MediPharma committed
violations in 123 clinical
trials, including falsifying
blood pressure values,
something that has happened throughout the
organization since its founding.
The Ministry of Health, Labor and Welfare announced on the 17th that Medipharma (Tokyo), a clinical trial support company, had committed violations of the Pharmaceutical and Medical Devices Act (Pharmaceutical and Medical Devices Act), including falsifying data, in 123 clinical trials . assigned by the medical institution is announced. This includes clinical trials for a total of 25 approved drugs and medical devices. The Ministry of Health, Labor and Welfare believes that the company has committed repeated violations over the 10 years since its founding, and is considering disciplinary action.
According to the Ministry of Health, Labor and Welfare, data from clinical trials to ensure the effectiveness and safety of new drugs were falsified, including trial participants' blood pressure values and the timing of drug administration and blood sampling. Additionally, he shared passwords for viewing clinical trial data, which had to be managed separately, with doctors at medical institutions, and failed to report to pharmaceutical companies that he failed to maintain temperature controls for drugs used in clinical trials. Employees participate on their behalf in courses that medical professionals must take in order to properly conduct clinical trials.
After receiving the information, the Ministry of Health, Labor and Welfare conducted field inspections of the company three times between August 29 and September 4, and confirmed violations. The government plans not to withdraw approval of 25 products it has approved for production and sale, saying that even if falsified data is removed, their efficacy and safety can be confirmed.
There are no reports of health damage at this time.
Procedures for clinical trials are strictly determined by ministerial regulations regulated in the Pharmaceutical and Medical Devices Law. The company appears to be prioritizing streamlining its operations and ignoring necessary steps. It is possible that medical institutions were also involved in the violations, and we will continue the investigation. An official from the Ministry of Health, Labor and Welfare said, ``This is an unprecedented and extremely evil act.''
In an interview with the Yomiuri Shimbun, a Medipharma representative said, ``As a company, we have a problem. We deeply apologize to everyone involved. We will continue to reform our internal systems and work to restore trust."