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    Home > Medical News > Medical World News > Severely punish the counterfeiting of application materials for the registration of pharmaceutical and medical devices

    Severely punish the counterfeiting of application materials for the registration of pharmaceutical and medical devices

    • Last Update: 2021-02-07
    • Source: Internet
    • Author: User
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    The Supreme People's Court and the Supreme People's Procuratorate issued on the 14th "Explanations on Certain Questions of the Law Applying to Criminal Cases of Counterfeiting of Application Materials for Registration of Drugs and Medical Devices", aiming to punish criminal acts of counterfeiting of application materials for registration of drugs and medical devices in accordance with the law and safeguard the rights and interests of the people in life and health.
    According to the judicial interpretation issued this time, if a staff member of a drug non-clinical research institution, a drug clinical trial institution or a contract research organization intentionally provides false drug non-clinical research reports, drug clinical trial reports and related materials, he shall be deemed to have "intentionally provided false supporting documents" as stipulated in Article 229 of the Criminal Law.
    At the same time, the judicial interpretation clearly stipulates that the intentional use of false experimental drugs in the course of non-clinical research of drugs or clinical trials of drugs, the concealment of serious adverse events related to drugs used in drug clinical trials, and the intentional destruction of raw drug non-clinical research data or drug clinical trial data shall be deemed to be "serious circumstances" as stipulated in Article 229 of the Criminal Law, so as to provide false supporting documents for a crime punishable by fixed-term imprisonment of not more than five years or criminal detention, and a fine.
    this judicial interpretation will take effect on 1 September 2017. (Xinhua) --
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