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| Two high release: the medical person violates these regulations will be sentenced! |
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| Author：中國銘鉉 企劃部 Release Time：2017-8-15 11:12:51 Number Browse：627 |
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On August 15, the medical website "two high" messages: from September 1, clinical data falsification will be sentenced!
Yesterday (August 14), the supreme people's court, the supreme people's court of the supreme people's procuratorate about drugs, medical devices registration application materials fraud criminal cases to explain some issues of applicable law (hereinafter referred to as the "explanation"), and effective as of September 1, 2017 formally, drugs, medical devices registration material fraud.
▍ projects release: six behavior was identified as "serious"
According to the "projects" issued by the latest "explain" : "pharmaceutical non-clinical research institutions, and the drug clinical trial institution, contract research organization staff, deliberately provides false drug clinical trials, drug non-clinical study report and related materials, for the criminal law article two hundred and twenty-nine of this law shall be deemed as" deliberately provides false documents ".
The following six behavior was identified as "serious" prescribed in article two hundred and twenty-nine of the criminal law, by providing false documents crimes shall be sentenced to fixed-term imprisonment of not more than five years or criminal detention, fine, including:
(1) deliberately use false test drugs in non-clinical studies or in clinical trials of drugs;
(2) to conceal serious adverse events related to drugs in clinical trials of drugs;
(3) deliberately damaging the data of non-clinical research data or drug clinical trial data of the original drug;
(4) information in animals, the participants information records, research data, the main test process, test data for pharmaceutical non-clinical research and the data or drug clinical trial data, affect drug safety, efficacy evaluation results;
(5) having been subject to criminal punishment for providing false proof materials in the registration of drugs or medical devices, or having received administrative penalties in two years, and providing false supporting materials;
(6) other serious circumstances.
▍ constraint "counterparts"
In addition to the explicit constraints of enterprises and clinical institutions, this paper also provides a special disciplinary measure for "corresponding party" :
Article 2 the implementation of the provisions of this explain the first behavior, ask for or illegally accepts another person's property, shall be in accordance with the provisions of the second paragraph of article two hundred and twenty-nine of the criminal law, by providing false documents in sin more than five years shall be sentenced to fixed-term imprisonment of not less than 10 years, fine; In the meantime, the crime of providing false supporting documents and the crime of accepting bribes or accepting bribes shall be punished in accordance with the provisions of the heavier punishment.
Article 3 for drug registration unit staff, deliberately used in this explanation in paragraph 2 of article 1 of the false drug clinical trials, drug non-clinical study report and related materials, diddle drug approval document production, sales, pharmaceutical, shall be in accordance with the provisions of article one hundred and forty-one of the criminal law, to production, the sale of counterfeit drugs crime convicted and punished.
Article 4 for drug registration unit staff instructed drug non-clinical research institutions, drug clinical trial institution, contract research organization staff to provide the explanation in paragraph 2 of article 1 of the false drug clinical trials, drug non-clinical study report and related materials, to provide false documents crimes will be punished as a joint crime.
In case of any of the following circumstances, it may be deemed to be "directed" as provided for in the preceding paragraph, except for the contrary evidence:
(1) if the relevant institutions and organizations do not have the corresponding conditions or abilities, they shall still entrust them to conduct drug non-clinical studies and clinical trials of drugs;
(2) the payment price is significantly different from the normal cost.
For drug registration unit staff and drug non-clinical research institutions, drug clinical trial institution, contract research organization staff to the behavior of the implementation of the first paragraph, diddle drug approval document production, sales, pharmaceutical, at the same time, make crime of providing false documents and production, sales, the crime of counterfeit, shall be convicted and punished in accordance with of the heavier punishment.
For drugs, medical devices registration the functionary of a state organ responsible for the verification, abuse of power or dereliction of duty, lead to using a false proof of medicines, medical apparatus and instruments for registration, and cause public property, country and people interest to suffer heavy losses, shall be in accordance with the provisions of article three hundred and ninety-seven of the criminal law, crime of abuse of power or dereliction of duty shall be investigated for criminal responsibility according to law.
"Explain", meanwhile, to ask for or illegally accept property of others also puts forward the specific penalty - in accordance with the provisions of the second paragraph of article two hundred and twenty-nine of the criminal law, by providing false documents sin above shall be sentenced to fixed-term imprisonment of not more than ten years of not more than five years, fine; In the meantime, the crime of providing false supporting documents and the crime of accepting bribes or accepting bribes shall be punished in accordance with the provisions of the heavier punishment.
▍ remedies: governing revolution registration data storm again!
"There is a serious problem in drug clinical trials, and it is very common to have irregularities and incomplete problems." Wu zhen, deputy director of the state administration of food and drug administration, pointed out at a meeting of the clinical data self-inspection in July 2015.
Publicly reported, according to a July 22, 2015, national food drug safety administration issued "about a drug clinical trial data comprehensive inspections of announcement no. 117 (2015), after the drugs industry immediately caused wild swings, many drug firms self-induction clinical trial application difficult pass, offered to withdraw the application.
As of September 28, 2016, according to the state food and drug supervision bureau's website published in 2016 no. 21, no. 45, no. 81, no. 92, no. 109 announcement data, because of clinical trial data is not true, such problems as incomplete, national food drug safety administration of China shall not be approved, drug companies check list apply for withdrawal of the drug registration application as high as 1308, accounting for 80.6% of the required inspection check total 1622.
After deducting 165 non-clinical trial drugs, the proportion reached 89.8%, nearly 90%, and several well-known listed drug companies ranked among them.
After that, the verification scope to further expand - July 10 this year, total bureau of national drug safety alerts, organized in the clinical trial data for medical device registration authenticity, compliance to supervise and inspect, investigate clinical trials violation behavior, and the supervision and inspection and processing results to the public.
In order to solve the problems of drugs and medical devices in clinical trials, the state departments of relevant departments have been more and more heavily involved in the efforts to improve the treatment of drugs and medical devices.
The highest method for drugs, medical devices registration problem explained clear, further regulate the industry, standardize further refinement, once more put forward a crime, be given a heavier punishment, no doubt increased the deterrence of the industry.
A bigger and more violent data monitoring storm!
The attached:
Legal release [2017] no. 15
The supreme people's court, the supreme people's procuratorate
Criminal cases concerning the registration of materials for the registration of drugs and medical devices
Interpretation of several issues of applicable law
(April 10, 2017, the supreme people's court trial committee, June 8, 2017, the 1714th meeting of the supreme people's procuratorate the 12th 65th meeting by the procuratorial committee, shall be implemented as of September 1, 2017)
For punishment in accordance with the pharmaceutical, medical device registration application materials of fraud crime, protecting the life and health rights and interests of the people, according to the law of the People's Republic of China criminal law "the relevant provisions of the" criminal procedure law of the People's Republic of China, now has to deal with this kind of criminal cases on several issues of applicable law explanation is as follows:
The first drug non-clinical research institutions, drug clinical trial institution, contract research organization staff, deliberately provides false drug non-clinical study for pharmaceutical clinical test report and related materials, for the criminal law article two hundred and twenty-nine of this law shall be deemed as "deliberately provides false documents".
Implementation of the provisions of the preceding paragraph, has one of the following circumstances, shall be deemed to be "serious" prescribed in article two hundred and twenty-nine of the criminal law, to provide false documents crimes shall be sentenced to fixed-term imprisonment of not more than five years or criminal detention and fine:
(1) deliberately use false test drugs in non-clinical studies or in clinical trials of drugs;
(2) to conceal serious adverse events related to drugs in clinical trials of drugs;
(3) deliberately damaging the data of non-clinical research data or drug clinical trial data of the original drug;
(4) information in animals, the participants information records, research data, the main test process, test data for pharmaceutical non-clinical research and the data or drug clinical trial data, affect drug safety, efficacy evaluation results;
(5) having been subject to criminal punishment for providing false proof materials in the registration of drugs or medical devices, or having received administrative penalties in two years, and providing false supporting materials;
(6) other serious circumstances.
Article 2 the implementation of the provisions of this explain the first behavior, ask for or illegally accepts another person's property, shall be in accordance with the provisions of the second paragraph of article two hundred and twenty-nine of the criminal law, by providing false documents in sin more than five years shall be sentenced to fixed-term imprisonment of not less than 10 years, fine; In the meantime, the crime of providing false supporting documents and the crime of accepting bribes or accepting bribes shall be punished in accordance with the provisions of the heavier punishment.
Article 3 for drug registration unit staff, deliberately used in this explanation in paragraph 2 of article 1 of the false drug clinical trials, drug non-clinical study report and related materials, diddle drug approval document production, sales, pharmaceutical, shall be in accordance with the provisions of article one hundred and forty-one of the criminal law, to production, the sale of counterfeit drugs crime convicted and punished.
Article 4 for drug registration unit staff instructed drug non-clinical research institutions, drug clinical trial institution, contract research organization staff to provide the explanation in paragraph 2 of article 1 of the false drug clinical trials, drug non-clinical study report and related materials, to provide false documents crimes will be punished as a joint crime.
In case of any of the following circumstances, it may be deemed to be "directed" as provided for in the preceding paragraph, except for the contrary evidence:
(1) if the relevant institutions and organizations do not have the corresponding conditions or abilities, they shall still entrust them to conduct drug non-clinical studies and clinical trials of drugs;
(2) the payment price is significantly different from the normal cost.
For drug registration unit staff and drug non-clinical research institutions, drug clinical trial institution, contract research organization staff to the behavior of the implementation of the first paragraph, diddle drug approval document production, sales, pharmaceutical, at the same time, make crime of providing false documents and production, sales, the crime of counterfeit, shall be convicted and punished in accordance with of the heavier punishment.
Article 5. In the application for registration of medical devices, the purpose of providing and using false medical device clinical trial reports and related materials shall be provided in accordance with the provisions of article 1 to 4 of this interpretation.
Article 6 units made the explanation, the crimes specified in article 5 of the first to fined unit, and interpreted in accordance with the provisions of the relevant natural person crime standard criterions for the conviction of the person in charge directly responsible and other directly responsible personnel shall be decided a crime and punished.
Article 7 for drugs and medical devices registration the functionary of a state organ responsible for the verification, abuse of power or dereliction of duty, lead to using a false proof of medicines, medical apparatus and instruments for registration, and cause public property, country and people interest to suffer heavy losses, shall be in accordance with the provisions of article three hundred and ninety-seven of the criminal law, the crime of abuse of power or dereliction of duty shall be investigated for criminal responsibility according to law.
Article 8 whether to belong to the false drug non-clinical study, drug or medical device clinical test report and related materials, whether affect the drug or medical device safety and efficacy evaluation result, and whether it belongs to the special problems such as serious adverse events are difficult to determine, can be set according to the national pharmaceutical supervisory and administrative department or the specified drugs, medical apparatus and instruments issued by institutions such as the review opinions, in combination with other evidence to make.
Article 9 "contract research organization" mentioned in the present interpretation, refers to the drug or medical device registration application units, drug non-clinical research institutions, drug or medical device clinical trial institution, engaged in testing scheme design, data statistics, analysis, testing, monitoring, inspection and the clinical research or clinical trial related activities of the unit.
Article 10 this explanation shall come into force as of September 1, 2017.
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