August 15，The General Administration of Drug Administration released the "Implementation Opinions on the Construction of the Rule of Law of the Food and Drug Supervision System"，Among them, two information is for pharmaceutical companies，The relationship is great。One is to report to the State Council before the end of the year; the second is to introduce the judicial interpretation of clinical fraud punishment。

 

  How to revise the drug method?

 

  It is understood，The current "Drug Management Law" in my country was formally implemented in 1985，The first revision in 2001。

 

  But after more than 10 years of development，This version is also not suitable for the reform and development of the industry，Lack of relevant regulations for the new format of the industry，For example, in clinical self -examination，Determination of the responsibility of relevant units，There are still a lot of confusion。

 

  CFDA Deputy Director stake sports betting appJiao Hong revealed at the end of last year at the end of last year，The four basic principles of the amendments to the drug law are: problem -oriented; fully draw on the advanced experience of international supervision; consider Chinese drug management national conditions; take innovation as a driver。

 

  It can be seen from this，Solving real problems is the most important principle of revising the drug method。This also reminds us to think，Which is the current often problems、The punishment measures are not clear、The punishment is obviously not enough?

 

  March this year，CFDA's official media "China Medical News" has published a suggestion article on the modification of the drug method，Author Yang Yipei mentioned in the article，Pharmaceutical production、Business、Use & rdquo; Define from simple medicine production、Business、Use an enterprise/institution，Expand to drug production、Business、Use enterprise institutions and individuals，Applicable range expansion in large areas。At the same time，Including the release of drug advertisements、Drug price management、Drug Supervision Recall, etc.，Also adaptive objects will be expanded from the unit to the unit and individual。

 

  Clinical data fraud, you may have to go to jail

 

  In the above & ldquo; Opinions & rdquo; middle，CFDA said that it will actively cooperate with the Supreme People's Court、Supreme People's Procuratorate，Strive to introduce judicial interpretation of the clinical data of severe punishment drugs by the end of 2016。

 

  We know，Law even if it is complete，It is also difficult to avoid & ldquo; legal loopholes & rdquo; phenomenon。Under the circumstances where the law exists，Judicial interpretation has the effect of filling vulnerabilities。

 

  In the above judicial stake betting appinterpretation，We noticed that the official words were & ldquo; Drug clinical data fraud crimes & rdquo; judicial interpretation，14105_14138，refers to the behavior of violating my country's criminal law。The punishment of the crime includes control、Detention、Jests in prison、Dialogue imprisonment and death sentence。

 

  This, the problem is serious!

 

  According to the "Drug Management Law" regulations，Production enterprise of drugs、The drug clinical trial institution has not implemented the quality management specifications of drug clinical trials in accordance with regulations，Give warning，Order to correct correction within a time limit;，Order to stop production、Stop business and rectification，Paimant fined 5,000 yuan or less;，Flowing "Drug Production License" and the qualifications of the drug clinical trial institution。

 

  In the clinical self -examination related documents of the drug supervision department，Punishment measures for data fake behavior，It mainly includes the registration application will not be approved、Blacklist System、Survey of suspected crime、Qualification of revocation、Inquiring person in charge, etc.。

 

  From here，In the past，The target of clinical fraud punishment is mainly the institution，The strength of punishment does not look heavy enough，Penalties for individuals are also limited，Although there is a drug supervision department & ldquo; accountable person & rdquo; this punishment，But after all, it is just departmental rules，No reflection in the Drug Management Law。

 

  Drug Clinical Fake，is the first step for people's livelihood and health，Harmful harm。

 

  In the United States，2001，Aventis's listing new drug Talithromycin conducted severe data fraud in phase III clinical research after listing，Stake Sports BettingThe person in charge of the experiment was finally sentenced to 57 -month imprisonment，and was fined $ 557,000、Compensation 926,000 US dollars。

 

  2009，At that time, the clinical research of schering-ploughs in the company had data fraudulent behaviors，Two researchers suspected of clinical data fraud have been sentenced to 1 year of supervision。

 

  It can be expected，After the new judicial interpretation，Clinical fraud will be qualitatively crime，It may be in jail! Pharmaceutical company、Hospital、third -party service agency，Dare to counterfeit? Pharmaceutical companies carry out drug clinical experiments，Will the price rising again?

 

  By the way

 

  CFDA also plans to complete the "Explanation of Several Issues on Applying Laws to Criminal Criminal Cases in Food Safety" by the end of 2017，Increase the crackdown on food and drug crimes。

 

  Saibailan learned，"Interpretation of Several Issues of the Application of Laws for Criminal Cases Harmly Harm" is a judicial interpretation officially implemented in November 2014，Among the 8 provisions explained by the judicial interpretation，Just mentioning production、Various penalties for selling fake drugs，but did not involve punishment for the act of research and development and clinical fraud。

 

  According to the judicial interpretation，in production、Sales fake medicine，With one of the following circumstances，It should be punished as appropriate:

 

  1、Production、The fake drugs sold for pregnant women、Infant、Children or patients with crisis are the main use objects;

 

  2、Production、Fake drugs sold are anesthesia drugs、Psychiatric drugs、Medical toxic drugs、radioactive medicine、contraceptive drugs、Blood Products、Vaccine;

 

  3、Production、The fake drugs sold are injection My stake betting appdrugs、First aid medicine;

 

  4、Medical Institution、Production of staff members of medical institutions、Sell fake drugs;

 

  5、In the natural disaster、accident disaster、Public health incident、Social Security Incident and other emergencies，Production、Sales for fake drugs for emergencies;

 

  6、In the past two years, it was punished or criminal punishment for dangerous drug safety criminal activities;

 

  7. Other circumstances that should be punished as appropriate.