Medical network on April 12 - TV "in the name of the people" is popular, the people's procuratorate anti-corruption department cadres Hou Liangping Zhong Xiaoyi dialogue with his wife ponder. 

 

Hou Liangping: the damage to the people and the country of corruption, finally going to country and people pain dissipates. 

 

Zhong Xiaoyi: because the party's anti-corruption efforts, and our department of anti-corruption struggle of sacrifice, the damage will be stopped after all. 

 

Hou Liangping: pain is inevitable,... We put a corrupt officials were arrested, bring them to justice in the name of the people, but those corrupt officials brings to the national image and damage to the pain of the people, must be borne by the long years to go. 

 

Zhong Xiaoyi: scraping the bone healing poison is takes a lot of courage. 

 

Hou Liangping: people will always remember that the process of the rise of the country experienced how painful scraping the bone healing, and how many a strong man DuanWan? 

 

We might as well put the dialogue in the "corruption" to replace "drug registration data fraud" behavior, every pharmaceutical research participants to check against your own work, whether in the name of "the people" to ensure the quality of the drug safety effectively. 

 

At yesterday, the chief justice, President of the supreme people's court, zhou qiang chaired a meeting of the supreme people's court trial committee plenary meeting, review and principles through the supreme people's court, the supreme people's procuratorate about drugs, medical devices registration data fraud criminal cases to explain some issues of applicable law (hereinafter referred to as the "explanation"). 

 

The supreme people's court of the People's Republic of China on April 10, 2017 20:09:43 released the same day approval "explanation", combining with the state food and drug supervision and management of the administration of the recently released five draft, research and development work for data authenticity supervision reached unprecedented heights. 

 

Extension file: 

 

 

 

For drugs, medical devices registration data frauds seriously affect the drug quality safety and drug regulatory authority, endanger people's health and life security, the social from all walks of life reflect strong. The CPC central committee attaches great importance to drug safety supervision work, made important instructions for many times, with the most rigorous standards, strict regulation, the most severe punishment, the most serious accountability, strict with every line of defense from the lab to the hospital. 

 

For the implementation of the deployment of the CPC central committee, in accordance with the law to punish drug, medical device registration data fraud in the process of illegal and criminal behavior, to ensure the safety of medicines, medical apparatus and instruments, safeguard the people's life and health rights, since July 2016, the supreme people's court to start drafting the "explanation". 

 

After in-depth research, respectively specialized GaiGaoHui, symposium, expert discussion meeting, and invite the supreme people's procuratorate, ministry of public security and administration of state food and drug supervision and administration of relevant personnel, to provide detailed research and discussion, modifications to explain. To solicit legislative authority, the central authorities, part of the higher people's court and its related YeWuTing, modify SongShenGao formation, submitted to the conference. 

 

Over the past 20 years, our country through the GMP production management and post-marketing sampling was carried out on the drug administration of quality supervision, but drugs is not the quality of the inspection, also is not produced, but developed, drug quality from design, proved the safety of the drug efficacy, must rely on randomized, double-blind, clinical trials of large sample; Between drug post-marketing batch consistency of quality, must depend on the research and development stage of adequate and reliable pharmaceutical research. Today, in April 2017, in the process of drug registration data authenticity finally on the height of penal responsibility, the four "most" instructions at the origin of life of drugs in the lab, it is not too late to everything. 

 

"Explain" SongShenGao regulation, drug non-clinical research institutions, drug or medical device clinical test units, contract research organization deliberately provides false non-clinical study, clinical test report, can be convicted and punished by providing false documents sin -- 

 

Article 2015 of the criminal law of the People's Republic of China (2015 revision) : 

 

[providing false documents; major false certification documents issued by sin 】 for asset appraisal, capital verification, validation, accounting, auditing, legal services, such as responsibility of intermediary organization staff deliberately provides false supporting documents, if the circumstances are serious, shall be sentenced to fixed-term imprisonment of not more than five years or criminal detention and fine. 

 

The provisions of the preceding paragraph, extort property from others property or illegally accept others commits the crime, shall be sentenced to imprisonment of not more than five years but not more than ten years, fine. 

 

The first paragraph of the personnel, serious irresponsible, the certification documents issued by a major untrue, thereby causing serious consequences, shall be sentenced to fixed-term imprisonment of not more than three years or criminal detention, and concurrently or independently be sentenced to a fine. 

 

Drug non-clinical research institutions, drug or medical device clinical trial institution, contract research organization, with the drug registration applicant provides false non-clinical research or clinical test report and related materials, diddle drug approval documents, at the same time, make crime of providing false documents and production, sales, the crime of counterfeit, convicted and punished for heavier punishment crime. 

 

Jude remember 2015, total bureau of national food and drug supervision and administration of drug clinical trial data check list at the beginning of the inspections (" 722 "to check the storm), CRO in the institutions of the media claim to be asked to fraud and is forced to fake, but the scene of a fraud. Collusion fraud is a shame in the drug research and development history of China. Drug registration the applicant is the first responsible of drugs, the problem will eventually bring the applicant for drug registration project failure, loss of funds, risk of penalties, manage drug non-clinical research institutions, drug or medical device clinical test units, contract research organization development, and to respect and accept the real drug research and development results are very important. 

 

The meeting after the discussion, principles through the "explanation". Meeting, according to the meeting to discuss Suggestions to modify "explain" SongShenGao and countersign and timely release of the supreme people's procuratorate.