Pharmaceuticals and Medical Devices Agency PMDA

Tokyo, Japan

Pharmaceuticals and Medical Devices Agency PMDA

Tokyo, Japan

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PubMed | New York Stem Cell Foundation, Kindai University, World Health Organization, National Institute for Child Health and Development NICHD and 16 more.
Type: Congresses | Journal: Biologicals : journal of the International Association of Biological Standardization | Year: 2015

The regulation of human cell therapy products is a key factor in their development and use to treat human diseases. In that regard, there is a recognized need for a global effort to develop a set of common principles that may serve to facilitate a convergence of regulatory approaches to ensure the smooth and efficient evaluation of products. This conference, with experts from regulatory agencies, industry, and academia, contributed to the process of developing such a document. Elements that could form a minimum consensus package of requirements for evaluating human cell therapy products were the overall focus of the conference. The important regulatory considerations that are unique to human cell therapy products were highlighted. Sessions addressed specific points that are different from those of traditional biological/biotechnological protein products. Panel discussions complemented the presentations. The conference concluded that most of the current regulatory framework is appropriate for cell therapy, but there are some areas where the application of the requirements for traditional biologicals is inappropriate. In addition, it was agreed that there is a need for international consensus on core regulatory elements, and that one of the major international organizations should take the lead in formulating such a consensus document.


Otsubo Y.,Pharmaceuticals and Medical Devices Agency PMDA | Asahina Y.,Pharmaceuticals and Medical Devices Agency PMDA | Noguchi A.,Pharmaceuticals and Medical Devices Agency PMDA | Sato Y.,Pharmaceuticals and Medical Devices Agency PMDA | And 4 more authors.
Drug Metabolism and Pharmacokinetics | Year: 2012

Summary: Pharmacogenomics (PGx) has been utilized as a tool to improve a drug's benefit/risk ratio and the efficiency of drug developments. In order to examine what factors are involved to determine the level of contexts (contents and descriptions) of drug-PGx biomarker information, we graded sections of Japanese package inserts and US drug labels into six levels according to the importance of cautions in regards to clinical practice and compared similarities and differences of the contexts between the two countries. Out of 54 contexts identified, 33 (61%) were graded differently between Japan and the US. The different contexts were mainly related to metabolizing enzymes used in terms of safety, therapeutic areas other than oncology, outcome before 1993, Japan-based companies having marketing authorization and no PGx data on the Japanese population. We describe the potential reasons that could lead to the differences between the two countries such as genetic differences and quantitative evidence in the Japanese population, and also discuss future perspectives to improve PGx utilization in clinical practices in Japan. © 2012 by the Japanese Society for the Study of Xenobiotics (JSSX).


Otsubo Y.,Pharmaceuticals and Medical Devices Agency PMDA | Ishiguro A.,Pharmaceuticals and Medical Devices Agency PMDA | Uyama Y.,Pharmaceuticals and Medical Devices Agency PMDA | Uyama Y.,Chiba University
Pharmacogenomics | Year: 2013

Pharmacogenomics-guided drug development has been implemented in practice in the last decade, resulting in increased labeling of drugs with pharmacogenomic information. However, there are still many challenges remaining in utilizing this process. Here, we describe such remaining challenges from the regulatory perspective, specifically focusing on sample collection, biomarker qualification, ethnic factors, codevelopment of companion diagnostics and means to provide drugs for off-target patients. To improve the situation, it is important to strengthen international harmonization and collaboration among academia, industries and regulatory agencies, followed by the establishment of an international guideline on this topic. Communication with a regulatory agency from an early stage of drug development is also a key to success. © 2013 Future Medicine Ltd.


Asano K.,Pharmaceuticals and Medical Devices Agency PMDA | Tanaka A.,Pharmaceuticals and Medical Devices Agency PMDA | Sato T.,Pharmaceuticals and Medical Devices Agency PMDA | Uyama Y.,Pharmaceuticals and Medical Devices Agency PMDA
Clinical Pharmacology and Therapeutics | Year: 2013

Regulatory agencies face challenges in reviewing data from global clinical trials (GCTs) in the era of globalization of drug development. One major challenge is consideration of ethnic factors in evaluating GCT data so as to extrapolate foreign population data to one's own national population. Here, we present the Pharmaceuticals and Medical Devices Agency (PMDA) perspective in reviewing GCT data in new drug applications (NDAs) and discuss future challenges for new drug approval. © 2013 American Society for Clinical Pharmacology and therapeutics.


Nagai N.,Pharmaceuticals and Medical Devices Agency PMDA
Drug Metabolism and Pharmacokinetics | Year: 2010

Drug interaction studies on new drug applications (NDAs) for new molecular entities (NMEs) approved in Japan between 1997 and 2008 are examined in the Pharmaceuticals and Medical Devices Agency (PMDA). The situations of drug interaction studies in NDAs have changed over the past 12 years, especially in metabolizing enzyme and transporter-based drug interactions. Materials and approaches to study drugmetabolizing enzyme-based drug interactions have improved, and become more rational based on mechanistic theory and new technologies. On the basis of incremental evidence of transporter roles in human pharmacokinetics, transporter-based drug interactions have been increasingly studied during drug development and submitted in recent NDAs. Some recently approved NMEs include transporter-based drug interaction information in their package inserts (PIs). The regulatory document "Methods of Drug Interaction Studies," in addition to recent advances in science and technology, has also contributed to plan and evaluation of drug interaction studies in recent new drug development. This review summarizes current situations and further discussion points on drug interaction studies in NDAs in Japan.


Asahina Y.,Pharmaceuticals and Medical Devices Agency PMDA | Sugano H.,Pharmaceuticals and Medical Devices Agency PMDA | Sugiyama E.,Pharmaceuticals and Medical Devices Agency PMDA | Uyama Y.,Pharmaceuticals and Medical Devices Agency PMDA
Journal of Nutrition, Health and Aging | Year: 2014

To examine how target patients seen in clinical practice are represented in clinical trials for approved drugs in Japan, we compared the age distribution of older patients enrolled in confirmatory clinical trials for regulatory approval with that of the estimated actual patient population. Drugs for 6 chronic conditions common among older patients (diabetes mellitus, hypertension, rheumatoid arthritis, non-small cell lung cancer, depression and Alzheimer's disease) launched by 2012 in Japan were selected. The disparity in age distribution between patients in trials and patients seen in clinical practice varied depending on the disease, but older patients, especially those aged 75 or older, were generally underrepresented in clinical trials for regulatory approval in Japan. Under-representation of older patients in hypertension trials was particularly marked compared to other conditions, despite the similarity in age distribution of patients seen in clinical practice. One factor causing this disparity may be an upper age limit in clinical trial protocols. More effort is needed to properly characterize the benefits and risks of drugs for older patients. This should include the active enrollment of older patients in clinical trials, the establishment of better assessment tools such as pharmacometric approaches, and the appropriate planning and conducting of post-marketing surveys and studies.


Ishikawa H.,Pharmaceuticals and Medical Devices Agency PMDA
Transactions of Japanese Society for Medical and Biological Engineering | Year: 2014

Introduction and consultation about quality and safety view from the initial stage of the development in order to create innovative medical devices. This consultation system is mainly for University, Laboratories and venture companies who has very progressive idea or studies but the little experience bout the regulation. © 2014, Japan Soc. of Med. Electronics and Biol. Engineering. All rights reserved.


Katayama R.,Massachusetts General Hospital | Katayama R.,Harvard University | Aoyama A.,Divisions of Experimental Chemotherapy | Aoyama A.,Tokyo Medical University | And 8 more authors.
Cancer Research | Year: 2013

The receptor tyrosine kinase c-MET is the high-affinity receptor for the hepatocyte growth factor (HGF). The HGF/c-MET axis is often dysregulated in tumors. c-MET activation can be caused by MET gene amplification, activating mutations, and auto- or paracrine mechanisms. Thus, c-MET inhibitors are under development as anticancer drugs. Tivantinib (ARQ 197) was reported as a small-molecule c-MET inhibitor and early clinical studies suggest antitumor activity. To assess whether the antitumor activity of tivantinib was due to inhibition of c-MET, we compared the activity of tivantinib with other c-MET inhibitors in both c-MET-addicted and nonaddicted cancer cells. As expected, other c-MET inhibitors, crizotinib and PHA-665752, suppressed the growth of c-MET-addicted cancers, but not the growth of cancers that are not addicted to c-MET. In contrast, tivantinib inhibited cell viability with similar potency in both c-MET-addicted and nonaddicted cells. These results suggest that tivantinib exhibits its antitumor activity in a manner independent of c-MET status. Tivantinib treatment induced a G2-M cell-cycle arrest in EBC1 cells similarly to vincristine treatment, whereas PHA-665752 or crizotinib treatment markedly induced G0-G1 cell-cycle arrest. To identify the additional molecular target of tivantinib, we conducted COMPARE analysis, an in silico screening of a database of drug sensitivities across 39 cancer cell lines (JFCR39), and identified microtubule as a target of tivantinib. Tivantinib-treated cells showed typical microtubule disruption similar to vincristine and inhibited microtubule assembly in vitro. These results suggest that tivantinib inhibits microtubule polymerization in addition to inhibiting c-MET. Cancer Res; 73(10); 3087-96. © 2013 AACR.


Asahina Y.,Pharmaceuticals and Medical Devices Agency PMDA | Tanaka A.,Pharmaceuticals and Medical Devices Agency PMDA | Uyama Y.,Pharmaceuticals and Medical Devices Agency PMDA | Kuramochi K.,Pharmaceuticals and Medical Devices Agency PMDA | Maruyama H.,Pharmaceuticals and Medical Devices Agency PMDA
Therapeutic Innovation and Regulatory Science | Year: 2013

Recently, it is becoming increasingly difficult to develop innovative drugs. Thus, the role of regulatory science research in drug development and postmarketing settings has become more important. In this article, the authors discuss the roles of regulatory science research at the Pharmaceuticals and Medical Devices Agency (PMDA), which aims to improve public health in Japan. © The Author(s) 2013.


PubMed | Pharmaceuticals and Medical Devices Agency PMDA
Type: Journal Article | Journal: Yakugaku zasshi : Journal of the Pharmaceutical Society of Japan | Year: 2016

The review of drugs and medical devices is an integral part of regulatory science. The Pharmaceuticals and Medical Devices Agency (PMDA) evaluates the efficacy, safety, and quality of drugs and medical devices after applications are submitted for regulatory approval. The products are approved when their benefits exceed their risks, i.e., an application is approved if the efficacy of the product in patients was demonstrated and the safety of the product is acceptable in view of its observed benefits. However, drugs and medical devices for which efficacy was not clearly demonstrated in clinical trials makes the decision to approve a difficult process. Under those circumstances, the approval process is based on the totality of information, such as the reason why clinical trials did not succeed and medical needs in Japan. The Wingspan stent system, which was approved for the treatment of intracranial arterial stenosis, is an example of a product with a use different from that intended by the US Food and Drug Administration and PMDA.

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