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| 1974 | 2 | 1 | 125 | Yorio Satoh | |||
| 1974 | 2 | 2 | 299 | Controlled Committee | |||
| 1974 | 2 | 2 | 313 | Controller Committee | |||
| 1975 | 3 | 1 | 99 | Research, Development, and Demonstration Activities: Limitations of Informed Consent－Special Policy Considerations | National Institutes of Health | Tadahio MItsuishi | Federal Register, Vol.38,No.221, Nov.16,1973 |
| 1975 | 3 | 1 | 99 | Controlled Committee | |||
| 1975 | 3 | 1 | 117 | Controller Committee | |||
| 1975 | 3 | 2 | 271 | Research, Development, and Demonstration Activities(2): Limitations of Informed Consent－Special Policy Considerations | National Institutes of Health | Tadahiro Mitsuishi | Federal Register, Vol.38,No.221, Nov.16,1973 |
| 1976 | 4 | 1 | 145 | On the New Version of The Declaration of Helsinki, as revised 1975 | Haruo Miyano | ||
| 1976 | 4 | 1 | 155 | What is the significance of the 1975 revision of the 1964 Helsinki Declaration to the freedom and safety of the individual who subjected to clinical research? | Tadahiro Mituishi | ||
| 1976 | 4 | 1 | 161 | DECLARATION OF HELSINKI, 1964 Revised [Originally 1962] | World Medical Association | ||
| 1976 | 4 | 1 | 163 | THE WORLD MEDICAL ASSOCIATION, INC. DRAFT DECLARATION OF HELSINKI Recommendaions guiding medical doctors in biomedical research | World Medical Association | ||
| 1976 | 4 | 1 | 165 | Notes on Applications for Manufacturing (or Importing) Approval of New Drugs | Controller Committee | ||
| 1976 | 4 | 2 | 277 | SCHMIDT TESTIMONY:FDA commissioner addresses sen. Kennedy's subcomte. about the use of human subjects for drug investigation | FDA | Controller Committee | DRUG RESEARCH REPORTS "The Blue Sheet" July 23,1975 |
| 1976 | 4 | 2 | 305 | PMA CLINICAL RESEARCH POLYCY:PMA polycy outlines recommendations for clinical research on human subjects including prisoners and the mentally infirm | The Pharmaceutical Mfc. Assn. PMA |
Controller Committee | DRUG RESEARCH REPORTS "The Blue Sheet" July 23,1975 |
| 1976 | 4 | 3 | 549 | Text of Electronic Data Processing System on Drug Evaluation －Cross-Over Comparison(D5)－ | Controller Committee | Federal Resister, Nov.19, 1976 | |
| 1977 | 5 | 1 | 135 | Introduction to the Proposed Good Laboratory Practice Regulation(GLP) by FDA | FDA | Controller Committee | Federak Resister, Nov.19,1976 |
| 1977 | 5 | 1 | 149 | FDA Guidelines for Psychotropic Drugs | FDA | Hitoshi Itoh, Shigeo Kaizawa, Sadanori Miura et al. |
ECDEU intercom Jan. 1975 |
| 1977 | 5 | 2 | 447 | Influence of Pharmaceutial Industries on Post-graduate Education of Medical Doctors in the United States－With Special Reference to the Statement of FDA BuDirector at House Hearing | FDA | Controller Committee | |
| 1977 | 5 | 3 | 687 | Text of Electronic Data Processing System on Drug Evaluation－Part 1:Inter-Group Comparison (D4)(English Translation)－(English Translation) | Controller Committee | ||
| 1977 | 5 | 3 | 703 | Guideline to Clinical Trials of Anti-hypertensive Drugs | Msakuni Kameyama | ||
| 1978 | 6 | 1 | 127 | Evaluation of Hypnotics and Sedative by National Institute of Drug Abuse(USA) | Controller Committee | ||
| 1978 | 6 | 1 | 127 | Evaluation of Hypnotics and Sedatives by National Institute of Drug Abuse (USA) | National Institute on Drug Abuse (NIDA) |
Controller Committee | |
| 1979 | 7 | 2 | 399 | Obligations of Clinical Investigators of regulated articles | FDA | Controller Committee | Federal Resister, Aug.8,1978 |
| 1979 | 7 | 2 | 413 | General Considerations for the Clinical Evaluation of Drugs | FDA | ||
| 1980 | 8 | 1 | 279 | Guidelines for Clinical Trials of Psychotropic Drugs | J.R.Wittenborn ed. | Hitoshi Itoh | |
| 1981 | 9 | 1 | 229 | Glossary for FDA Guidelines | Controller Committee | ||
| 1983 | 11 | 3 | 791 | Development and Approval of Drugs of Foreign Origin in Japan | Naokata Shimizu | ||
| 1984 | 12 | 2 | 557 | The International Regulatory Acceptability of Clinical Trials | Chikayuki N.,Schaus J., Baumelou A., Bilstad M, |
Controller Committee | |
| 1984 | 12 | 2 | 569 | International Regulatory Comparisons | Dukes M.N.G., Wardell W.M., Parker J.M., Hass A.E. |
Controller Committee | |
| 1986 | 14 | 4 | 907 | Draft Guideline for the Format and Content of the Clinical Data of an Application | FDA | Controller Committee | FDA Guideline Draft, Jan.1986 |
| 1987 | 15 | 3 | 601 | New Drug, Antibiotic, and Biologic Drug Product Regulation－IND Rewrite of FDA－ | FDA | Controller Committee | |
| 1989 | 17 | 1 | 141 | Recommended Basis for the Conduct of Clinical Trials of Medicinal Products in the European Community | CPMP Working Party on Efficacy of Drugs |
Controller Committee | |
| 1989 | 17 | 1 | 155 | Guidelines on Good Clinical Research Practice | ABPI | Controller Committee | |
| 1989 | 17 | 2 | 323 | Japanese Good Clinical Practice | Ministry of Health and Welfare | ||
| 1990 | 18 | 1 | 159 | Japanese Good Clinical Practice | Ministry of Health and Welfare | ||
| 1990 | 18 | 1 | 169 | Manual of Japanese Good Clinical Practice | Ministry of Health and Welfare | ||
| 1990 | 18 | 1 | 195 | The Implication and the Importance of Post-marketing Surveillance in Drug Evaluation | Ministry of Health and Welfare | ||
| 1990 | 18 | 1 | 197 | Method of the Investigation of the Results of Clinical Experience with Drugs 1987 | Ministry of Health and Welfare | ||
| 1990 | 18 | 1 | 205 | Method of the Investigation of the Results of Clinical Experience with Drugs 1988 | Ministry of Health and Welfare | ||
| 1990 | 18 | 1 | 217 | Method of the Investigation of the Results of Clinical Experience with Drugs 1989 | Ministry of Health and Welfare | ||
| 1990 | 18 | 2 | 381 | Good Clinical Practice for Trials on Medicinal Products in the European Community | CPMP Working Party on Efficacy of Medicinal Produc |
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| 1990 | 18 | 3 | 481 | FDA Approval Requirments for Lipid-Altering Agents | FDA | Controller Committee | |
| 1990 | 18 | 3 | 483 | Study Design and FDA Approval Requirements for Cancer Drugs | FDA | Controller Committee | |
| 1990 | 18 | 3 | 485 | International Adverse Drug Reporting | CIOMS | Controller Committee | |
| 1990 | 18 | 3 | 491 | A Brief Introduction for Good Clinical Practice for Trials on Drugs(Good Clinical Practice:GCP) | Tatsuo Kurokawa (Ministry of Health and Welfare) |
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| 1990 | 18 | 3 | 497 | Good Clinical Practice for Trials on Drugs(Notification) | Ministry of Health and Welfare | ||
| 1990 | 18 | 3 | 513 | Manual of Good Clinical Practice for Trials on Drugs(GCP) | |||
| 1990 | 18 | 3 | 543 | Good Clinical Practice for Trials on Medicinal Products in the European Community: Addition and Alteration | |||
| 1991 | 19 | 1 | 165 | AmFAR AIDS/HIV Clinical Trial Handbook | AmFAR | Akiea Sakuma | |
| 1991 | 19 | 1 | 173 | What Are Clinical Trial All About?－A Booklet for Patients with Cancer－ | Eleanor Nealon, NCI | Akira Sakuma | |
| 1991 | 19 | 2 | 277 | Standard for Implementation of the Post-Marketing Surveillance for the Reexamination Applications of New Drugs, etc.(Notification) | Ministry of Health and Welfare | ||
| 1991 | 19 | 2 | 291 | Research Report from the Task Force on an Implementation Method of the Investigation of the Results of Clinical Experience with Drugs; 1990 | Ministry of Health and Welfare | ||
| 1991 | 19 | 3 | 413 | EC Guideline－Clinical Investigation of Medicinal Products in the Elderly | Keiji Ueda | EC Guideline | |
| 1991 | 19 | 3 | 417 | FDA Guideline－Guideline for the Study of Drugs Likely to be Used in the Elderly | Keiji Ueda | FDA Guideline | |
| 1992 | 20 | 1 | 205 | Guidelines Concerning Statistical Analysis of Controlled Clinical Trials | Ministry of Health and Welfare | ||
| 1992 | 20 | 2 | 401 | General Consideration for the Clinical Evaluation of New Drugs | Ministry of Health and Welfare | ||
| 1992 | 20 | 3 | 543 | WHO Guidelines for Good Clinical Practice (GCP) for Trials on Pharmaceutical Products | Division of Drug Management & Policies WHO |
Keiji Ueda | WHO Guideline |
| 1992 | 20 | 3 | 563 | International Guigelines for Ethical Review of Epidemiological Studies | CIOMS Geneva | Tadahiro Mituishi | |
| 1993 | 21 | 1 | 129 | Government Viewpoint of Clinical Trials | Robert Temple, FDA | ||
| 1993 | 21 | 1 | 141 | Difficulties in Evaluating Positive Control Trials | Robert Temple, FDA | ||
| 1993 | 21 | 2 | 303 | Orphan Drugs Regulation: Final Rule | HHS，FDA | Yoshihito Omori | |
| 1993 | 21 | 3 | 499 | FDA Final Report of the Committee for Clinical Review Based on a Review of Selected Medical Device Applications | FDA | Yoshihito Omori | |
| 1994 | 22 | 1 | 175 | Medical Device Clinical Study Guidance | FDA | Yoshihito Omori | |
| 1994 | 22 | 2,3 | 261 | International Ethical Guidelines for Biomedical Research Involving Human Subjects | CIOMS | Tadahiro Mituishi | |
| 1995 | 23 | 1 | 121 | Guideline for the Study and Evaluation of Gender Difference in the Clinical Evaluation of Drugs | FDA | Naokata Shimizu, Toshio Watabe |
Federal Resister July 22,1993 |
| 1995 | 23 | 1 | 137 | Present Status of Compliance wtih GCP(Part1)－Results of Questionnaire to Medical Institutions－ | Keiji Ueda | ||
| 1995 | 23 | 2 | ICH・GCP Guideline and Addenda(Draft) | Ministry of Health and Welfare | |||
| 1995 | 23 | 3 | 631 | Present Status of Compliance with GCP(Part2)－Results of Questionnaire to Chief Investigators－ | Keiji Ueda | ||
| 1996 | 24 | 1 | 79 | New Analyses Regarding the Safety of Calcium-channel Blockers: A Statement for Health Professionals from the National Heart, Lung, and Blood Institute | NHLBI | ||
| 1996 | 24 | 1 | 85 | Yoshihiro Kaneko | |||
| 1996 | 24 | 1 | 87 | Prospective Randomized Open Blinded End-pont(PROBE) Study －A novel design for intervention trials－ | Lennart Hansson, et al. | Yoshihiro Kaneko | Blood Pressure, 1:113-119,1992 |
| 1996 | 24 | 1 | 95 | Yoshihiro Kaneko | |||
| 1996 | 24 | 1 | 97 | Studies On Improvement Of Package Insert | Naokata Shimizu | ||
| 1996 | 24 | 1 | 117 | Ministry of Health and Welfare | |||
| 1996 | 24 | 1 | 125 | Ministry of Health and Welfare | |||
| 1997 | 24 | 2,3 | 263 | A new proposal for benefit-less-risk analysis in clinical trials | Christy Chang-Stein, PhD. | Koichi Yamamoto | Controlled Clinical Trials,15:30-43, 1994 |
| 1997 | 24 | 2,3 | 275 | A new propozal for benefit-less-risk analysis in clinical traials | Christy Chang-Stein, PhD. | Akira Sakuma | 1994 |
| 1997 | 24 | 2,3 | 281 | comment | Koichi Yamamoto | ||
| 1997 | 24 | 2,3 | 285 | Studies on facilitation of voluntary reporting by health professions of adverse drug reactions in Japan | Naokata Shimizu, Yasuo Kozu, Toshitaka Nabeshima | ||
| 1998 | 26 | 1 | 89 | Guideline for Non-Clinical Safety Studies for the Conduct of Human Clinical Trials for Pharmaceuticals [Japanese][English] | |||
| 1998 | 26 | 1 | 109 | Genaral Considerations for Clinical Trials | |||
| 1998 | 26 | 2 | 285 | Guidelines for the Evaluation of Antidementia Drugs | FDA | Yoshihito Omori, Chieko Kurihara |
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| 1998 | 26 | 2 | 311 | Note for Guidance on Medicinal Products in the Treatment of Alzheimar's Disease | CPMP | Yoshihito Omori, Chieko Kurihara |
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| 1998 | 26 | 2 | 321 | Introduction of seven abstracts of Systematic Review of Antidementia Drugs in the Cochrane Database of Systematic Review | The Editorial Staff | ||
| 1999 | 26 | 3 | 505 | Conflict of Interest in the Debate over Calcium-Channel Antagonists | Henry T. Stelfox, M.D., Grace Chua, M.D., Keith O'Rourke, M.B.A., Allan S. Detsky, M.D.,Ph.D. |
Tadahiro Mitsuishi | N Engl J Med. 1998; 338:101-106 |
| 1999 | 26 | 3 | 517 | Ethnic Factors in the Acceptability of Foreign Clinical Data | Ministry of Health and Welfare | ||
| 1999 | 27 | 1 | 159 | Statistical Principles for Clinical Trials [Japanese][English] | Ministry of Health and Welfare | ||
| 1999 | 27 | 2 | 361 | The Report of the Committee on Appropriate Execution of Clinical Trials | |||
| 1999 | 27 | 2 | 371 | Impact of the New GCP Regulation on Clinical Trials in Japan -A Survey of IRB chairs- | Keiji Ueda, Shunichi Fukuhara, Peter L. Glickman, et al. |
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| 1999 | 27 | 2 | 379 | Survey of the Performance for Nurse Clinical Research Coordinator | Toshiko Ibe, Yasuko Tokunaga | ||
| 1999 | 27 | 2 | 393 | Medical Statistics as Viewed from the Perspective of Value of Information | Tenri Institute of Medical Research (Chief; Maetani S) | ||
| 1999 | 27 | 2 | 409 | Double-blind Trial of Intravenous and Subcutaneous Administrations of Recombinant Human Erythropoietin (SNB-5001) for Anemia in Hemodialysis Patients (Revised Article) | Shozo Koshikawa, Kazuo Ota, Yasushi Asano, et al. |
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| 2000 | 28 | 1 | 153 | Guidance for industry: Providing clinical evidence of effectiveness for human drug and biological products | FDA/CDER & FDA/CBER | Tsutani K, Usuki H | |
| 2001 | 28 | 3 | 527 | Declaration of Helsinki | World Medical Association | Japan Medical Association | |
| 2001 | 28 | 3 | 531 | Choice of control group in clinical trials | Notification from Evaluation and Licensing Division, Pharmceutical and Medical Safety Bureau, Ministry of Health, Labor and Welfare |
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| 2001 | 28 | 3 | 559 | The Belmont Report | The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research |
Tsutani K, Mitsuishi T, Kurihara C |
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| 2001 | 29 | 1 | 203 | Sponsorship, authorship, and accountability | Davidoff F, et al. | Kurihara C, Mitsuishi T |
NEJM 2001; 345: 825-7 |
| 2002 | 29 | 2･3 | 303 | Britain's gift: a "Medline" of synthesized evidence: Worldwide free access to evidence based resources could transform health care | Richard Smith, Iain Chalmers | Saio T | BMJ 2001; 323: 1437-8 |
| 2002 | 29 | 2･3 | 367 | Relation between clinical trial's process and compliance review | Editorial Committee | ||
| 2002 | 29 | 2･3 | 368 | Services concerning compliance review for new drugs of OSPR | Editorial Committee | ||
| 2002 | 30 | 1 | 135 | Code de la Sante Publique Premiere Parti, Livre Ier Titre II. Recherches biomedicales | Mitsuishi T, Nudeshima J, Kurihara C |
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| 2002 | 30 | 1 | 143 | Is the placebo powerless? An analysis of clinical trials comparing placebo with no treatment | Hrobjartsson A, Gotzsche PC | Kobayashi T, Kurihara C, Tsutani K |
NEJM 2001; 344(21): 1594-602 |
| 2002 | 30 | 1 | 159 | The powerful placebo and the wizard of Oz | John C. Bailar III | Kobayashi T, Kurihara C, Tsutani K |
NEJM 2001; 344(21): 1630-2 |
| 2002 | 30 | 1 | 163 | The revised CONSORT statement for reporting randomized trials: Explanation and elaboration | Altman DG, Schulz KF, Moher D, et al. |
Tsutani K, Kurihara C | Ann of Intern Med 2001; 134(8): 663-94 |
| 2003 | 30 | 2･3 | 397 | Report on the developments of the Dutch system for medical ethical review | Marcel JH Kenter | Uchida N, Uchida E | The EFGCP News |
| 2003 | 31 | 1 | 59 | The Committee Report on standard principle of the utilization of SMO | Ministry of Health, Labour and Welfare |
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| 2003 | 31 | 1 | 69 | Relation between CRO and SMO-Proper attitude of CRO and SMO- | Japanese CRO Association | ||
| 2003 | 31 | 1 | 75 | Ethical guidelines for clinical research | Ministry of Health, Labour and Welfare |
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| 2003 | 31 | 1 | 141 | The participant's continuing consent and the roles of doctors, sponsors, IRBs, and supporting organizations | Okamoto T, Kurihara C | ||
| 2003 | 31 | 1 | 145 | Consent for continuing research participation: What is it and when should it be obtained? | Dave Wendler, Jonathan Rackoff |
Okamoto T | IRB: Ethics & Human Research 2002; 24(3): 1-6 |
| 2003 | 31 | 1 | 153 | Explanation of the translation of the article "Standardized reporting of clinical practice guidelines" | Saio T, Mitsuishi T | ||
| 2003 | 31 | 1 | 157 | Standardized reporting of clinical practice guidelines: A proposal from the Conference on Guideline Standardization | Shiffman RN, Shekelle P, et al. |
Saio T, Mitsuishi T | Ann Intern Med 2003; 139: 493-8 |
| 2003 | 31 | 1 | 169 | Report on a study of the present status of unapproved drug use in Japan, including thalidomide | |||
| 2004 | 31 | 2 | 423 | Concerning legal control on medical research involving incapable adults in the Adults with Incapacity (Scotland) Act 2000 | Mitsuishi T | ||
| 2004 | 31 | 2 | 485 | Common Operational Guideline for the Ethical Review of Translational Research | Asano S, Iwamoto A, Tahara H, et al. |
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| 2004 | 31 | 3 | 629 | Is the ethical imperative of informing study participants of research results realized in Japan? | Okamoto T, Kurihara C | ||
| 2004 | 31 | 3 | 635 | Informing Study Participants of Research Results: An Ethical Imperative | Fernandez CV, Kodish E, Weijer C |
Okamoto T | IRB: Ethics & Human Research 2003; 25(3): 12-9 |
| 2004 | 31 | 3 | 647 | TREND statement: to promote evidence-based public health | Saio T, Fujita T | ||
| 2004 | 31 | 3 | 649 | Improving the reporting quality of nonrandomized evaluations of behavioral and public health interventions: the TREND statement | Des Jarlais DC, Lyles C, Crepaz N, the TREND group |
Saio T, Fujita T | AJPH 2004; 94(3): 361-6 |
| 2005 | 32 | 1 | 271 | Review: 2004 Revision of the French Human Research Participants Protection Act | Nudeshima J | ||
| 2005 | 32 | 1 | 285 | Code de la Sante Publique Premiere Parti, Livre Ier Titre II. Recherches biomedicales | Nudeshima J | ||
| 2005 | 32 | 1 | 297 | "Number needed to screen" as an application of the F method: understanding diverse indicators derived from "number needed to treat" | Saio T, Fujita T | ||
| 2005 | 32 | 1 | 301 | Number needed to screen: development of a statistic for disease screening | Rembold CM | Saio T, Fujita T | BMJ 1998; 317: 307-12 |
| 2005 | 32 | 1 | 311 | FDA Pharmacogenomics Guidance: Impact on drug development | Ronald A. Salerno | Azuma J, Katoh K | |
| 2005 | 32 | 2･3 | 513 | From translational research to critical path research | Murayama T | ||
| 2005 | 32 | 2･3 | 517 | Innovation・Stagnation －Challenge and opportunity on the critical path to new medical products－ | U.S. Department of Health and Human Services, Food and Drug Administration |
Nishikawa A, Asahara M, Murayama T, et al. |
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| 2005 | 32 | 2･3 | 543 | FDA Guidance for Industry "Pharmacogenomics Data Submission" and its collaterals －A Japanese translation | Azuma J, Quintiles Transnational Japan KK |
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| 2005 | 32 | 2･3 | 619 | Notification on the Pharmacogenomic Data Submissions | Ministry of Health, Labor and Welfare |
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| 2005 | 32 | 2･3 | 623 | Directive 2004/23/EC of the European Parliament and of the Council of 31 March 2004 on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells. | Yonemoto S | ||
| 2005 | 32 | 2･3 | 633 | New drugs for neglected diseases : From pipeline to patients | Bernard Pecoul | Hirabayashi F | |
| 2005 | 32 | 2･3 | 639 | Is this clinical trial fully registered ? : A Statement from the International Committee of Medical Journal Editors | De Angelis C, Drazen JM, Frizelle FA, et al. |
Saio T, Mitsuishi T, Fukushima M |
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| 2005 | 32 | 2･3 | 643 | Medical journals are an extension of the marketing arm of pharmaceutical companies | Richard Smith | Saio T, Mitsuishi T, Fukushima M |
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| 2005 | 33 | 1 | 259 | From philosophical psychopathology to positivistic psychometrics | Saio T | ||
| 2005 | 33 | 1 | 261 | The Dictionary of Disorder : how one man revolutionized psychiatry | Spiegel A | Saio T | |
| 2006 | 33 | 2 | 421 | Guidance on Central IRB by FDA : Explanatory overview | Kurihara C | ||
| 2006 | 33 | 2 | 425 | Guidance for industry Using a centralized IRB review process in multicenter clinical trials | Food and Drug Administration | Kurihara C, Saio T | |
| 2006 | 33 | 3 | 583 | Guidance for Industry, Investigators, and Reviewers Exploratory IND Studies | U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER) |
Nishikawa A, Murayama T, Kasai Y, et al. |
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| 2006 | 33 | 3 | 600 | Exploratory IND Studies : The Perspective from Academia | Murayama T | ||
| 2006 | 33 | 3 | 603 | Guidance for Industry INDs －Approaches to Complying with CGMP During Phase 1 | U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER) |
Ezoe S, Murayama T, Nishikawa A, et al. |
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| 2006 | 33 | 3 | 625 | CGMP regulation for translational research | Maekawa T | ||
| 2007 | 34 | 1 | 123 | Obstacles to Critical Path Research in Japan | Murayama T | ||
| 2007 | 34 | 1 | 127 | Innovation・Stagnation －Critical Path Opportunities Report－ | U.S. Department of Health and Human Services, Food and Drug Administration |
Nishikawa A, Murayama T | |
| 2007 | 34 | 1 | 155 | Innovation・Stagnation －Critical Path Opportunities List－ | U.S. Department of Health and Human Services, Food and Drug Administration |
Murayama T, Yokode M | |
| 2007 | 34 | 1 | 179 | The JSQA Guideline for GCP Auditing | JSQA, GCP Division, Special Project |
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| 2007 | 34 | 2 | 345 | Translation of EMEA/CHMP/96268/2005/Guideline on Risk Management Systems for Medicinal Products for Human | Barata K, Furukawa A, Ishida K, et al. |
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| 2007 | 34 | 2 | 347 | Guideline on Risk Management Systems for Medicinal Products for Human Use | Committee for Medicinal Products for Human Use (CHMP) |
Saio T, Kurihara C, Pharmacovigilance Working Group | |
| 2007 | 35 | 1 | 91 | Guidance for Industry Computerized Systems Used in Clinical Investigations | U.S. Department of Health and Human Services, Food and Drug Administration (FDA), Office of the Commissioner (OC) |
Nishikawa A, Yamamoto K, Fukushima M |
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| 2007 | 35 | 1 | 104 | Guidance for Industry Computerized Systems Used in Clinical Investigations | Yamamoto K, Fukushima M | ||
| 2007 | 35 | 1 | 107 | Guidance for Industry Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics | U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation andResearch (CDER), Center for Biologics Evaluation and Research (CBER) |
Nishikawa A, Murayama T, Kojima S, et al. |
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| 2007 | 35 | 1 | 128 | Selection of optimal endpoints for cancer clinical trials | Teramukai S, Fukushima M | ||
| 2007 | 35 | 1 | 131 | Guideline on strategies to identify and mitigate risks for first-in-human clinical trials with investigational medicinal products | European Medicines Agency (EMEA), Committee for Medicinal Products for Human Use (CHMP) |
Pharmacovigilance Working Group, Kobayashi K, et al. | |
| 2007 | 35 | 1 | 145 | On the EMEA Guideline on strategies to identify and mitigate risks for first-in-human clinical trials with investigational medicinal products －The impact of the TGN1412 issue | Matsumoto K, Unno T, Kobayashi K, et al. |
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| 2009 | 36 | 3 | 785 | Explanatory review of the FDA guidance on adverse event reporting to IRBs | Kurihara C | ||
| 2009 | 36 | 3 | 787 | Guidance for clinical investigators, sponsors, and IRBs Adverse event reporting to IRBs －Improving human subject protection | U.S. Department of Health and Human Services,Food and Drug Administration (FDA), Office of the Commissioner (OC), et al. |
Kurihara C | |
| 2012 | 39 | 3 | 563 | Global approach to accelerating medical research | Kush RD | ||
| 2017 | 45 | 1 | 21 | Proposals on “Clinical Research Implementation Standard” stipulated in Article 3 and other issues of the Draft Clinical Research Act submitted to the 190th Diet (Ordinary Session) | Pharmaceutical and Medical Device Regulatory Science Society of Japan | ||
| 2018 | 46 | 1 | 97 | WMA DECLARATION OF TAIPEI ON ETHICAL CONSIDERATIONS REGARDING HEALTH DATABASES AND BIOBANKS | World Medical Association Inc. | Japan Medical Association | |
| 2019 | 46 | 3･4 | 549 | Compensation for clinical trial related injury －Commentary for clinical trial of medical device－ |
The Japan Federation of Medical Devices Associations |
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| 2019 | 47 | sup36 | 90 | A Recommendation | Fukushima M | ||
| 2019 | 47 | sup36 | 131 | ECRIN data centre certification given to TRI | Translational Research Center for Medical Innovation, Foundation for Biomedical Research and Innovation at Kobe | ||
| 2019 | 47 | sup36 | 132 | Orphanet Japan Website: released at TRI | Translational Research Center for Medical Innovation, Foundation for Biomedical Research and Innovation at Kobe | ||
| 2022 | 50 | 2 | 255 | Petition to the mayor of Nagoya city: The three critical proposals for extension of healthy lifespan and substantial reduction of the number of people with long-term care needs | Arai H, Matsuo S, Maseki M, Hattori T, Nagai Y, Fujii S, Fukushima M |