Regarding medicine、Medical Device Registration Application Application Materials Criminal Criminal Case Explanation of Criminal Cases (full text)

"Supreme People's Court、Supreme People's Procuratorate on handling medicines、The Explanation of Several Issues of Criminal Cases of Medical Device Registration Application Materials. "、June 8, 2017 was approved by the 65th meeting of the 12th Procuratorate of the Supreme People's Procuratorate,Now announced,From September 1, 2017。

Supreme People's Court Supreme People's Procuratorate

August 14, 2017



Supreme People's Court Supreme People's Procuratorate on handling medicines、Medical Device Registration Application Application Materials Criminal Criminal Case Applicable Law Explanation

Fa Shi [2017] No. 15


(April 10, 2017, the 1714th meeting of the Supreme People's Court Judgment Committee、June 8, 2017 The 65th meeting of the 12th Procuratorate of the Supreme People's Procuratorate approved,It will be implemented from September 1, 2017) 



Stake Sports BettingPunish medicines for law、Criminal behavior of counterfeiting application materials for medical device registration,Maintaining the health rights and interests of the people of the people,​​According to the relevant provisions of the Criminal Law of the People's Republic of China and the Criminal Procedure Law of the People's Republic of China,Several issues of applicable laws to apply for such criminal cases are explained as follows: 

The first drug non -clinical research institution、Drug Clinical Test Institution、Staff of contract research organization,Intentional providing false drug non -clinical research reports、Drug Clinical Test Report and related materials,shall be identified as "intentional provision of false certification documents" specified in Article 229 of the Criminal Law。

Exercise stipulated in the preceding paragraph,With one of the following circumstances,It shall be identified as "serious plot" specified in Article 229 of the Criminal Law,To provide false certification documents for less than five years in prison or detention,Power of fines: 

(1) Drugs that deliberately used false tests during drug non -clinical research or drug clinical trials; 

(2) Concerning serious adverse events related to drug clinical trials; 

(3) deliberately damaged the non -clinical research data or drug clinical trial data of the original drug; 

(4) Formulating test animal information、Subject information、Main test process records、Research Data、Test data such as non -clinical research data or drug clinical trial data,Affecting drug safety、Effective evaluation results; 

(5) Because of applying for medicines、During the registration of medical device registration, providing false certification materials is punished by criminal punishment or administrative punishment within two years,providing false certification materials; 

(6) serious situations stake betting appof other circumstances.

Article 2 Implementation of the behavior specified in Article 1,Cangle or illegally accepts the property of others,It shall be in accordance with Article 229 of the Criminal Law,To provide false certification documents for more than five years and less than ten years in prison,Published; at the same time, it constitutes the crime of providing false certification documents and the crime of bribery、The crime of bribery for non -state staff,Conflicia and punishment in accordance with the heavy punishment。

Article 3 Staff of the drug registration application unit,Delicate uses the non -clinical research report of false drugs stipulated in paragraph 1 of this interpretation、Drug Clinical Test Report and related materials,Checking drug approval document production、Selling medicine,It shall be in accordance with Article 141 of the Criminal Law,Production、Concerning punishment for selling fake drugs。

Article 4 The staff of the drug registration application unit instructed the drug non -clinical research institution、Drug Clinical Test Institution、The staff of the Contract Research Organization provides a non -clinical research report stipulated in Article 1 (22、Drug Clinical Test Report and related materials,Common crime theory of providing false certification documents。

One of the following situations,It can be identified as "instruction" specified in the preceding paragraph,but except for the opposite evidence: 

(1) Know the relevant agency、Organization does not have corresponding conditions or abilities,Still commissioned it to conduct drug non -clinical research、Drug clinical trials; 

(2) The price paid is obviously different from normal expenses.

Pharmaceutical registration application unit staff and drug non -clinical research institution、Drug Clinical Test Institution、The staff of the Contract Research Organization shall jointly implement the behavior specified in the first paragraph,Checking drug approval document production、Sales My stake betting appdrugs,At the same time, it constitutes the crime of providing false certification documents and production、The crime of selling fake drugs,Conflicia and punishment in accordance with the heavy punishment。

Fifth in the application for registration of medical device,deliberately provided、Use false medical device clinical trial reports and related materials,Refer to the provisions of Article 1 to 4 of this explanation。

Article 6 Units offending the crime stipulated in Article 1 to 5,Funding for the unit,And the conviction standard for crime of crime of natural person crimes in accordance with the provisions of this interpretation provides convicted punishment for direct responsible persons and other directly responsible persons。

Seventh to medicine、Medical Device Registration Application Application for Staff of State organs with responsibilities,Abuse of power or neglects the job,Drugs that cause false certification materials、Registration of medical devices,To public property、The interests of the country and the people suffer from major losses,It shall be in accordance with Article 397 of the Criminal Law,Criminal liability for abuse of power or neglecting the crime。

Article 8 of the non -clinical research report for whether it is false drugs、Drug or medical device clinical trial report and related materials,Whether it affects drugs or medical equipment safety、Effective evaluation results,and whether it is a serious adverse event and other specialized issues that are difficult to determine,It can be set or specified according to the national drug supervision and management department、Opinions issued by institutions such as medical device review,Make determination with other evidence。

1 The "Contract Research Organization" mentioned in this explanation,refers to the application unit of drug or medical device registration、Drug non -clinical research institutions、Drug or medical device clinical trial agency stake sports betting appcommission,Engaged in the test plan design、Data statistics、Analysis test、Inspection and audit, units related to non -clinical research or clinical trials。

Article 10 This explanation will be implemented from September 1, 2017。

A secretary of the General Office of the Supreme People's Court

issued on August 14, 2017