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Recent Publications by PMDA Staffs

In this page, information regarding scientific articles to which PMDA members contributed is provided. Please note that it may include views of the author and does not necessarily reflect the official views of PMDA. PMDA encourages the regulatory science research by its staff with various expertise and perspectives for improving the quality of PMDA's services and operations.

 

PMDA Policy

Title Authors Journal Publication Year
International Vision and strategy for Drug Regulatory authority: The PMDA's International Vision Tominaga T,
Ando Y,
Kondo T
Clin Pharmacol Ther. 92(3): 349-51 2012


New Drug

Title Authors Journal Publication Year
Prevention of sudden cardiac death in the young: Developing a rational, reliable, and sustainable national health care resource. A report from the Cardiac Safety Research Consortium Idriss SF, Berger S, Harmon KG, Kindman A,  Kleiman R, Lopez-Anderson M, Molossi S,
Saarel T,  Strnadova C, Todaro TG, Shinagawa K,
Morrow V, Krucoff M, Vetter V, Wright TJ
Am Heart J. 190: 123-131 2017
Clarifying the Discussion Points in New Drug Application Reviews for Approval in Japan by a Government Advisory Council Hattori Y, Hanaoka H, Uyama Y Therapeutic Innovation & Regulatory Science. DOI: 10.1177/2168479017696271 2017
Non-neoplastic lesions found only in the two-year bioassays but not in shorter toxicity studies of rats Nonaka M, Amakasu K, Saegusa Y, Naota M, Nishimura T, Ogawa K, Nishikawa A. Regul Toxicol Pharmacol. 86: 199-204 2017
Assessing the prediction accuracy of a cure model for censored survival data with long-term survivors: application to breast cancer data Asano J, Hirakawa A J Biopharm Stat. DOI: 10.1080/10543406. 2017
Heart Failure Clinical Trials in East and Southeast Asia:
Understanding the Importance and Defining the Next Steps
Mentz RJ, Roessig L, Greenberg BH, Sato N, Shinagawa K, Yeo D, Kwok BW, Reyes EB, Krum H, Pieske B, Greene SJ, Ambrosy AP, Kelly JP, Zannad F, Pitt B, Lam CS JACC: Heart Fail. 4(6): 419-427 2016
Comparison of Drug Use Between Clinical Practice and Regulatory Approval: Results in Older Japanese Patients With Rheumatoid Arthritis, Diabetes, High Blood Pressure, or Depression. Tanemura N, Uyama Y, Nagashima K, Suzuki T, Asahina Y, Kobayashi Y, Iyo M, Yokote K, Hanaoka H Therapeutic Innovation & Regulatory Science. 1-9 2016
Absence of ethnic differences in the pharmacokinetics of moxifloxacin, simvastatin, and meloxicam among three East Asian populations and Caucasians. Hasunuma T, Tohkin M, Kaniwa N, Jang IJ, Yimin C, Kaneko M, Saito Y, Takeuchi M, Watanabe H, Yamazoe Y, Uyama Y, Kawai S. Br J Clin Pharmacol. 1078-1090 2016
Elderly-specific revisions of drug prescribing information in the postmarketing environment in Japan. Asahina Y, Sugiyama E, Sugano H, Uyama Y. J Aging Res Clin Practice. 5(2): 71-76 2016
Evolving Japanese regulations on companion diagnostics Nagai S, Urata M, Sato H, Mikami M, Kuga W, Yanagihara R, Miyamoto D, Suzuki Y, Shikano M Nat Biotechnol. 34(2): 141-144 2016
Note on Regulatory Toxicology Requirements for Adjuvants and Vaccines; in View of the Newly Established WHO Guidelines Matsumoto M, Komatsu S, Matsui H, Shimomura K, Watanabe K, Amakasu K, Fueki O, Sawada J, Maki K, Shinoda K, Onodera H. Journal of Medical Toxicology and Clinical Forensic Medicine. 1(2:8): 1-5 2015
How Should Ethnicity-Related Information Be Included on Drug Labels? Considerations Based on Comparison of Multiregional Clinical Trial Data on the Label Between Japan and the United States Tanaka A,
Asano K,
Uyama Y.
Clin Pharmacol Ther. doi:10.1002/cpt.197 2015
Exposure of Drugs for Hypertension, Diabetes, and Autoimmune Disease During Pregnancy and Perinatal Outcomes: An Investigation of the Regulator in Japan. Sato R, Ikuma M, Takagi K, Yamagishi Y, Asano J, Matsunaga Y, Watanabe H. Medicine (Baltimore). 94(1): 1-9 2015
Clinical Development and Regulatory Approval of Acute Heart Failure Drugs in Japan Shinagawa K Cardiovasc Drugs Ther. DOI 10.1007/s10557-015-6579-4 2015
Safety of vaccine adjuvants: Focus on autoimmunity. van der Laan JW, Gould S, Tanir JY; ILSI HESI Vaccines and Adjuvants Safety Project Committee Vaccine 33(2015) 1507-1514 2015
Phase III All-Comers Clinical Trials with a Predictive Biomarker Matsui S, Choai Y, Nonaka T Design and Analysis of Clinical Trials for Predictive Medicine. 165-185 2014
Considerations for non-clinical safety studies of therapeutic peptide Vaccines Matsumoto M, Komatsu S, Tsuchimoto M, Matsui H, Watanabe K, Nakamura K, Amakasu K, Ito K, Fueki O, Sawada J, Maki K, Onodera H. Regul Toxicol Pharmacol. 70(1); 254-260 2014
Biomarker-Based Designs of Phase III Clinical Trials for Personalized Medicine Matsui S, Nonaka T, Choai Y Developments in Statistical Evaluation of Clinical Trials. 247-263 2014
General Principles for the Education and Training of GCP Inspectors: The Outcome of Discussions by International Regulatory Experts in the Discussion Group on ICH E6 guideline. Uyama Y, Yamazaki E, Osawa T. et al. Ther Innov Regul Sci. DOI: 10.1177/2168479014551646 2014
Clinical development and trial design of biosimilar products: A japanese perspective Nagasaki M, Ando Y J Biopharm Stat, 24: 1165-1172 2014
Relationship between drug lag and factors associated with clinical trials in Japan Ohwaki K, Nakabayashi T J Clin Pharm Ther. 39(6):649-52 2014
Regulatory activities to address the needs of older patients Cerreta F, Temple R, Asahina Y, Connaire C J Nutr Health Aging. 10.1007/s12603-014-0494-4, 2014 2014
Assessing the prediction accuracy of cure in the Cox proportional hazards cure model: an application to breast cancer data Asano J, Hirakawa A, Hamada C, Pharmaceut Statist. DOI: 10.1002/pst.1630 2014
Moving Beyond the Hazard Ratio in Quantifying the Between-Group Difference in Survival Analysis Uno H, Claggett B, Tian L, Inoue E, Gallo P, Miyata T, Schrag D, Takeuchi M, Uyama Y, Zhao L, Skali H, Solomon S, Jacobus S, Hughes M, Packer M, Wei L J Clin Oncol. DOI: 10.1200/JCO.2014.55.2208 2014
Comparison of Statistical Analysis Plans in Randomize-All Phase III Trials with a Predictive Biomaker Matsui S, Choai Y, Nonaka T Clin Cancer Res. DOI: 10.1158/1078-0432.CCR-13-2698 2014
Drug discovery in renal disease-towards a more efficient framework Ando T, Hiragi H, Watanabe K, Yamamoto F Nat Rev nephrology. 10, 290-296 2014
Representation of older patients in clinical trials for drug approval in Japan Asahina Y, Sugano H, Sugiyama E, Uyama Y J Nutr Health Aging 2014;18(5):520-23. 2014
Significant Differences in Drug Lag in Clinical Development Among Various Strategies Used for Regulatory Submissions in Japan Ueno T, Asahina Y, Tanaka A, Yamada H, Nakamura M, Uyama Y Clin Pharmacol Ther. 2014, DOI: 10.1038/clpt.2013.223 2014
Exploring Ethnic Differences in Toxicity in Early-Phase Clinical Trials for Oncology Drugs Ogura T, Morita S, Yonemori K, Nonaka T, Urano T Ther Innov Regul Sci. DOI: 10.1177/2168479014524582 2014
A stepwise variable selection for a Cox proportional hazards cure model with application to breast cancer data Asano J, Hirakawa A, Hamada C Jpn J Biomet. 34(1): 21-34 2013
Recent trends and special topics in new drug review in PMDA Sugita T GaBiJournal. 2(2)99-100. DOI:10.5639/gabij.2013.0202.024 2013
Regulatory Experience at the FDA, EMA, and PMDA. -Regulatory Experience at the PMDA.- Ishiguro A, Otsubo Y, Uyama Y Biomarker Qualification. 41-44 2013
Regulatory Challenges in the Review of Data from Global Clinical Trials: The PMDA Perspective Asano K, Tanaka A, Sato T, Uyama Y Clin Pharmacol Ther. 94(2): 195-198 2013
The Roles of Regulatory Science Research in Drug Development at the Pharmaceuticals and Medical Devices Agency of Japan Asahina Y, Tanaka A, Uyama Y, Kuramochi K, Maruyama H Ther Innov Regul Sci. 47(1): 19-22 2013
Good Laboratory Practice Inspections in Japan Between Fiscal Years 2009-2011 Anahara R Ther Innov Regul Sci. 47(4): 424-429 2013
Characteristics of pharmacogenomics / biomarker-guided clinical trials for regulatory approval of anti-cancer drugs in Japan Ishiguro A,
Yagi S,
Uyama Y
J Hum Genet: 1-4 2013
Balancing Societal Needs and Regulatory Certainty: The Case Study of Peramivir in Japan Tominaga T,
Ando Y,
Nagai N,
Sato J,
Kondo T
Clin Pharmacol Ther. 93(4): 342-4 2013
Pharmacogenetics in the evaluation of new drugs: a multiregional regulatory perspective Maliepaard M, Nofziger C, Papaluca M, Zineh I, Uyama Y, Prasad K, Grimstein C, Pacanowski M, Ehmann F, Dossena S, Paulmichl M. Nat Rev Drug Discov.12(2): 103-115 2013
Regulatory perspective on remaining challenges for utilization of pharmacogenomics-guided drug developments Otsubo Y, Ishiguro A, Uyama Y Pharmacogenomics. 14(2):195-203 2013
Improving clinical trial sampling for future research - an international approach: outcomes and next steps from the DIA future use sampling workshop 2011 Warner AW, Bienfait KL, Bledsoe M, Burckart G, Flamion B, Knoppers B, Nelsen AJ, Rudman A, Sieffert NJ, Uyama Y Pharmacogenomics. 14(1):103-112 2013
Perspectives on non-clinical safety evaluation of drug metabolites through the JSOT workshop Minagawa T, Nakano K, Furuta S, Iwasa T, Takekawa K, Minato K, Koga T, Sato T, Kawashima K, Kurahashi Y, Onodera H, Naito S, Nakamura K J Toxicol Sci. 37(4): 667-673 2012
Multiregional Clinical Trials: Japanese Perspective on Drug Development Strategy and Sample Size for Japanese Subjects Ando Y, Uyama Y J Biopharm Stat 22(5): 977-987 2012
Similarities and differences between US and Japan as to Pharmacogenomic Biomarker information in drug labels Otsubo Y, Asahina Y, Noguchi A, Sato Y, Ando Y, Uyama Y Drug Metab. Pharmacokinet. 27(1): 142-149 2012
The value and benefits of the international conference on harmonisation to drug regulatory authorities: advancing harmonization for better public health Molzon JA, Giaquinto A, Lindstrom L, Tominaga T, Ward M, Doerr P, Hunt L, Rago L. Clin Pharmacol Ther. 89(4): 503-12 2011
Adaptive clinical trials for new drug applications in Japan Ando Y, Hirakawa A, Uyama Y Eur Neuropsychopharmacol. 21: 175-179 2011


Cellular and Tissue-based Products ・ Biologics

Title Authors Journal Publication Year
Report of the International Regulatory Forum on Human Cell Therapy and Gene Therapy Products Hayakawa T, Harris I, Joung J, Kanai N, Kawamata S, Kellathur S, Koga J, Lin YC, Maruyama Y, McBlane J, Nishimura T, Renner M, Ridgway A, Salmikangas P, Sakamoto N, Sato D, Sato Y, Toda Y, Umezawa A, Werner M, Wicks S Biologicals. 44: 467-479 2016
Response to Nature's editorial regarding the Japanese legal system for regenerative medicines Sato D, Arakawa Y, Isobe S Regenerative Therapy. 4(2016): 103-104 2016
Japan's challenges of translational regenerative medicine: Act on the safety of regenerative medicine Tobita M, Konomi K, Torashima Y, Kimura K, Taoka M, Kaminota M Regenerative Therapy. 4(2016): 78-81 2016
First Approval of Regenerative Medical Products under the PMD Act in Japan Konishi A, Sakushima K, Isobe S, Sato D Cell Stem Cell. 18(4): 434-435 2016
Regulatory Frameworks for Gene and Cell Therapies in Japan Maeda D, Yamaguchi T, Ishizuka T, Hirata M, Takekita K, Sato D Adv Exp Med Biol. 871: 147-162 2015
Report of the international conference on regulatory endeavors towards the sound development of human cell therapy products Hayakawa T, Aoi T, Bravery C, Hoogendoorn K, Knezevic I, Koga J, Maeda D, Matsuyama A, McBlane J, Morio T, Petricciani J, Rao M, Ridgway A, Sato D, Sato Y, Stacey G, Sakamoto N, Trouvin JH, Umezawa A, Yamato M, Yano K, Yokote H, Yoshimatsu K, Zorzi-Morre P. Biologicals. 43(5):283-297 2015
Consideration of and expectations for the Pharmaceuticals, Medical Devices and Other Therapeutic Products Act in Japan Okada K,
Koike K,
Sawa Y
Regenerative Therapy 1(2015) 80-83 2015
New Japanese Initiatives on Stem Cell Therapies Konomi K, Tobita M, Kimura K, Sato D Cell Stem Cell. 16 (4): 350-352 2015
New Governmental Regulatory System for Stem Cell-Based Therapies in Japan. Hara A, Sato D, Sahara Y. Ther Innov Regul Sci. 2014; 48(6): 681-688 2014
Overview of global regulatory toxicology requirements for vaccines and adjuvants Sun Y, Gruber M, Matsumoto M. J Pharmacol Toxicol Methods. 65(2): 49-57 2012
A comparative study of monosaccharide composition analysis as a carbohydrate test for biopharmaceuticals Harazono A, Kobayashi T, Kawasaki N, Itoh S, Tada M, Hashii N, Ishii A, Arato T et al Biologicals. 39: 171-180 2011
Experience of reviewing the follow-on biologics including Somatropin and erythropoietin in Japan Arato T, Yamaguchi T Biologicals. 39: 289-292 2011
Quality, safety and efficacy of follow-on biologics in Japan Yamaguchi T, Arato T Biologicals. 39: 328-332 2011


Medical Devices

Title Authors Journal Publication Year
Clinical Trial Design of Medical Devices Approved by the Pharmaceuticals and Medical Devices Agency of Japan Handa N, Ho M, Sato T, Kondo T International Journal of Current Research. 9(8): 55829-55831 2017
Nationwide Registries Associated with Cardiovascular Medical Devices in Japan Handa N, Ishii K, Koike K, Kumamaru H, Miyata H, Motomura N Pharm Regul Aff. 5:2. DOI: 10.4172/2167-7689.1000177 2016
Reporting of Cardiovascular Medical Device Adverse Events to Pharmaceuticals and Medical Devices Agency, Japan Handa N, Ishii K, Matsui Y, Ando Y. E BioMedicine. 2(9): 1211-1216 2015
The role of the Pharmaceuticals and Medical Devices Agency and healthcare professionals in post-marketing safety Mori K, Watanabe M, Horiuchi N, Tamura A, Kutsumi H Clin J Gastroenterol. DOI 10.1007/s12328-014-0474-6 2014


Safety

Title Authors Journal Publication Year
Risk of Acute Asthma Attacks Associated With Nonsteroidal Anti-inflammatory Drugs: A Self-Controlled Case Series Takeuchi Y,
Ando T,
Ishiguro C,
Uyama Y
Therapeutic Innovation & Regulatory Science. 51(3): 332-341 2017
The MIHARI project: establishing a new framework for pharmacoepidemiological drug safety assessments by the Pharmaceuticals and Medical Devices Agency of Japan Ishiguro C, Takeuchi Y, Uyama Y, Tawaragi T Pharmacoepidemiol Drug Saf. 25(7): 854-859 2016
Adverse events associated with incretin-based drugs in Japanese spontaneous reports: a mixed effects logistic regression model Narushima D, Kawasaki Y, Takamatsu S, Yamada H Peer J. DOI: 10.7717/peerj.1753, page10 2016
Atypical Antipsychotics and the Risk of Hyperlipidemia: A Sequence Symmetry Analysis Takeuchi Y, Kajiyama K, Ishiguro C, Uyama Y. Drug Saf. 38(7): 641-650 2015
Analysis of the Factors Influencing the Spontaneous Reporting Frequency of Drug Safety Issues Addressed in the FDA's Drug Safety Communications, Using FAERS Data Ishiguro C, Hinomura Y, Uehara K, Matsuda T Pharm Med. 28(1):7-19 2014
Post-approval appending of CSARs to drug package inserts: an analysis of the types of adverse reactions and time to addition Tamura N, Ishiguro C, Matsuda T Pharmacoepidemiol Drug Saf. 2014; doi: 10.1002/pds.3629. 2014
Assessment of Postmarketing Safety-Related Regulatory Actions in Japan Ogami T, Imaizumi T, Ishiguro C, Matsuda T Pharm Med. 26(6):395-403 2012


Relief Funds

Title Authors Journal Publication Year
The Japanese Postmarketing Adverse Event Relief System: A Confluence of Regulatory Science, the Legal System, and Clinical Pharmacology Tominaga T,  Miyazaki S,  Oniyama Y,  Weber AD,  Kondo T Clinical Pharmacology & Therapeutics. 102(2): 277-282 2017


Regulatory Science

Title Authors Journal Publication Year
A Comparison of PMDA and EMA Consultations for Regulatory and Scientific Matters in Drugs and Regenerative Medicine Products Kondo H, Sugita T, Ida N, Fukushima H, Yasuda N Therapeutic Innovation & Regulatory Science. 51(3): 355-359 2017
The Current Status of Sakigake Designation in Japan, PRIME in the European Union, and Breakthrough Therapy Designation in the United States Kondo H,
Hata T,
Ito K,
Koike H,
Kono N
Therapeutic Innovation & Regulatory Science. 51(1): 51-54 2017
Regulatory Science as a Bridge Between Science and Society Tominaga T, Asahina Y, Uyama Y, Kondo T Clin Pharmacol Ther. 90(1): 29-31 2011


OTC, Generic Drugs

Title Authors Journal Publication Year
Establishment of Application Guidance for OTC non-Kampo Crude Drug Extract Products in Japan Somekawa L, Maegawa H, Tsukada S, Nakamura T Journal of Intercultural Ethnopharmacology. 6(3): 333-338 2017
Comparison of Generic Drug Reviews for Marketing Authorization between Japan and Canada. Kuribayashi R,  Appleton S. Drugs R D. 2017 Jun 2. doi: 10.1007/s40268-017-0186-8 2017
The Self-medication Collaborative Asian Regulator Expert Roundtable (Self-CARER) Weber AD, Kitahara J, Katsura Y, Yasuda N WHO Drug Information. 31(1): 11-14 2017
Bioequivalence Evaluations of Generic Dry Powder Inhaler Drug Products: Similarities and Differences Between Japan, USA, and the European Union. Kuribayashi R, Yamaguchi T, Sako H, Takishita T, Takagi K. Clin Pharmacokinet. 56(3): 225-233 2017
Similarities and Differences of International Practices and Procedures for the Regulation for Active Substance Master Files/Drug Master Files of Human Use: Moving Toward Regulatory Convergence. Matsuhama M, Takishita T, Kuribayashi R, Takagi K, Wakao R, Mikami K J Pharm Pharm Sci. 19(2): 290-300 2016
Regulatory Considerations of Bioequivalence Studies for Oral Solid Dosage Forms in Japan. Kuribayashi R, Takishita T, Mikami K J Pharm Sci. 105(8): 2270-2277 2016
Regulation of Generic Drugs in Japan: the Current Situation and Future Prospects. Kuribayashi R, Matsuhama M, Mikami K AAPS J. 17(5):1312-1316 2015
Regulation of traditional herbal medicinal products in Japan Maegawa H, Nakamura T, Saito K J Ethnopharmacol.158: 511-515 2014

 

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