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| The heaviest punishment! Since September, medical registration has been registered for fraud |
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| Author：中国铭铉 企划部 Release Time：2017-8-15 11:15:50 Number Browse：953 |
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Medical network - August 15, August 14, the supreme people's court, the supreme people's procuratorate about drugs, medical devices registration application materials fraud criminal case to explain some issues of applicable law formally announced, and effective as of September 1, 2017.
On the basis of the judicial interpretation, in the medical device registration, deliberately provides medical device clinical trials, using a false report and related materials, will be to "deliberately provides false documents" sin or production and distribution of counterfeit drugs are "sin" convicted and punished.
Among them, "intentionally providing false proof of document crime", depending on the circumstances, the maximum sentence can be 10 years; "Whoever produces and sells counterfeit drugs", according to the criminal law, shall be sentenced to more than 10 years, life or even death penalty if the circumstances are particularly serious.
In addition, the new judicial interpretation provisions, staff members of state organs abuse of power or dereliction of duty, lead to using a false proof of medical device registration, will be to "the crime of abuse of power" or "the crime of dereliction of duty" shall be investigated for punishment.
The two high hands to the clinical trial of the direct sentence, is undoubtedly the heaviest punishment, its deterrent force also far exceeds the administrative penalty of the drug administration.
In 2016, is a drug safety for medical device clinical trials "first", to "strong-arm reaction the CFDA extract 20 companies for 20 registration items, the result authenticity problems in nearly half of all, there are a large number of enterprises take the initiative to withdraw the application for registration, caused strong repercussions in the industry.
In 2017, the drug administration will check the "re-sparing sword" for the clinical testing of medical devices, and the work is under way.
Last month, the CFDA launched a nationwide clinical trial monitoring of medical devices for 2017, and the first batch of 10 list of selected registered items has been released.
At the local level, hunan and fujian provincial drug administration have also launched their own clinical trial verification of medical products. The scope of the inspection in fujian province includes retrospective examination of the licensed products, once the data is detected, the registration certificate is revoked, and the relevant enterprises are not accepted for five years.
It is not clear which companies will be fined for alleged clinical trials this year.
Just catch at this juncture, projects promulgated the new judicial interpretation, clear, including clinical trial data for medical device registration material fraud penalties will be investigated, and how clear. This adds a particularly heavy deterrent to the verification of the clinical trials of medical devices in 2017.
Regulation is becoming more and more severe, and the punishment is getting heavier and heavier.
The attachment
The supreme people's court, the supreme people's procuratorate's interpretation of several issues concerning the application of the law for the application of the registration of materials for drug and medical devices
(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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