Manufacturing problems at Mitsubishi Tanabe Pharma (MTP) have forced CEO Michihiro Tsuchiya to relinquish his vice presidency of the Japanese Pharmaceutical Manufacturers Association (JPMA).
According to Kyodo News International Tsuchiya was pressured to leave the post after Japan’s drug regulators, the Ministry of Health Labour and Welfare (MHLW), imposed a 25-day manufacturing ban on MTP earlier this month.
The injunction is based on the discovery that data submitted to support approval of MTP’s Medway Injection 5% and 25% recombinant human serum albumin products were “based on fraudulent acts” committed by its subsidiary Bipha.
An unnamed MHLW official told the Mainichi Daily News that: "Bipha was engaged in systematic misconduct in its quality control and production processes, while Mitsubishi Tanabe Pharma overlooked such improper practices irresponsibly."
The MHLW action requires that both MTP and Bipha, which was also ordered to suspend manufacturing operations, submit corrective business improvement plans to the regulators.
In its response the manufacturing ban, MTP apologised to patients and physicians and stressed that it has already withdrawn marketing authorisation and recalled both of the affected products.
The Osaka firm added it “will work to prevent a recurrence [of the issue] by reemphasizing the importance of strictly observing GMP, ensuring the reliability of materials used in support of applications and ensuring rigourus compliance with other pharmaceutical related regulations.”
And, while the drugmaker did not respond to in-Pharmatechnologist’s request for additional specific information, various media reports suggest it has set up a “Medway Issue Countermeasures Committee” to further address the matter.