shall apply to the quality spot checks conducted by medical products administrations of the drugs which are manufactured, distributed and used subject to approval within the territory of the People's Republic of China.

Article 3 Drug quality spot check is a technical means for supervision over the post-marketing drugs and shall be carried out based on the principles of scientificity, standardization, legality and impartiality.

Article 4 The medical products administration under the State Council shall be responsible for organizing the implementation of national drug quality spot checks, carry out spot checks of the drug quality in the links of manufacture, distribution and use throughout the country, and provide guidance for local drug quality sport checks.
Provincial medical products administrations shall be responsible for carrying out spot checks of the drug quality in the link of manufacture, wholesale and retail chain headquarters and online sales on third-party platforms within their respective administrative regions, organize the departments under the people's governments at the city or county level in charge of drug supervision and administration to carry out spot checks of the drug quality in the links of retail and use within their respective administrative regions, and undertake the drug quality spot check tasks assigned by the medical products administrations at a higher level.

Article 5 Drug testing institutions established or determined by medical products administrations shall undertake the testing tasks required for drug quality spot checks.

Article 6 Entities and relevant personnel engaging in drug manufacture, distribution and use shall, in accordance with these Measures, accept the drug quality spot checks which are implemented under the organization of medical products administrations, and shall not interfere with, obstruct or refuse such spot checks, transfer or conceal drugs, refuse to provide supporting materials, or purposely provide false materials.

Article 7 Drug quality spot checks may be generally divided into supervision spot checks and evaluation spot checks on the basis of regulatory purposes. Supervision spot checks refer to the spot checks conducted by medical products administrations of the drugs with questionable quality in light of the needs for supervision; evaluation spot checks refer to the spot checks conducted by medical products administrations to evaluate the drug quality status of certain category or in certain area.

Chapter II Plan Making

Article 8 The medical products administration under the State Council and provincial medical products administrations shall develop annual plans for drug quality spot checks, and make arrangements and deployments for drug quality spot checks according to the requirements of specific targets, focus on key points, overall consideration and effective coverage.
The plans for drug quality spot checks developed by provincial medical products administrations shall connect with the plan for national drug quality spot checks. The two kinds of plans shall have their respective focus and avoid repetition while expanding the coverage.

Article 9 The departments under the people's governments at the city or county level in charge of drug supervision and administration shall, according to the plans developed by the medical products administrations at a higher level and in light of actual conditions, work out the implementing plans for drug quality spot checks within their respective administrative regions. The implementing plans shall highlight the requirements of territorial drug supervision.

Article 10 The medical products administrations that organize spot checks may, in light of changes in supervision, adjust the plans for drug quality spot checks.

Article 11 The plans for drug quality spot checks developed by medical products administrations may take the following drugs as the key objects of spot checks:
1. drugs manufactured by manufacturers within the administrative region;
2. drugs found in previous spot checks to fail to meet the requirements;
3. drugs which are found to have certain flaws through regular supervision;
4. drugs on which more adverse reaction reports are submitted;
5. drugs which receive rather more complaints and reports and attract high public sentiments;
6. drugs which require higher clinical dosage and have wider range of application;
7. drugs of which quality standards change materially;
8. drugs which have strict storage requirements and short period of validity, and of which active ingredients are prone to vary;
9. drugs which are newly approved to be registered and put on production; and
10.
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