Index Day reports (ADR)...59, 125

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1 Index 15-Day reports (ADR)...59, Day reports (ADR) Day reports (ADR)...59 ADR reporting system Reporting by pharmaceutical companies ADR Reporting System Reporting by MHLW Advanced Review with Electronic Data Promotion Group...8 Adverse Drug Reaction (ADR) and Infection Reporting...29 Age classification for pediatric use AIDS Research Center (NIID)...10 Approval and Licensed Data Required for Approval Applications...68 Approval and licenses Acceptance of foreign clinical trial data...72 Application forms...32 Data to be Attached to Approval Application...71 Approval and Licenses Approval Applications for Drugs Manufactured Overseas...42 Transfer of Marketing Approvals...42 Approval review...63 Approval System for Regenerative Medicine...40 Article 42 of the Pharmaceutical Affairs Law...45 Biological products...18 Biosimilar Products...41, 87 Biotechnological products...85 Blood and Blood Products Division (PFSB)...4 Brand names of prescriptions drugs bridging studies...72 Certificates Issued by MHLW...43 Classification of reexamination approval Clinical development/studies Phases of studies...79 Clinical Studies...78 Clinical study reports (FSR)...82 Codevelopment of Drugs...42 Combination Products...41 Commentaries on Precautions in package inserts Compliance and Narcotics Division (PFSB)...3 Compliance Reviews...64 Conditional Accelerated Approval System for Pharmaceuticals...40 Common Technical Document (CTD) CTD Module CTD Module 2: Data summaries...70 CTD Module 3: Quality...70 CTD Module 4: Nonclinical study reports...71 CTD Module 5: Clinical study reports...71 Development of New Drugs...56 Dissemination of drug information General Safety information Dissemination of information...29 Dissemination of information on adverse reactions to drugs Drug Master File (DMF)...23 Drug Abuse Control...31 Drug Development Process from Development to Approval...56 Drug Marketing Approvals...32 Drug pricing Drug Safety Update Drug Seller Licensing...23 Drugs Classification...17 Definition...17 Quality Standards Based on Notifications...46 Drugs for Pediatric Use...36 Drugs using materials of human or animal origin...86 Early post-marketing phase vigilance

2 Economic Affairs Division (HPB)...4 Electronic information dissemination Safety information Emergency safety information (Yellow letter) Entries for biological products Entry of generic drugs in the NHI price list GCP General requirements...83 General Affairs Division (PFSB)...2 GMP Compliance review...66 Global harmonization...67 GMP compliance inspection...66 Good Clinical Practice (GCP)...26 Good Laboratory Practice (GLP)...25 Good Laboratory Practice (GLP)...75 Good Manufacturing Practice (GMP)...22 Good Post-marketing Study Practice (GPMSP)...28 Good Vigilance Practice (GVP) Government Batch Test Quality of Drugs...46 GPMSP...28 GPSP Paper Compliance Review and On-site GPSP Surveys for Reexamination and Reevaluation GPSP Guidance-mandatory drugs...17 Guidelines Clinical evaluation...83 Nonclinical Studies...73 Guidelines Concerning Drug Approval Applications...72 Guidelines for bioequivalence Studies...77 Guidelines for General Pharmacological Studies...77 Guidelines for Pharmacokinetic Studies...77 Guidelines for Promoting Optimal Use...40 Guidelines for Stability Tests...74 Guidelines for Toxicity Tests...75 Guidelines on Physicochemical Properties, Specifications, and Tests Methods...73 GVP Health and Medical Services Law for the Aged Health insurance programs Health Policy Bureau (HPB)...4 History of health insurance programs Hokuriku Branch...9 ICH...88 Infectious Diseases Information Center (NIID)...10 Information for drugs which completed reexamination or reevaluation International Conference on Harmonization (ICH)...89 Interview advice meetings...60 Investigational product GMP...84 Investigational products Quality...79 Issues related to the use of determination of unapproved drugs and off-label use Japan Agency for Medical Research and Development (AMED)...9 Japanese Pharmacopoeia (JP)...43 Japanese Pharmacopoeia and Other Standards...43 Kansai Branch...8 Labeling and Package Inserts...24 Labeling of excipients Law Concerning Access to Information...30 Manufacturing Business and Accreditation License...20 Manufacturing/Marketing Approval Application with Electronic Data...34 Manufacturing/Marketing Approvals Manufacturing/Marketing License...19 Marketing Approval Review...32 Marketing Approvals...32 Medical benefits under NHI programs Medical Device Evaluation Division (PFSB)...2 Microdose studies...81 Ministry of Health, Labour and Welfare (MHLW) Organization and function...1 National Institute of Biomedical Innovation...9 National Institute of Health Sciences (Health Sciences)

3 National Institute of Infectious Diseases (NIID)...10 NHI price list NHI reimbursement of medical fees Nonclinical studies Requirements...78 Non-prescription drugs...18 Non-prescription Drugs...71 Office of Cellular and Tissue-based Products (PMDA)...7 Office of Chemical Safety (PFSB)...3 Office of Compliance and Standards (PMDA)...8 Office of Drug Induced Damages (PFSB)...2 Office of Generic Drugs (PMDA)...7 Office of in Vitro Diagnostics (PMDA)...7 Office of International Cooperation...8 Office of International Programs...8 Office of Manufacturing/Quality and Compliance (PMDA)...8 Office of Medical Devices I (PMDA)...7 Office of Medical Devices II (PMDA)...7 Office of Medical Devices III (PMDA)...7 Office of Medical Informatics and Epidemiology(PMDA)...8 Office of New Drug I (PMDA)...6 Office of New Drug II (PMDA)...6 Office of New Drug III (PMDA)...6 Office of New Drug IV (PMDA)...7 Office of New Drug V (PMDA)...7 Office of OTC/Quasi-drugs (PMDA)...7 Office of Review Administration (PMDA)...6 Office of Review Management (PMDA)...6 Office of Safety I (PMDA)...8 Office of Safety II (PMDA)...8 Office of Standards and Guidelines Development (PMDA)...6 Office of Vaccines and Blood Products (PMDA)...7 On-site reviews...65 Orphan Drugs...36 Outline of Pharmaceutical Regulations...17 Outline of prescription of drug information Package inserts Background Guidelines Headings and their sequence Information to supplement package inserts Non-prescription drugs Style and format Package Inserts in English Package inserts of guidance-mandatory drugs Packaging Strategy for World-first Products...38 Paper reviews...65 Patent System...30 Patient-requested Therapy System...27 Periodic infection reports for biological products Periodic safety reports Pharmaceutical Affairs and Food Sanitation Council (PAFSC)...9 Pharmaceutical and Medical Device Act...15 Pharmaceutical Evaluation Division (PFSB)...2 Pharmaceutical Interview Forms (IF) Pharmaceutical Laws...15 Pharmaceutical laws and regulations...15 Pharmaceutical Safety and Environmental Health Bureau (PSEHB)...2 Pharmaceutical Safety Division (PFSB)...3 Pharmaceutical Supervision...47 Pharmaceuticals and Medical Devices Agency, an Independent Administrative Organization...5 Pharmacological studies Requirements...79 Phase I of clinical studies...80 Phase II of clinical studies...80 Phase III of clinical studies...80 Phase IV of clinical studies...81 PMS Post-marketing surveillance (PMS) Precautions (package inserts) Prescription drugs...17 Prescription Drugs...71 Prevention of Medical Accidents...47 Pricing formula for reimbursement price revisions Priority Review System...35 Priority reviews...15 Procedures for Clinical Trials...57 Product Recalls...47 Proper Advertisement...25 Public disclosure of information on new drug development...88 Recent revisions of NHI price list Reevaluation...28 Reevaluation System Reexamination...28 Data and procedures Designated classifications

4 Designation of drugs System Regulations for Imported Drug Management and Quality Control...67 Regulatory Science Strategy Consultations for Regenerative Medicine Products...39 Reimbursement prices for new drugs Research and Development Division (HPB)...4 Restrictive Approval System...36 Risk Management Plan...29 Risk management plan (RMP) Safety flash report ( Safety information Reporting System by Medical Personnel Safety Measures against Bovine Spongiform Encephalitis (BSE)...48 Safety monitoring During clinical studies...59 Safety studies Requirements...79 SOP for PMS Special populations...81 Specified biological products...18 Standards for Biological Materials...45 Structure and Layout of Package Insert for Prescription Drugs Studies of drug interactions...81 Studies of drug metabolites...81 Trial Conducted from a Compassionate Viewpoint (expanded trial)...27 Unapproved Drugs and Drugs of Off-label Use...37 WHO safety monitoring program Yellow letter

5 Participating Company List Under the supervision of Ministry of Health Labour and Welfare Japan, this publication has been updated regularly with the cooperation of the enthusiastic editors below. Leader: Katsunori KURUSU (Chapter 1) (Chapter 2) (Chapter 3) (Chapter 4) (Chapter 5) Sanofi KK Eisai Co, Ltd EA Pharma Co, Ltd Takeda Pharmaceutical Company Limited Daiichi Sankyo Co, Ltd Janssen Pharmaceutical KK MSD KK UCB Japan Co, Ltd Mitsubishi Tanabe Pharma Corporation Shionogi & Co, Ltd Kyowa Hakko Kirin Co, Ltd Chugai Pharmaceutical Co, Ltd Diabetes & Cardiovascular Regulatory Affairs Oncology & Immunology 2 Regulatory Affairs: Katsunori KURUSU Japan Regulatory Affairs: Michiyuki SUZUKI Regulatory Affairs: Tsuyoshi KOBAYASHI Regulatory Affairs: Katsunori INUI New Drug Regulatory Affairs: Yoshiyuki HATTORI Regulatory Development Department: Taihei SHIRASAKA Regulatory Policy & Intelligence: Kanji HIRAI, Jun ONO Regulatory Affairs: Yasuhiro HASEGAWA Regulatory Affairs: Mamoru IKEDA Regulatory Affairs: Kazuyo MARUCHI PV Operations Department: Hiroyuki OHTSUKA Regulatory Intelligence & Management Department: Yuichi TAKIDO, Yasuhiro KITSUTA (Chapter 6) Otsuka Pharmaceutical Co, Ltd Regulatory Affairs Department: Toshio SATO Contact: JAPAN PHARMACEUTICAL MANUFACTURERS ASSOCIATION Office of International Affairs Administrative Office Nihonbashi-Honcho, Chuo-ku, Tokyo , Japan address: jpma.or.jp Phone 81-3 (3241) 0326 Fax 81-3 (3242)