一般財団法人化学及血清療法研究所

The fact that Enceback subcutaneous injection was manufactured differently from the description in the manufacturing and marketing approval.

Manufacturing differed in some aspects from the contents of the manufacturing and marketing approval certificate.

The Ministry of Health, Labour and Welfare conducted a review of the reported information. Today, at the Infectious Disease Subcommittee of the Health Science Council, based on the attached materials, the results of the review by the Ministry (which concluded there are no discrepancies that would significantly affect quality and safety), and the inventory outlook for similar products from other companies were reported. Opinions were sought on whether to approve the shipment of Kaken Pharmaceutical's 'Enceback Injection' (dry cell culture Japanese encephalitis vaccine). As a result, it was received that, from the perspective of promoting the prevention and control of Japanese encephalitis, shipment should be permitted to avoid supply shortages. Based on these opinions, the Ministry of Health, Labour and Welfare has decided to lift the request for Kaken Pharmaceutical's 'Enceback Injection' (dry cell culture Japanese encephalitis vaccine) to refrain from shipment as of today.

Failure to properly report discrepancies between approval documents and manufacturing practices to the Ministry of Health, Labour and Welfare.

Reports to the Ministry of Health, Labour and Welfare regarding discrepancies between approval documents and manufacturing practices were not properly made.

Reports to the Ministry of Health, Labour and Welfare regarding discrepancies between approval documents and manufacturing practices were not properly made.

The Ministry of Health, Labour and Welfare has issued an administrative suspension order to the General Incorporated Foundation, Chemical and Serum Therapy Institute, based on Article 75, Paragraph 1 of the Pharmaceuticals and Medical Devices Act, for a period of 110 days from January 18, 2016 (Monday) to May 6, 2016 (Friday).

Reports to the Ministry of Health, Labour and Welfare were not properly made.

Failure to properly report discrepancies between approval documents and manufacturing practices to the Ministry of Health, Labour and Welfare.

It was found that for vaccines and related products manufactured and sold by Kasei Ken, appropriate reports had not been made to the Ministry of Health, Labour and Welfare regarding discrepancies between the approval documents and manufacturing practices. Consequently, on September 18, a request was made to suspend shipments and to submit proper reports. Subsequently, the Ministry of Health, Labour and Welfare has been reviewing the reported information.

It was found that appropriate reports had not been made to the Ministry of Health, Labour and Welfare regarding discrepancies between the approval document and manufacturing practices. Consequently, on September 18, a request was made to suspend shipments and to submit proper reports. Subsequently, the Ministry of Health, Labour and Welfare reviewed the reported information.

It was found that the product was manufactured using a method different from the approved method. - Heparin was added without being listed in the approval document. - Additives were used in quantities different from those specified in the approval document. - Some steps in the manufacturing process described in the approval document were modified or omitted.

Adding heparin not listed in the approval document. Using additives in amounts different from those specified in the approval document. Partially modifying or omitting steps described in the approval process.