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Drugs and medical equipment clinical data fraud, at least three years in jail!

  • Author:Jane
  • Source:ZHIYAO
  • Release on :2017-04-13
According to public information, April 10, the Supreme People's Court Judicial Committee plenary meeting to consider and in principle through the "Supreme People's Court, the Supreme People's Procuratorate on the handling of drugs, medical equipment registration application data fraud criminal cases applicable to the interpretation of a number of issues" (below Referred to as "interpretation"), "interpretation" clear, for drug registration applicants themselves fraud, to provide false non-clinical research or clinical trial reports and related materials, fraudulent drug approval documents, according to the production and sale of fake drugs convicted and punished.

July 22, 2015, the State Food and Drug Administration set off a clinical trial self-check the storm, as of January 2016, the initiative to withdraw and not registered by the proportion of self-examination and check the total variety of 80%. In view of clinical trial self-examination and verification of the problems, the State Food and Drug Administration to severely punish intentional fraud. "Interpretation" of the introduction of counterfeiters, will undoubtedly play a great deterrent effect. According to reports, "interpretation" in July 2016 by the Supreme People's Court drafted, invited the Supreme People's Procuratorate, Ministry of Public Security and the State Food and Drug Administration of the relevant personnel, the interpretation of the draft by article to discuss and improve.

Three false acts will be found guilty

The "explanation" clearly states that the following three acts will be considered guilty:

1, drug non-clinical research institutions, drug or medical device clinical trial institutions, contract research organizations deliberately provide false non-clinical research report, clinical trial report, you can "provide false evidence" conviction and punishment;

2, for the drug registration of their own fraud, to provide false non-clinical research or clinical trial reports and related materials, fraudulent drug approval documents, can be "production and sale of fake drugs" conviction and punishment;

3, drug non-clinical research institutions, drug or medical device clinical trial institutions, contract research organizations and drug registration applicants conspiracy to provide false non-clinical research or clinical trial reports and related materials, fraudulent drug approval documents, "False proof document crime" and "production, sale of fake drugs" to punish heavier crimes convicted and punished.

Although the standard of sentencing has not yet been published, the Supreme People's Procuratorate has, in principle, adopted the "interpretation", which, according to media reports, will be issued by the highest seizure after being revised.

The above three kinds of fraud, how will sentenced it? Jianjun Jun inquired about the relevant provisions of the Criminal Law.

According to the "Criminal Law" shows that "the provision of false proof of the crime" at five years imprisonment or criminal detention, and fined. Production and sale of fake drugs: imprisonment for three years or criminal detention, and fined; serious harm to human health or other serious circumstances, at three years and ten years imprisonment, and fined; Or have other particularly serious circumstances, at more than 10 years in prison, life imprisonment or death, and fined or confiscated property.

Clinical data check storm recurrence?

Perhaps this is the continuation of clinical data to check the storm.

July 22, 2015, the State Drug Administration issued ("CFDA") "the State Food and Drug Administration on the drug clinical trial data self-verification work of the announcement (No. 117, 2015)", the document Listed 1622 acceptance number need to self-examination, and asked on August 25 this year, submitted to the electronic version of the report, or withdrawal of the application, the industry known as the "722 massacre."

After that, CFDA combat clinical data fraud showed a high pressure situation. As of January 2017, CFDA sent a total of 116 inspection teams, more than 900 people check, verify 203 varieties, spot checks more than 400 clinical trial institutions. CFDA Deputy Director Wu Zhen this highly affirmative, open to the media, said: "Through our verification, clinical trial data fraud situation has been significantly curbed."

Compared to 10,000 in 2014, more than 8000 pieces in 2015, 2016 China's drug registration to reduce the amount of less than 5,000 registered.

Wu Zhen stressed that in the future inspection work must maintain a high degree of vigilance to prevent the phenomenon of fraud comeback, adhere to the "one ruler in the end," must not be tight before the loose, the former strict width, and can not vary Different

The Supreme People's Court Judicial Committee passed the "interpretation" to improve the registration application data fraud laws and regulations, CFDA for the future management of clinical data verification to provide legal weapons, to create law enforcement conditions.

Two high "interpretation" of the introduction, is undoubtedly to further deter the industry and clinical testing institutions, clinical data fraud will not only face the drug supervision of the registration of administrative penalties, public security, prosecutors and the court will be timely intervention, Impose criminal penalties such as imprisonment and fines.