Clinical
trial data recently, China Food and Drug Administration announced that
eight pharmaceutical companies 11 drug applications for registration
untrue, incomplete, decided not to approve its application for
registration, five institutions involved in clinical trials are the top
three public hospitals, to initiate an investigation.
You
should see, the State Food and Drug Administration on July 22 this
year, released the so-called "history of the most stringent data
verification requirements of" Notice (No. 117 text), requiring
pharmaceutical companies to self-examination, otherwise the discovery
data fraud will be severely dealt with in its verification, . After
more than a month, self-examination results were out, the original
number received in 1622, pharmaceutical companies guilty withdraw 20% of
the registration application. 11 test data found fake drugs now, you should belong to their own
situation did not withdraw the application and approval procedures are
found in the.
Clinical
trials of drugs, is a prerequisite for the approval of new drugs,
millions of people related to drug safety, but also a sacred cause. Now
he was exposed pharmaceutical companies and clinical trials hospital
collusion, a large area of the phenomenon of false test data, in
particular should have "life-saving for the bounden duty," the top three
public hospitals, will also participate in fraud, which is the
"intentional homicide" Yi? If you miss the patients' lives, "who bear its responsibility? No wonder netizens feel both "before the fear of" also "scared." "Before
the fear" that in the end how many such substandard drugs has flowed
into society, many people's physical and mental harm and life; "scared"
is relevant to investigate the breadth, depth and intensity, can be
completely into the community The channel cut off it?
Clinical trial data fraud so serious, is not suddenly emerge as a new disease. State
Food and Drug Administration who had admitted that "drug approval
clinical data fraud is already an open secret in the industry, not an
isolated phenomenon, but rather a common phenomenon," period "from 2007
to 2008, and then every two or three years, the State Food Drug Administration have focused on consolidation, but so far, the
chaos has not been effectively curbed, "a serious problem to the extent
evident.
Investigate clinical trials data fraud, not without national legal basis. "Drug
Administration Law" stipulates that drug manufacturers, drug clinical
trial institution is not in accordance with the implementation of Good
Clinical Practice (GCP), and given a warning and ordered to make
corrections; overdue correction shall be ordered to stop production,
suspend business for rectification, and impose a five thousand yuan to 20,000 yuan fine; circumstances are serious, revoked "drug
production license" and drug clinical trial institution qualification.
The
competent authorities in accordance with the argument, long-standing
problem, logically there should be some units that investigate
announcements and warnings, but in public information due to clinical
trial data fraud investigation by pharmaceutical companies, almost one
case related to hospitals are not retrieved. The
Food and Drug Administration hospital system than someone direct filing, indeed quite obviously determined: Only when this "thorough
investigation to punish" has become the norm, the probability of illegal
promotion by the investigation, which had itself the only hazard fraud You will be curbed.
From
this investigation pharmaceutical companies and public hospitals, the
administrations ability to identify problems, no doubt. But
now, the relevant sanctions does not match the extent of its bad
behavior: pharmaceutical companies currently involved in clinical trials
for fraud data, clinical trials institutions, contract research
organizations and their direct responsibility, the punishment is
blacklisted, and to Social publish relevant organization code, identity card numbers and
other personnel, suspected of a crime, the transfer of public security
organs investigation.
But
taking into account this "blacklist" just inside outward publish some
of the "code" and "number" are not really even punishment (is not
punishment species), which from the public expected "punish" Obviously
there is distance. 117
paper, "the most stringent standards, the most stringent regulation,
the most severe punishment, the most serious accountability", the legal
aspects of the "bell" is the basic premise, which include administrative
accountability. Even if the administrative responsibility could not see, so-called transfer of suspected criminal justice, is the feint.
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