In China will be executed for the forgery of clinical trials of medicines
In accordance with the new interpretation of criminal law in China for counterfeiting on the clinical trial data will be put in jail or, in extreme cases, impose the death penalty. This was reported on the website of the publishing house Nature.
Tougher penalties became one of the measures which are taken in China to accelerate the approval of new drugs and not put on the market the dangerous and ineffective drugs. It is “at the moment the strongest signal to developers of medicines, organizers of clinical trials, leading researchers and doctors about the fact that China is very serious about test data,” said Dan Zhang, CEO of Fountain Medical Development, helps to organize research.
At this level the problem of data tampering speaking after the report’s release, the Chinese administration for quality supervision food and drug administration (CFDA) for the year 2015. In this office urged to reconsider the attitude to the accounting of test results and informed that if after this warning any company is convicted of forgery, she will no longer be able to provide medicines for approval.
After that, more than 80% submitted at the time the applications were withdrawn by companies. A quarter of the remaining declined the office because of problems with test data.
Under the new rules, if approved, the drug caused harm, the manufacturer can receive a prison term of ten years or a death sentence.
However, even if the production and application of medicine is not reached, convicted of forgery faces imprisonment of up to three years. However, it is unclear what an employee of the pharmaceutical company will be punished.
Previously, the offense was only manufacturing and selling unapproved drugs, but the falsification of data about the trials remained unresolved sphere. A new interpretation of the rules was approved by the judicial Committee on 10 April and will come into force after publication by the Supreme court in the coming months.
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