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НАВЕРХ

Execution for Counterfeit

19 may 2017 12:26

In China deception of data on clinical trials will now be punished with imprisonment or death sentences. Until recently, in China only production of drugs not approved by the corresponding institutions and their production were considered to be a crime. Now the law has become more stringent. That interpretation of norms has been approved by the judicial committee and will soon come into effect, after publication by the Supreme Court.

That approach is explained by results of investigation which revealed, that in China in four of five cases clinical trials of new drugs were conducted with violations or were not conducted at all. At the end of last year a scandal was caused as a criminal group was disclosed, which bought drugs from unlicensed suppliers and sold them at a high price to illegal distributors and even (!) regional disease control centers. It also turned out that most of studies were performed inappropriately, lacked some important data or were not conducted at all. Official position was abused at all levels of the clinical trial system. Pressure was put on honest researchers, exceptionally positive results were demanded. Hence today there are concerns that the currently marketed drugs are not inspected or have passed inspection in disregard of regulations.

The 2015 report by the Chinese Food and Drug Administration (CFDA) specified the need to review the attitude to analysis of study results. It also stated that if any company is caught in a fraud, it shall no longer be entitled to submit drugs for approval. That statement yielded a staggering result: over 80 per cent of applications submitted by then were voluntarily recalled by the companies. The others were recalled by the agency due to suspicions over Признание равнозначности текста или содержания документа другому тексту, составленному на другом языке и имеющий одинаковую с ним силу.authenticity of studies.

The need for putting things in order in the pharmaceutical industry at the state level is now apparent. Approaches and interpretations of the law have been reviewed towards stricter norms.

Drug researchers, sponsors of clinical trials, leading investigators and healthcare professionals now know that China is not taking study results very seriously and falsifications will be strictly punished. If an approved drug damages somebody’s health, the manufacturer may go to prison for ten years or be sentenced to death. But even if the drug has not come to production and use, i.e. it has not harmed anyone yet, still those found responsible will be punished for falsification of clinical trials. A gap in the Chinese legislation has been filled. Falsification of data on studies of new drugs will entail criminal liability.

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