In addition, a supplementary application for breast cancer has been submitted to the MHLW
in December 2018.
The breach was reportedly detected while the MHLW
was still to respond to the report of the Bureau of Plant Industry (BPI) regarding the latter's action that would ensure compliance by Filipino banana growers to the minimum residue limit (MRL) on banana exports.
It has been granted Breakthrough Therapy designation for the treatment of adult patients with relapsed/refractory FLT3-ITD AML by the FDA; Fast Track designation for the treatment of relapsed/refractory AML by the FDA; and, also has been granted Orphan Drug designation by both the FDA and the European Commission (EC) for the treatment of AML and by the Japan MHLW
for the treatment of FLT3-mutated AML.
At the same time the Japanese MHLW
added approval in use of EDTA collection tubes to the existing approval of heparin collection tubes used with this assay.
The application filing submitted to the MHLW
in July 2018 included data from Study CCT-001, a multicenter, randomized, double-blind, placebo-controlled, parallel-group phase 3 clinical trial investigating the efficacy, safety and pharmacokinetics of vedolizumab induction and maintenance treatment involving 157 Japanese patients with moderately to severely active CD, in addition to data from the global GEMINI 2 and 3 trials involving 1,115 and 416 patients respectively.1,2,3
CSI received MHLW
approval for the Diamondback 360[R] Coronary OAS Micro Crown in March 2017 and reimbursement approval in February 2018.
Officials from prefectures in which cases were confirmed made public announcements for most of these cases, and the MHLW
issued a press release to convey the information nationwide.
In conjunction with the pharmaceutical administration reform by the Japanese government, which requires to raise the adoption rate of generic drugs to 30%, at least 17 Taiwanese pharmaceutical makers have been field-certified by Japan's MHLW
and are ready to supply pharmaceutical companies in Japan.
Although Japan has lagged far behind in this field, I believe that approval by MHLW
under the new clinical research guidelines to study ADRCs for limb ischemia is a big step for medical care of vascularization therapy in Japan."
will need to complete certain additional steps, most notably an on-site inspection of CryoLife pursuant to Japanese Quality Management System requirements and required product reimbursement paperwork for Japanese authorities.
The PMDA revealed no significant observations, resulting in a recommendation to the MHLW
that HollisterStier be listed as an approved manufacturing site for the client's product.
Along with this new plan, the Ministry of Health, Labor and Welfare (MHLW
) and its evaluation agency, the Pharmaceuticals & Medical Devices Agency (PMDA), are going to reinforce the post-marketing surveillance system beginning in April.