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Recent Publications by PMDA Staffs

Papers and thesis posted by PMDA stuff, before 2016.
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.

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Regulatory Science

Title Authors Journal Publication Year
Approach to Establishment of Control Strategy for Oral Solid Dosage Forms Using Continuous Manufacturing Matsuda Y Chem Pharm Bull (Tokyo) . 2021 Feb 1;69(2):211-217. 2021
Applications of Physiologically Based Biopharmaceutics Modeling (PBBM) to Support Drug Product Quality: A Workshop Summary Report Mitra A, Suarez-Sharp S, Pepin XJH, Flanagan T, Zhao Y, Kotzagiorgis E, Parrott N, Sharan S, Tistaert C, Heimbach T, Zolnik B, Sjögren E, Wu F, Anand O, Kakar S, Li M, Veerasingham S, Kijima S, Lima Santos GM, Ning B, Raines K, Rullo G, Mandula H, Delvadia P, Dressman J, Dickinson PA, Babiskin A. J Pharm Sci. 2021 Feb;110(2):594-609. 2021
Meeting Report: PMDA Public Workshop on Pharmacometrics at Japan Kijima S, Ochiai Y, Ishiguro A CPT Pharmacometrics Syst Pharmacol. 2020 Oct;9(10):550-552. 2020
Preclinical safety assessments of mRNA-targeting oligonucleotide therapeutics Maki K Translat Regulat Sci. 2020
Aspects of gene therapy products using current genome-editing technology in Japan Yamaguchi T, Uchida E, Okada T, Ozawa K, Onodera M, Kume A, Shimada T, Takahashi S, Tani K, Nasu Y, Mashimo T, Mizuguchi H, Mitani K, Maki K Hum Gene Ther. 2020
Future development of artificial organs related with cutting edge emerging technology and their regulatory assessment: PMDA’s perspective Handa N, Mochizuki S, Fujiwara Y, Shimokawa M, Wakao R, Arai H J Artif Organs. 2020 Feb 28. doi: 10.1007/s10047-020-01161-4. 2020
Comparative Study of Pharmacopoeias in Japan, Europe, and the United States: Toward the Further Convergence of International Pharmacopoeial Standards Kameyama Y, Matsuhama M, Mizumaru C, Saito R,  Ando T, Miyazaki S Chemical and Pharmaceutical Bulletin. 67(12): 1301-1313 2019
The importance of a regulatory science approach for better pharmaceutical regulation Uyama Y Translat Regulat Sci. 1(1): 8-11. 2019
Regulatory/Scientific Supports for Micro-, Small-, and Medium-Sized Enterprises (SMEs) With Medicinal Products Provided by the PMDA and EMA Kondo H, Shibatsuji M, Yasuda N. Ther Innov Regul Sci. 2019 Mar;53(2):193-198. 2019
Promotion of Japan’s participation in global clinical trials Kondo H, Shimada Y, Ozawa T. Drug Discov Today. 2019 Jan 30. pii: S1359-6446(18)30508-7 2019
Applications of Clinically Relevant Dissolution Testing: Workshop Summary Report Suarez-Sharp S, Cohen M, Kesisoglou F, Abend A, Marroum P, Delvadia P, Kotzagiorgis E, Li M, Nordmark A, Bandi N, Sjögren E, Babiskin A, Heimbach T, Kijima S, Mandula H, Raines K, Seo P, Zhang X AAPS J. 20(6): 93 2018
What to Know About Medicines With New Active Ingredients Approved in FY 2016 / 2016 in Japan and EU : A Brief Comparison of New Medicines Approved in Japan and the EU in 2016 Kondo H, Saint-Raymond A, Yasuda N Therapeutic Innovation & Regulatory Science. 52(2) : 214-219 2018
Quantitative Modeling and Simulation in PMDA: A Japanese Regulatory Perspective. Sato M, Ochiai Y, Kijima S, Nagai N, Ando Y, Shikano M, Nomura Y CPT Pharmacometrics Syst Pharmacol. 6(7): 413-415 2017
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


New Drug

Title Authors Journal Publication Year
Study factors associated with the incompletion of clinical trials that include pediatric patients: a retrospective analysis of the European Clinical Trials Database and a lesson from the European region Tanemura N , Sasaki T, Sato J, Urushihara H Trials. 2021 Mar; 12;22(1):204. 2021
Real World Survey of Patient Engagement Status in Clinical Research: The First Input from Japan Tanemura N , Sasaki T, Sato J, Urushihara H  Patient. 2020 Oct; 13(5):623-632. 2020
Population pharmacokinetics of cefazolin before, during and after cardiopulmonary bypass in adult patients undergoing cardiac surgery Asada M, Nagata M, Mizuno T, Uchida T, Takahashi H, Makita K, Arai H, Kijima S, Echizen H, Yasuhara M. Eur J Clin Pharmacol. 2020 Nov 19. doi: 10.1007/s00228-020-03045-1. 2020
'All In': a pragmatic framework for COVID-19 testing and action on a global scale Pettit SD, Jerome KR, Rouquié D, Mari B, Barbry P, Kanda Y, Matsumoto M, Hester S, Wehmas L, Botten JW, Bruce EA. EMBO Mol Med. 2020 Jun 8;12(6):e12634. 2020
A Bayesian basket trial design accounting for uncertainties of homogeneity and heterogeneity of treatment effect among subpopulations Asano J,  Hirakawa A Pharmaceutical Statistics. 2020
Global Regulatory Landscape Matsuda Y AAPS PharmSciTech. 20(1):2. 2019
ESA Resistance May Be a Potential Confounder for Mortality among Different ESA Types. Tanaka M, Shinohara K, Ono A, Ikuma M. J Am Soc Nephrol. 30(9):1772. 2019
Pediatric drug regulation: International perspectives Baum VC, Bax R, Heon D, Yang Z, Sakiyama M. Paediatr Anaesth. 29(6): 572-582 2019
Population/regional differences in efficacy of three drug categories (antidiabetic, respiratory, and psychotropic agents) among East Asians: A retrospective study based on multi-regional clinical trials. Sai K, Yoshida A, Hanatani T, Imatoh T, Takeuchi M, Narukawa M, Watanabe H, Uyama Y, Saito Y Br J Clin Pharmacol. 85(6): 1270-1282. 2019
A Novel Method to Estimate Long‐Term Chronological Changes From Fragmented Observations in Disease Progression Ishida T, Tokuda K, Hisaka A, Honma M, Kijima S, Takatoku H, Iwatsubo T, Moritoyo T, Suzuki H; Alzheimer's Disease Neuroimaging Initiative Clin Pharmacol Ther. 2019 Feb;105(2):436-447 2019
Statistical testing strategies for assessing treatment efficacy and marker accuracy in phase III trials. Nonaka T, Igeta M, Matsui S. Pharm Stat. 2019; 18:459-475 2019
Master protocol trials in oncology: Review and new trial designs Hirakawa A, Asano J, Sato H, Teramukai S Contemporary Clinical Trials Communications. 12:1-8 2018
Impact of demographic factors on the antidepressant effect: A patient-level data analysis from depression trials submitted to the Pharmaceuticals and Medical Devices Agency in Japan. Nakabayashi T, Hara A, Minami H J Psychiatr Res. 2018 Mar;98:116-123 2018
Proposal for the development of biologics in pediatric rheumatology. Mori M, Nakagawa M, Tsuchida N, Kawada K, Sato J, Sakiyama M, Hirano S, Sato K, Nakamura H Pediatr Int. 60(2):108-114, 2018 2018
Factors Affecting Drug-Development Strategies in Asian Global Clinical Trials for Drug Approval in Japan Asano K, Uyama Y, Tohkin M Clin Transl Sci. 11(2):182-188 2018
Regulatory Perspectives on Continuous Pharmaceutical Manufacturing: Moving From Theory to Practice Nasr MM, Krumme M, Matsuda Y, Trout BL, Badman C, Mascia S, Cooney CL, Jensen KD, Florence A, Johnston C, Konstantinov K, Lee SL J Pharm Sci. 106(11): 3199-3206 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. 27(6):918-932. 2017
Utility of Adaptive Sample Size Designs and A Review Example Uemura K, Ando Y, Matsuyama Y Journal of Statistical Science and Application. 5: 1-15 2017
In vitro genotoxicity test package of antibiotics for human use submitted to the Japanese regulatory agency during 2004-2015 Sekizawa S, Hoshino Y, Takasu A Fundamental Toxicological Sciences. 4(5): 241-245 2017
Investigating toxicity specific to adjuvanted vaccines Matsumoto M, Komatsu S, Ikeda T, Shimomura K, Watanabe K, Hirabayashi K, Sawada J, Maki K, Shinoda K, Fueki O, Onodera H Regulatory Toxicology and Pharmacology. 91: 29-38 2017
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


Cellular and Tissue-based Products ・ Biologics

Title Authors Journal Publication Year
Application of Induced Pluripotent Stem Cells in Drug Discovery and Regenerative Medicine Maruyama Y, Tsunoda S, Saigo Y, Nozaka Y, Okudaira S, Kameda T, Hayashi Y, Izumi K, Maki K, Shinagawa K RSMP. 10(1): 33-40 2020
Experiences from Japan:
conditional and time-limited approval,
an early approval scheme for
regenerative medical products
Maruyama Y、Kasai M、 Fujiwara Y、Asano J、Jotatsu Y Cell & Gene Therapy Insights. 5(6), 561–568 2019
Experiences from Japan – SAKIGAKE Designation System for Regenerative Medical Products Maruyama Y, Kasai M, Oyama K, Chikazawa K Cell & Gene Therapy Insights. 4(6): 545-554 2018


OTC, Generic Drugs

Title Authors Journal Publication Year
Modernization and Strengthening of Bioequivalence Guidelines in Japan. Kuribayashi R, Yamaguchi T, Takagi K Clin Pharmacokinet. 2020 Nov 28. doi: 10.1007/s40262-020-00965-0 2020
Current Regulation for Bioequivalence Evaluations of Generic Ophthalmic Dosage Forms in Japan Myoenzono A, Kuribayashi R, Yamaguchi T, Ogawa T, Takagi K Eur J Drug Metab Pharmacokinet. 2020 Sep 15. 2020
First approval of generic dry powder Inhaler drug products in Japan Kuribayashi R, Myoenzono A Drug Deliv Transl Res. 2020 Oct;10(5):1517-1519. 2020
The Requirements for Additional Strength Biowaivers for Immediate Release Solid Oral Dosage Forms in International Pharmaceutical Regulators Programme Participating Regulators and Organisations: Differences and Commonalities. Crane C, Santos GML, Fernandes EAF, Simon C, Tam A, Triana DG, Potthast H, Kuribayashi R, Okada Y, Myoenzono A, Calderon IO, Rodriguez Z, Jones B, Park SA, Eum SY, Rodrigues C, Van Oudsthoorn J, Nolting A, Walther C, Roost MS, Hung WY, Braddy AC, Garcia-Arieta A. J Pharm Pharm Sci. 2019;22(1):486-500. 2019
Current Understanding of the Equivalence Evaluations for In Vitro Tests on Generic Dry Powder Inhaler Drug Products in Japan Kuribayashi R, Myoenzono A, Takagi K,  Hirota M Eur J Drug Metab Pharmacokinet. 2019 Dec;44(6):743-745 2019
A Survey of the Regulatory Requirements for the Acceptance of Foreign Comparator Products by Participating Regulators and Organizations of the International Generic Drug Regulators Programme Garcia Arieta A, Simon C, Lima Santos GM, Calderón Lojero IO, Rodríguez Martínez Z, Rodrigues C, Park SA, Kim JM, Kuribayashi R, Okada Y, Nolting A, Pfäffli C, Hung WY, Crane C, Braddy AC, Van Oudtshoorn J, Gutierrez Triana D, Clarke M. J Pharm Pharm Sci. 22(1): 28-36 2019
European Ethnopharmaceuticals for Self-Medication in Japan: Review Experience of Vitis vinifera L., Folium Extract and Vitex agnus-castus L., Fructus Extract as OTC Drugs Hoshino T, Muto N, Tsukada S, Nakamura T, Maegawa H Medicines. 5(1): 3 2018
Analysis of Drug Master Files registered in Japan: aiming for a stable supply of active pharmaceutical ingredients Matsuhama M, Kuribayashi R GaBI Journal. 7(1): 8-13 2018
A Survey of the Regulatory Requirements for BCS-Based Biowaivers for Solid Oral Dosage Forms by Participating Regulators and Organisations of the International Generic Drug Regulators Programme Van Oudtshoorn J, García-Arieta A, Santos GML, Crane C, Rodrigues C, Simon C, Kim JM, Park SA, Okada Y, Kuribayashi R, Pfäffli C, Nolting A, Lojero IOC, Martínez ZR, Hung WY, Braddy AC, Leal NA, Triana DG, Clarke M, Bachmann P. J Pharm Pharm Sci. 21 (1): 27-37 2018
Current Japanese Regulatory Systems for Generics and Biosimilars Kuribayashi R, Sawanobori K. J. Pharm. Sci. 107(3): 785-787 2018
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. 17(3): 371-379 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


Medical Devices

Title Authors Journal Publication Year
Pediatric Medical Devices
- Survey of Pediatric Cardiologists and Cardiovascular Surgeons in Japan -
Miyoshi T, Kato A, Yasukochi S, Takahashi S, Ho M,  Yamamoto H, Inuzuka R, Kim SH, Sakamoto K, Kobayashi T Circulation Reports
doi: 10.1253/circrep.CR-20-0136
Differences in clinical outcomes between pre- and post-marketing clinical study following paclitaxel-coated balloon catheter treatment for coronary in-stent restenosis: from the Japanese regulatory viewpoint MitsutakeY, Konishi A, Shiba T, Ito T, Ho M, Shirato H Heart Vessels. 2020 Aug 10. 2020
Independent Factors for In-Hospital Death Following Drug-Eluting Stent Thrombosis From the Japanese Adverse Event Report System Mitsutake Y, Konishi A , Handa N , Ho M , Shirato H , Ito T , Koike K , Mochizuki S , Ishii K  Circ J . 2020 Aug 25;84(9):1568-1574. 2020
Partnership between Japan and the United States for early development of pediatric medical devices
 -Harmonization By Doing for Children-

Takahashi S, Ibrahim N, Yasukochi S, Ringel R, Ing F, Tomita H, Sugiyama H, Yamagishi M, Forbes TJ, Kim SH, Ho M, Gillette N, Nakamura Y, Mineta K, Fearnot N, Dineen D, Vang E, Haskin R, Becker LAM, Sekiguchi K, Sakamoto K, Ruiz CE; Harmonization by Doing for Children Working Group.
Circ J. 84(5):786-791 2020
Evaluation of reoperations for removal of bioabsorbable plates and screws: based on adverse events reports from PMDA, Japan Kobayashi T, Handa N , Koike K, Mochizuki S,  Kaku I, Takae S BMJ Surg Interv Health Technologies 2020;2:e000033. doi:10.1136/bmjsit-2020-000033 2020
Recent Progress to Shorten Premarket Evaluation and Improve Patient Access to Medical Devices by the Pharmaceuticals and Medical Devices Agency of Japan Handa N, Takae S, Ishii K BMJ Surg Interv Health Technologies. 1-3 2019
Regulatory convergence of medical devices: a case study using ISO and IEC standards Imagawa K, Mizukami Y, Miyazaki S Expert Review of Medical Devices. 15(7): 497–504 2018
Learning Curves for Transcatheter Aortic Valve Implantation Under a Controlled Introduction System - Initial Analysis of a Japanese Nationwide Registry - Handa N, Kumamaru H, Torikai K, Kohsaka S, Takayama M, Kobayashi J, Ogawa H, Shirato H, Ishii K, Koike K, Yokoyama Y, Miyata H, Motomura N, Sawa Y, on behalf of Japanese TAVR Registry Participants Circ J. 82(7): 1951-1958 2018
First Approval of Improved Medical Device Conditional on Use-Result
Survey in Japan
-Regulatory Review of Polymer-Free Drug-Coated
BioFreedom Coronary Stent-
Konishi A, Ho M, Shirai Y, Shirato H. Circ J. 82(6):1487-1490. 2018
New Regulatory Framework for Medical Devices in Japan: Current Regulatory Considerations Regarding Clinical Studies. Konishi A, Isobe S, Sato D J Vasc Interv Radiol. 29(5):657-660. 2018
Registry Assessment of Peripheral Interventional Devices (RAPID)-Registry Assessment of Peripheral Interventional Devices Core Data Elements- Jones WS, Krucoff MW, Morales P, Wilgus RW, Heath AH, Williams MF, Tcheng JE, Marinac-Dabic JD, Malone ML, Reed TL, Fukaya R, Lookstein RA, Handa N, Aronow HD, Bertges DJ, Jaff MR, Tsai TT, Smale JA, Zaugg MJ, Thatcher RJ, Cronenwett JL Circ J. 82: 316-322 2018
Registry Assessment of Peripheral Interventional Devices (RAPID) : Registry Assessment of Peripheral Interventional Devices Core Data Elements Jones WS, Krucoff MW, Morales P, Wilgus RW, Heath AH, Williams MF, Tcheng JE, Marinac-Dabic JD, Malone ML, Reed TL, Fukaya R, Lookstein RA, Handa N, Aronow HD, Bertges DJ, Jaff MR, Tsai TT, Smale JA, Zaugg MJ, Thatcher RJ, Cronenwett JL J Vasc Surg. 67(2): 637-644.e30 2018
Effective Use of Foreign Clinical Data in Approvals for Medical Devices in Japan Shirotani M, Chiba K Journal of Regulatory Science. 05(2017) 35-49 2017
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



Title Authors Journal Publication Year
Interstitial Lung Disease as an Adverse Drug Reaction in Japan: Exploration of Regulatory Actions as a Basis for High Reporting. Iwasa E, Fujiyoshi Y, Kubota Y, Kimura R, Chandler RE, Taavola H, Norén GN, Wakao R. Drug Saf. 2020 Jul 2. 2020
Lower Proportion of Spontaneous Adverse Event Reports for Generic Drugs by Comparison With Original Branded Drugs at the Postmarket Stage in Japan Takami A, Hirata K, Ishiguro C, Hanaoka H, Uyama Y. Clin Pharmacol Ther. 105(6): 1471-1476. 2019
Data-driven identification of adverse event reporting patterns for Japan in the WHO global database of individual case safety reports Wakao R,  Iwasa E, Soejima S, Taavola H, Sandberg L,Chandler R, Norén GN. (WHO Collaborating Centre for International Drug Monitoring) Drug Saf. 2019 Dec;42(12): 1487-1498. 2019
Establishment of the  MID‐NET® medical information database network as a reliable and valuable database for drug safety assessments in Japan Yamaguchi M, Inomata S, Harada S, Matsuzaki Y, Kawaguchi M, Ujibe M, Kishiba M, Fujimura Y, Kimura M, Murata K, Nakashima N, Nakayama M, Ohe K, Orii T, Sueoka E, Suzuki T, Yokoi H, Takahashi F, Uyama Y Pharmacoepidemiol Drug Saf. (10):1395-1404. 2019
Cardiovascular risks associated with dipeptidyl peptidase‐4
inhibitors monotherapy compared with other antidiabetes
drugs in the Japanese population: A nationwide cohort study
Komamine M, Kajiyama K, Ishiguro C, Uyama Y Pharmacoepidemiol Drug Saf. 2019;1-9. 2019
Identification of gastrointestinal perforation based on ICD‐10
code in a Japanese administrative medical information
database and associated drug exposure risk factors
Tanigawa M, Kataoka Y, Kishino T, Kohama M,
Uyama Y, Suzuki Y, Yokoi H
Pharmacoepidemiol Drug Saf. 28(7):976-984 2019
The utilization and challenges of Japan's MID‐NET® medical information database network in postmarketing drug safety assessments: A summary of pilot pharmacoepidemiological studies Yamada K, Itoh M, Fujimura Y, Kimura M, Murata K, Nakashima N, Nakayama M, Ohe K, Orii T, Sueoka E, Suzuki T, Yokoi H, Ishiguro C, Uyama Y, on behalf of MID‐NET® project group Pharmacoepidemiol Drug Saf 28: 601-608. 2019
Oseltamivir phosphate—Lifting the restriction on its use to treat teenagers with influenza in Japan Takeuchi S, Tetsuhashi M, Sato D. Pharmacoepidemiol Drug Saf. 2019 Mar 4. doi: 10.1002/pds.4721 2019
The association between concerns toward adverse reactions during pre-approval drug reviews and the post-approval addition of clinically significant adverse reactions to package inserts: A retrospective analysis of pre-approval drug review reports and safety updates Watanabe K, Murakami M, Masuyama K, Ishiguro C, Matsuda T Pharmacoepidemiol Drug Saf. 27(11):1265-1276 2018
Analysis of safety-related regulatory actions by Japan's pharmaceutical regulatory agency. Ishiguro C, Misu T, Iwasa E, Izawa T. Pharmacoepidemiol Drug Saf. 26(11): 1314-1320 2017
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


Compliance (GCP, GLP etc)

Title Authors Journal Publication Year
A practice of expert review by read-across using QSAR Toolbox Fukuchi J, Kitazawa A, Hirabayashi K, Honma M. Mutagenesis. 2019 Mar 6;34(1):49-54 2019


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


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Recent Publications by PMDA Staffs