Japanese Pharmaceutical Affairs Authorities Regulatory Documents - May 2003 Full List Single User License - TABLE OF CONTENTS I. CABINET II. REGULATORY DOCUMENTS FROM THE MINISTRY OF HEALTH, LABOR AND WELFARE (MHLW) AND THE AFFILIATED STRUCTURES III. REGULATORY DOCUMENTS FROM OTHER AUTHORITIES IV. DOCUMENTS FROM INDUSTRY GROUPS V. MISCELLANEOUS Note concerning the translation of the titles I. CABINET Laws, Orders and Notifications Issuer - Date - Title * Law No. 49 (May 28, 2003) - Law which revises a part of Law Concerning Examination and Regulation of Manufacture, etc. of Chemical Substances * Law No. 48 (May 29, 2003) - Food Safety Basic Law * Law No. 45 (May 29, 2003) - Law which revises a part of the Act for the Prevention of Unreasonable Premiums and Misrepresentation Concerning Products and Services * Cabinet Office Notification No. 41, 42, 43, 44 (May 6, 2003) - The order authorizing the plan for special zone under the structural reforms [related law 20030278] Orders and Notifications Cabinet The executive branch of the Government of Japan Cabinet Office Coordinate the Cabinet and supports the Prime Minister The highest level administrative documents issued by the Prime Minister II. REGULATORY DOCUMENTS FROM THE MINISTRY OF HEALTH, LABOR AND WELFARE (MHLW) AND THE AFFILIATED STRUCTURES Ordinances, Notifications and Notices Issuer - Date - Title Minister of Health, Labor and Welfare * MHLW Ordinance No. 86 (May 6, 2003) - Health regime enforcement regulations [related law 20020935] * MHLW Ordinance No. 89 (May 15, 2003) - Ministerial ordinance revising partially the Enforcement Regulations of the Pharmaceutical Affairs Law [related law 20020631] * MHLW Ordinance No. 92 (May 20, 2003) - Partial revision of the ministerial ordinance on the pharmacy manufacturing equipment [related law 20020631] * MHLW Ordinance No. 93 (May 20, 2003) - Amendment of the Article 1, Paragraph 2, Item 2(1) of the Enforcement Regulations of the Pharmaceutical Affairs Law for manufacturing of a product in two or more factories in relation with the revised ministerial ordinance on GMP [related law 20020631 and revised ministerial ordinance 00940324] Ordinances Notifications Communications Bureaus of the MHLW PFSB: Pharmaceutical and Food Safety Bureau HPB: Health Policy Bureau HIB: Health Insurance Bureau HSB: Health Service Bureau LSB: Labor Standards Bureau ESB: Employment Security Bureau Divisions of PFSB GA: General Affairs Division ELD: Evaluation and Licensing Division SD: Safety Division ND: Compliance and Narcotics Division BBPD: Blood and Blood Products Division FSD: Food Sanitation Department The highest level administrative documents issued only by the Minister of Health, Labor and Welfare REGULATORY DOCUMENTS FROM THE MINISTRY OF HEALTH, LABOR AND WELFARE (MHLW) AND THE AFFILIATED STRUCTURES (CONT.) * MHLW Ordinance No. 94 (May 20, 2003) - Ministerial ordinance revising manufacturing and quality controls for medical devices [related law 20020631 and revised ministerial ordinance 00950437] * MHLW Ordinance No. 95 (May 20, 2003) - Ministerial ordinance revising manufacturing and quality controls for medicines and quasi-medicines (quasi-drugs) [related law 20020631 and revised ministerial ordinance 00990196] * MHLW Ordinance No. 96 (May 20, 2003) - Ministerial ordinance revising manufacturing and quality controls for imported medical devices [related law 20020631 and revised ministerial ordinance 0090486] * MHLW Ordinance No. 97 (May 20, 2003) - Ministerial ordinance revising manufacturing and quality controls for imported medicines and quasi-medicines (quasi-drugs) [related law 20020631 and revised ministerial ordinance 00990485] * MHLW Notification No. 195 (May 6, 2003) - A policy document defining the comprehensive plan for the promotion of the national health [related law 20020935] * MHLW Notification No. 205 (May 15, 2003) - Amendment of the list of the medicinal products specified by the Minister of Health, Labor and Welfare based on the Article 15, Paragraph 2, Items 2(2) and 2(5) of the Enforcement Regulations of the Pharmaceutical Affairs Law [related revised ministerial notification 00950032] * MHLW Notification No. 206 (May 15, 2003) - Amendment of the list of the medical devices specified by the Minister of Health, Labor and Welfare based on the Article 15, Paragraph 2, Items 2 of the Enforcement Regulations of the Pharmaceutical Affairs Law [related law 20020631 and revised ministerial notification 20010350] * MHLW Notification No. 207 (May 19, 2003) - A policy document defining the basic plan for assurance of safety blood products and stable blood supply [related law 20020631] * MHLW Notification No. 209 (May 20, 2003) - A policy document defining the animal products and specified by the Minister of Health, Labor and Welfare products of animal origin [related law 20020631] * MHLW Notification No. 210 (May 20, 2003) -A policy document defining the standards for materials of animal origin [related law 20020631] and [abolished notification 20010348] * MHLW Notification No. 211 (May 20, 2003) - Partial revision of the standards for biological preparations [related law 20020631 and ministerial notification 20030545] and [revised notification 00931133] * MHLW Notification No. 212 (May 20, 2003) - Partial revision of the medical devices specified under the Article 63, Paragraph 2 of the Pharmaceutical Affairs Law [related law 20020631 and ministerial notification 20030544] * MHLW Notification No. 213 (May 20, 2003) - Abolishment of medicinal products specified by the Minister of Health, Labor and Welfare under the Article 11, Paragraph 3, Item 1 of the Enforcement Regulations of the Pharmaceutical Affairs Law [related law 20020631 and ministerial ordinance 20030515] and [abolished notification 20020072] * MHLW/HIB Notification No. 0521001 (May 26, 2003) - Consultation document Director-General of the Pharmaceutical and Food Safety Bureau * PFSB Notification No. 0425005 (May 2, 2003) - Guidance for the enterprises not responded to the notice of the PFSB Notification No. 1314 Ministry of Health and Welfare Pharmaceutical and Food Safety Bureau Director-General of December 26, 2000 [related communication 20010001] * PFSB Notification No. 0515001 (May 15, 2003) - On the extension of the period for the examination of new medicinal products [revised notice 00980438] * PFSB Notification No. 0515005 (May 16, 2003) - Items which should be included in the package leaflet of products of animal origin [related law 20020631, ministerial ordinance 20030515, notices 00970372-374, 00990040-42, and 20011134-36] * PFSB Notification No. 0515008 (May 16, 2003) - On the periodic report system for infectious contamination of medicinal products of animal origin [related law 20020631] * PFSB Notification No. 05150011/ PFSB Notification No. 05150012 (May 16, 2003) - On the explanation to the investigation subjects about the effect of the use of certain products of animal origin and on the recording and keeping the record for the use of certain products of animal origin [related law 20020631 and ministerial ordinance 20030515] * PFSB Notification No. 05150014 (May 16, 2003) - About the enforcement of a legislation for establishment of reporting by the medical institutions of side effects, infections and complications related to medicines and medical devices [related law 20020631 and abolished notice 00970420] * PFSB Notification No. 05150017 (May 16, 2003) - Partial revision of the Pharmaceutical Affairs Law and Enforcement Regulations of the Pharmaceutical Affairs Law in relation to the rule for blood donation and blood collection [related law 20020631, government ordinances 20030439 and 20030440, ministerial ordinance 20030515, notifications 20030520 and 20030521, and notice 20020636] * PFSB Notification No. 0515020 (May 20, 2003) - About the indication concerning the name of the blood-originating country and a blood-drawing method [related law 20020631 and ministerial ordinances 20030515, 00950437 and 00990485] * PFSB Notification No. 0515024 (May 20, 2003) - The definition and views on the "voluntarily gratis blood donation" in Japan [related law 20020631 and notice 20030558] * PFSB Notification No. 0520001 (May 21, 2003) - About the products of animal origin, designation of specific products of animal origin and the establishment of standards for the products of animal origin [related law 20020631 and ministerial notifications 20030554-546] [revised notice 20010384] * PFSB Notification No. 0520004 (May 22, 2003) - Partial revision of the ministerial ordinance on manufacture and quality control of medicines and quasi-medicines (quasi-drugs) (in relation with products of animal origin) [related law 20020631 and ministerial ordinances 20030538-543] * PFSB Notification No. 0522002 (May 26, 2003) - On the quality and safety assurance of the medicines and medical devices produced by using products from animal origin from Canadian cattle * PFSB Notification No. 0523001 (May 28, 2003) - About improvement of safety of human-blood-based manufactured blood products and human-blood-based manufactured blood substitute medicinal products and establishment of the eighth basic policy plan to secure the stability supply [related law 20020631 and ministerial notification 20030537] * PFSB Notification No. 0416003 (May 30, 2003) - About the enforcement in the 2003 fiscal year of the "Blood Charity Exercise of Love" (a request) * PFSB Notification No. 377 (May 7, 2003) - Partial revision of the standards, such as for the structure, equipment, facilities, etc. for storage of toxic and deleterious substances [notice 20030491 and revised notice 20030493] * PFSB Notification No. 480 (May 7, 2003) - Standards, such as the structure, equipment, facilities, etc. for storage of toxic and deleterious substances: Part 2 (indoor tanks for storing non-solid substances); Part 3 (underground tanks) [related notice 20030491 and revised notice 20030495] * PFSB Notification No. 1175 (May 7, 2003) - Standards, such as the structure, equipment, facilities, etc. for storage of toxic and deleterious substances: Part 1 (outdoor tanks for storing non-solid substances) [revised notice 20030495] * PFSB Notification No. 1036 (May 7, 2003) - Guidance about the establishment of a toxic and deleterious substances surveillance indicator * PFSB Miscellaneous Communication (May 2, 2003) - Pharmaceuticals and Medical Devices Safety Information Bulletin No.188 [gefitinib, gatifloxacin hydrate] * PFSB Miscellaneous Communication (May 30, 2003) - Pharmaceuticals and Medical Devices Safety Information Bulletin No.189 [important information for infliximab （genetical recombination） 5 items] Heads of the Pharmaceutical and Food Safety Bureau Divisions * PFSB, Evaluation and Licensing Division Notification No. 0425001 / PFSB, Safety Division Notification No. 0425001 / MHLW, PFSB, Evaluation and Licensing Division Notification No. 0425002 / PFSB, Safety Division Notification No. 0425002 (May 2, 2003) - ICH E2C: Handling of supplementary clinical data concerning the periodic safety update reports for marketed medicinal products * PFSB, Evaluation and Licensing Division Notification No. 0520001 / PFSB, Safety Division Notification No. 0520001 / PFSB, Compliance and Narcotics Division Notification No. 0520001 / PFSB, Blood and Blood Products Division Notification No. 0520001 (May 21, 2003) - Transferring of the office responsibilities, etc. in relation with the partial revision of the Enforcement Regulations of the Pharmaceutical Affairs Law [related law 20020631, ministerial ordinance 20030515, notifications 20030544, 20030545, 20030520, and 20030548, and notices 20030563, 20030558, 20001212, 20010934, and 20010984] * PFSB, Evaluation and Licensing Division Notification No. 0516001 (May 16, 2003) - Scope of prescription medicinal products, which are required for submitting preliminary test results related to re-evaluation of quality (25th Round) (quality re-evaluation of generics) * PFSB, Evaluation and Licensing Division Notification No. 0514004 / PFSB, Evaluation and Licensing Division Notification No. 0514005 (May 19, 2003) - About the handling of Manufacture and Import Approval application for of HMG-CoA reducing enzyme inhibitors * PFSB, Evaluation and Licensing Division / Safety Division - Office Working Information (May 6, 2003) - About the safety measures for medicinal products and medical devices in relation with the Severe Acute Respiratory Syndrome, SARS (a notice concerning SARS) * PFSB, Evaluation and Licensing Division - Office Working Information (May 26, 2003) - About the products of animal origin and designation of products of animal origin [related law 20020631, ministerial notification 20030544, and notice 20030563] * PFSB, Evaluation and Licensing Division - Office Working Information (May 7, 2003) - Scope of prescription medicinal products, which are required for submitting preliminary test results related to re-evaluation of quality (No. 50) (Appendix) * PFSB, Evaluation and Licensing Division - Office Working Information (May 21, 2003) - Partial revision of the Pharmaceutical Affairs Law and Enforcement Regulations of the Pharmaceutical Affairs Law in relation to the rule for blood donation and blood collection (A Correction) [related law 20020631, and revised notice 20030535] * PFSB, Evaluation and Licensing Division - Office Working Information (May 12, 2003) - The 14th Edition of the Japanese Pharmacopoeia - Annex No. 1 (A Correction) [revised notice 20021173] * PFSB, Evaluation and Licensing Division - Office Working Information (May 16, 2003) - About investigation of application-for-approval items, such as new medicinal products * PFSB, Evaluation and Licensing Division - Office Working Information (May 12, 2003) - About the correction of the notice for a partial revision of the medicinal products standard 2002 outside of the Japanese Pharmacopoeia, and of the herbal medicine standard 1989 outside a Japanese Pharmacopoeia (A Correction) [revised notice 20021176] * PFSB, Evaluation and Licensing Division/Labor Standards Bureau, Industrial Safety and Health Department, Chemical Substances Investigation Division Notification No. 0520005 (May 26, 2003) - Guidance for the providers training the handlers of occupational hazardous materials such as formalin and other poisonous and deleterious substances * PFSB, Evaluation and Licensing Division - Miscellaneous Communication (May 15, 2003) - About the new priority publication items toward the 15th edition of the Japanese Pharmacopoeia * MHLW, PFSB, Evaluation and Licensing Division / Ministry of Economy, Trade and Industry, Manufacture Industrial Office, Chemical Substance Administration Division / Ministry of Environment, General Environment Policy Office, Environmental Health Department, General Planning and Policy Division - Miscellaneous Communication (May 6, 2003) - About the manufacture and import notification of new chemical entities * MHLW, PFSB, Evaluation and Licensing Division / Ministry of Economy, Trade and Industry, Manufacture Industrial Office, Chemical Substance Administration Division / Ministry of Environment, General Environment Policy Office, Environmental Health Department, General Planning and Policy Division - Miscellaneous Communication (May 6, 2003) - About the proposal procedure for a small quantity of new chemical entity * PFSB, Safety Division Notification No. 0428002 / Safety Division Notification No. 0428001 (May 7, 2003) - Revisions of the cautions for use of a medicinal product (A Notice) [gefitinib] * PFSB, Safety Division Notification No. 0509001 (May 12, 2003) - About the thoroughness of intra-hospital infection prevention measures against "Severe Acute Respiratory Syndrome" with unknown cause [related notices on SARS] * PFSB, Safety Division Notification No. 0430001 / Safety Division Notification No. 0430002 (May 13, 2003) - Revisions of the cautions for use of a medicinal product (A Notice) [lithium carbonate, pazufloxacin mesilate] * PFSB, Safety Division Notification No. 0512001 / PFSB, Evaluation and Licensing Division Notification No. 0512001 (May 14, 2003) - Points to pay attention regarding the individual case safety reports for medicinal products [related notices 20030004, 20010409-411] * PFSB, Safety Division Notification No. 0515001 (May 21, 2003) - About independent check of medical endoscopes, etc. * PFSB, Safety Division Notification No. 0520004 (May 26, 2003) - About the statements in the package inserts of products of animal origin [related law 20020631 and notice 20030531] * PFSB, Safety Division Notification No. 0526001 (May 26, 2003) - About independent check of combined use of medicinal products and medical devices made from polycarbonate [related notice 20020991] * PFSB, Safety Division Notification No. 66 (May 26, 2003) - Standards, such as the structure, equipment, facilities, etc. for storage of toxic and deleterious substances: Part 1 (outdoor tanks for storing non-solid substances) [revised notice 20030494] [related notice 20030491] * PFSB, Safety Division Notification No. 77 (May 26, 2003) - Standards, such as the structure, equipment, facilities, etc. for storage of toxic and deleterious substances: Part 1 (outdoor tanks for storing non-solid substances); Part 2 (indoor tanks), Part Miscellaneous (underground tanks) [related notice 20030495 and revised notice 20030492] * PFSB, Safety Division - Office Working Information (May 13, 2003) - Revisions of the cautions for use of a medicinal product (A Notice) [human fibrinogen-thrombin, aprotinin, 10 items] * PFSB, Compliance and Narcotics Division Notification No. 0411004 (May 2, 2003) - On the analytical method for sibutramine [related notice 20030499] * PFSB, Compliance and Narcotics Division - Office Working Information (May 2, 2003) - On the analytical method for sibutramine [related notice 20030452] * PFSB, Compliance and Narcotics Division Notification No. 0411003 (May 9, 2003) - O * PFSB, Compliance and Narcotics Division Notification No. 0411004 (May 2, 2003) - About the results of investigations on purchases, such as non-recognized in 2002 fiscal year unauthorized medicinal products * PFSB, Compliance and Narcotics Division - Office Working Information (May 20, 2003) - About the rapid analytical methods for medicinal products * PFSB, Compliance and Narcotics Division Notification No. 0424002 (May 20, 2003) - About the rapid analytical methods for medicinal products [final revision of Office Working Information 20030577] * PFSB, Blood and Blood Products Division Notification No. 0520006 (May 26, 2003) - About the response based on the WHO advice on the Severe Acute Respiratory Syndrome (SARS) [related notices on SARS] * PFSB, Blood and Blood Products Division Notification No. 0527003 (May 29, 2003) - About the safety assurance of blood products in relation with SARS [related notices on SARS] * PFSB, General Affairs Division Notification No. 0521001 / Ministry of Health, Labor and Welfare Notification / PFSB Notification No. 05021060 (May 26, 2003) About the enforcement of "Drugs and Health Week" * PFSB, General Affairs Division - Miscellaneous Communication (May 26, 2003) On the outline of 27th MOSS Follow-up Meeting * PFSB, Food Safety Department, Standards Division - Miscellaneous Communication (May 29, 2003) Joint sectional meeting of the Subcommittees on Toxicity and on Additives to the Pharmaceutical Affairs and Food Hygiene Council - outline of the examination result about specification of food additives, etc. * Health Services Bureau, Tuberculosis and Infectious Diseases Control Division Notification No. 0423002 (May 7, 2003) About the response to the mass outbreak of the Severe Acute Respiratory Syndrome (SARS) in Hanoi, Honk Kong, etc. (9th news release) [related notices on SARS] * Health Services Bureau, Tuberculosis and Infectious Diseases Control Division Notification No. 0501001 (May 7, 2003) About the response to the mass outbreak of the Severe Acute Respiratory Syndrome (SARS) in Honk Kong, etc. (10th news release) [related notices on SARS] * Health Services Bureau, Tuberculosis and Infectious Diseases Control Division Notification No. 0501002 (May 7, 2003) About the response by the quarantine stations to the Severe Acute Respiratory Syndrome (SARS) [related notices on SARS] * Health Services Bureau, Tuberculosis and Infectious Diseases Control Division Notification No. 0502001 (May 7, 2003) About the response to the mass outbreak of the Severe Acute Respiratory Syndrome (SARS) in Honk Kong, etc. (11th news release) [related notices on SARS] * Health Services Bureau, Tuberculosis and Infectious Diseases Control Division - Office Working Information (May 7, 2003) About the response by the quarantine stations to the Severe Acute Respiratory Syndrome (SARS) [related notices on SARS] * Health Services Bureau, Tuberculosis and Infectious Diseases Control Division Notification No. 0507001 (May 9, 2003) About the response by the quarantine stations to the Severe Acute Respiratory Syndrome (SARS) [related notices on SARS] * Health Services Bureau, Tuberculosis and Infectious Diseases Control Division Notification No. 0507003 (May 9, 2003) About the response to the mass outbreak of the Severe Acute Respiratory Syndrome (SARS) in Honk Kong, etc. (12th news release) [related notices on SARS] * Health Services Bureau, Tuberculosis and Infectious Diseases Control Division Notification No. 0508002 (May 12, 2003) About the enforcement of the revision of the definition and the administration of tests for the corona virus accompanying SARS (13th news release on the measures against SARS) [related notices on SARS] * Health Services Bureau, Tuberculosis and Infectious Diseases Control Division - Office Working Information (May 20, 2003) About the administration test point of a SARS corona virus (13th news release on the measures against SARS) [related notices on SARS] * Health Services Bureau, Tuberculosis and Infectious Diseases Control Division Notification No. 0516001 (May 20, 2003) About the reporting style for "doubtful case" and for "possible case" of SARS (14th news release on the measures against SARS) [related notices on SARS] * Health Services Bureau, Tuberculosis and Infectious Diseases Control Division Notification No. 0516002 (May 20, 2003) About the medical examination at early stage of a person suspected of having SARS (15th news release on the measures against SARS) [related notices on SARS] * Health Services Bureau, Tuberculosis and Infectious Diseases Control Division Notification No. 0518001 (May 20, 2003) About the travel information regarding Severe Acute Respiratory Syndrome (SARS) (16th news release on the measures against SARS) [related notices on SARS] * Health Services Bureau, Tuberculosis and Infectious Diseases Control Division Notification No. 051900 (May 20, 2003) About the response by the quarantine stations to the Severe Acute Respiratory Syndrome (SARS) [related notices on SARS] * Health Services Bureau, Specific Diseases Control Division Notification No. 0519001 / Health Services Bureau, Tuberculosis and Infectious Diseases Control Division Notification No. 0519002 (May 20, 2003) About the response to the Severe Acute Respiratory Syndrome (SARS) in the hotel business [related notices on SARS] * Health Services Bureau, Tuberculosis and Infectious Diseases Control Division Notification No. 0521001 (May 26, 2003) About the travel information regarding Severe Acute Respiratory Syndrome (SARS) (17th news release on the measures against SARS) [related notices on SARS] * Health Services Bureau, Specific Disease Control Division Notification No. 0527001 / Health Services Bureau, Tuberculosis and Infectious Diseases Control Division Notification No. 0527001 / PFSB, Blood and Blood Products Division Notification No. 0527002 (May 29, 2003) About blood in epidemiological surveys and confirmation of donation history of the internal organs in relation to SARS [related notices on SARS] * Health Services Bureau, Tuberculosis and Infectious Diseases Control Division Notification No. 0526001 (May 29, 2003) About the response by the quarantine stations to the Severe Acute Respiratory Syndrome (SARS) [related notices on SARS] * Health Services Bureau, Specific Disease Control Division Notification No. 0519001 (May 20, 2003) About the response to the Severe Acute Respiratory Syndrome (SARS) in the organ transplants and a hematogenous stem cell transplants [related notices on SARS] * Health Services Bureau, Tuberculosis and Infectious Diseases Control Division Notification No. 0523001 (May 29, 2003) About the travel information regarding Severe Acute Respiratory Syndrome (SARS) (18th news release on the measures against SARS) [related notices on SARS] * Health Services Bureau, Tuberculosis and Infectious Diseases Control Division Notification No. 0526003 (May 29, 2003) About the measures against SARS (Response to the finding of a corona virus similar to SARS virus in a wild animal in China) (19th news release on the measures against SARS) [related notices on SARS] * Health Insurance Bureau, Medical Economics Division - Office Working Information (May 6, 2003) About the calculation of the charges for chronic sharp pain disease management etc. [related notices 20020224-20020231] * Health Insurance Bureau, Medical Economics Division - Office Working Information (May 7, 2003) About dispatch of a doubt interpretation document [related notification 20030253 and notice 20030261] * Health Insurance Bureau, Medical Economics Division - Office Working Information (May 9, 2003) Survey of the medicinal products manufacturing (import) expenditures classified by all prefectures (as of September 2002) * Health Insurance Bureau, Medical Economics Division - Miscellaneous Communication (May 13, 2003) Medicinal products industrial survey report (medicinal products manufacturing industry and wholesale business) [2001 fiscal year] * Health Insurance Bureau, Medical Economics Division Notification No. 0515001 (May 20, 2003) About the quantity of the inventory of crude drugs under the Washington Convention (a request) [submission until June 20 to the Medical Economics Division] * Health Insurance Bureau, Medical Economics Division - Office Working Information (May 26, 2003) Survey of the medicinal products manufacturing (import) expenditures classified by all prefectures (as of October 2002) * Health Insurance Bureau, Medical Economics Division Notification No. 0529001 (May 29, 2003) About partial revision of a medical examination and treatment fee list and operational points of concern regarding the revision of medical examination and treatment fee list for the elderly (a Notice) [amended notice 20020225] [related notifications 20030643-645] * Health Insurance Bureau, Medical Economics Division Notification No. 0529002 (May 29, 2003) About the partial revision of the "statement points of medical examination and treatment fee bills" (a Notice) * Health Policy Bureau Notification No. 0430003 (May 23, 2003) About the establishment of the medical care safety support center * Health Policy Bureau, Research and Development Division / Ministry of Education, Culture, Sports, Science and Technology, Higher Education Bureau, Medical Education Division - Miscellaneous Communication (May 1, 2003) About the "National 3-year Clinical Trials Revitalization Plan" * Health Policy Bureau, Research and Development Division - Office Working Information (May 2, 2003) About the decision on the "National 3-year Clinical Trials Revitalization Plan" * Employment Security Bureau - Miscellaneous Communication (May 6, 2003) About the establishment of a fair employment system * MHLW, Study Group on the Reforms of the Healthcare System - Miscellaneous Communication (May 12, 2003) "The Study Group on the Reforms of the Healthcare System" Vision Plan (a conclusion) on the reforms of the healthcare system National Institute of Health Sciences * National Institute of Health Sciences Osaka branch office - Miscellaneous Communication (May 22, 2003) - MHLW Extramural Grant for Scientific Study on all Aspects of Drug Safety - Report: Introduction of the latest quality control techniques and a study generalization report about the improvement of the Japanese Pharmacopoeia to correspond to the revisions of the Pharmaceutical Affairs Law in term of quality [division input 1/3] * National Institute of Health Sciences Osaka branch office - Miscellaneous Communication (May 22, 2003) - MHLW Extramural Grant for Scientific Study on all Aspects of Drug Safety - Report: Enterprise allotment study report [division input 2/3] * National Institute of Health Sciences Osaka branch office - Miscellaneous Communication (May 22, 2003) - MHLW Extramural Grant for Scientific Study on all Aspects of Drug Safety - Report: Schedule about publication of study results [division input 3/3] * National Institute of Health Sciences - Miscellaneous Communication (May 22, 2003) - MHLW Extramural Grant for Scientific Study on all Aspects of Drug Safety - An enterprise allotment study report: A study about circumstances / techniques of the latest quality control system of medicinal products [division input 1/6] * National Institute of Health Sciences - Miscellaneous Communication (May 22, 2003) - MHLW Extramural Grant for Scientific Study on all Aspects of Drug Safety - An enterprise allotment study report: An ideal method of quality control system of medicinal products and a study about effective technique available [division input 2/6] * National Institute of Health Sciences - Miscellaneous Communication (May 22, 2003) - MHLW Extramural Grant for Scientific Study on all Aspects of Drug Safety - An enterprise allotment study report: The questionnaire on "Conditions of a quality examination room" used in the allotment study [division input 3/6] * National Institute of Health Sciences - Miscellaneous Communication (May 22, 2003) - MHLW Extramural Grant for Scientific Study on all Aspects of Drug Safety - An enterprise allotment study report: Overseas business trip report [division input 4/6] * National Institute of Health Sciences - Miscellaneous Communication (May 22, 2003) - MHLW Extramural Grant for Scientific Study on all Aspects of Drug Safety - An enterprise allotment study report: Research on the influence of the change of raw material affecting the quality of a medicinal products additives, and its measurement [division input 5/6] * National Institute of Health Sciences - Miscellaneous Communication (May 22, 2003) - MHLW Extramural Grant for Scientific Study on all Aspects of Drug Safety - An enterprise allotment study report: An indicator about GMP hardware corresponding to the factory for solid forms of medicinal products for internal use [division input 6/6] III. REGULATORY DOCUMENTS FROM OTHER AUTHORITIES Issuer - Date - Title * Special Committee on Drug Prices of the Central Social Insurance Medical Council - Miscellaneous Communication (May 7, 2003) - Proceedings of the 12th Meeting of the Special Committee on Drug Prices of the Central Social Insurance Medical Council * Special Committee on Drug Prices of the Central Social Insurance Medical Council - Miscellaneous Communication (May 7, 2003) - The outline of the standard for the price-of-medicine calculation * Special Committee on Drug Prices of the Central Social Insurance Medical Council - Miscellaneous Communication (May 7, 2003) - Price-of-medicine calculation rule related data * Special Committee on Drug Prices of the Central Social Insurance Medical Council - Miscellaneous Communication (May 7, 2003) - About advancing the examination of the future about a drug-price system Communications The highest level administrative documents issued by various authorities CSIMC Central Social Insurance Medical Council Ministries Ministry of Economy, Trade and Industry REGULATORY DOCUMENTS FROM OTHER AUTHORITIES (CONT.) * Special Committee on Drug Prices of the Central Social Insurance Medical Council - Miscellaneous Communication (May 30, 2003) - Special Committee on Drug Prices of the Central Social Insurance Medical Council proceedings outline (proposal) * Special Committee on Drug Prices of the Central Social Insurance Medical Council - Miscellaneous Communication (May 30, 2003) - Proceedings of the 12th Meeting of the Special Committee on Drug Prices of the Central Social Insurance Medical Council * Special Subcommittee on the Basic Problems of the Medical Treatment Fees of the Central Social Insurance Medical Council - Miscellaneous Communication (May 7, 2003) - About the introductory time of blanket evaluation of the advanced treatment hospitals * Special Subcommittee on the Basic Problems of the Medical Treatment Fees of the Central Social Insurance Medical Council - Miscellaneous Communication (May 7, 2003) - Proceeding of the 23rd Meeting of the Central Social Insurance Medical Council Medical treatment fee basic problem subcommittee * Special Subcommittee on the Basic Problems of the Medical Treatment Fees of the Central Social Insurance Medical Council - Miscellaneous Communication (May 7, 2003) - About the future examination subjects and the directivity of the examination * Special Subcommittee on the Basic Problems of the Medical Treatment Fees of the Central Social Insurance Medical Council - Miscellaneous Communication (May 16, 2003) - The Health Insurance Law, insurance medical institutions, and doctors accepting health insured patients -- the rule for medical treatment * Special Subcommittee on the Basic Problems of the Medical Treatment Fees of the Central Social Insurance Medical Council - Miscellaneous Communication (May 16, 2003) - The schedule of evaluation of ten hospital trial enterprises, such as blanket evaluation of advanced treatment hospitals and the National Hospitals, (proposal) * Special Subcommittee on the Basic Problems of the Medical Treatment Fees of the Central Social Insurance Medical Council - Miscellaneous Communication (May 16, 2003) - Outline of Special Healthcare Expenditures * Special Subcommittee on the Basic Problems of the Medical Treatment Fees of the Central Social Insurance Medical Council - Miscellaneous Communication (May 16, 2003) - Proceeding of the 25th Meeting of the Central Social Insurance Medical Council Medical treatment fee basic problem subcommittee * Special Subcommittee on the Basic Problems of the Medical Treatment Fees of the Central Social Insurance Medical Council - Miscellaneous Communication (May 16, 2003) - About the business for medical examination and treatment fee the special organization performs, and its management (proposal) * Special Subcommittee on the Basic Problems of the Medical Treatment Fees of the Central Social Insurance Medical Council - Miscellaneous Communication (May 16, 2003) - View about [Mixed medical examination and treatment] - (Japan Medical Association medical policy meeting) * Special Subcommittee on the Basic Problems of the Medical Treatment Fees of the Central Social Insurance Medical Council - Miscellaneous Communication (May 26, 2003) - Proceeding of the 26th Meeting of the Central Social Insurance Medical Council Medical treatment fee basic problem subcommittee * Special Subcommittee on the Basic Problems of the Medical Treatment Fees of the Central Social Insurance Medical Council - Miscellaneous Communication (May 26, 2003) - Reexamination of successive diminution systems, such as a charge of re-examination (proposal) * Special Subcommittee on the Basic Problems of the Medical Treatment Fees of the Central Social Insurance Medical Council - Miscellaneous Communication (May 26, 2003) - About the medical institution for data collection (proposal) * Special Subcommittee on the Basic Problems of the Medical Treatment Fees of the Central Social Insurance Medical Council - Miscellaneous Communication (May 26, 2003) - Revision of the Central Social Insurance Medical Council standing order (proposal) * Special Subcommittee on the Basic Problems of the Medical Treatment Fees of the Central Social Insurance Medical Council - Miscellaneous Communication (May 30, 2003) - An example of the present medical treatment fee mark which evaluated serious illness aggravation prevention and development of symptoms prevention * Special Subcommittee on the Basic Problems of the Medical Treatment Fees of the Central Social Insurance Medical Council - Miscellaneous Communication (May 30, 2003) - About revision of a high tech medical treatment system (proposal) * Special Subcommittee on the Basic Problems of the Medical Treatment Fees of the Central Social Insurance Medical Council - Miscellaneous Communication (May 30, 2003) - About the course of medical treatment which has an indication related insurance application * Special Subcommittee on the Basic Problems of the Medical Treatment Fees of the Central Social Insurance Medical Council - Miscellaneous Communication (May 30, 2003) - Proceeding of the 27th Meeting of the Central Social Insurance Medical Council Medical treatment fee basic problem subcommittee * Central Social Insurance Medical Council - Miscellaneous Communication (May 26, 2003) - Report of the Chairman of the Central Social Insurance Medical Council * Central Social Insurance Medical Council - Miscellaneous Communication (May 26, 2003) - New insurance application * Central Social Insurance Medical Council - Miscellaneous Communication (May 26, 2003) - About the main complaints from the patients brought near by the health insurance pharmacies (matter concerning the successive diminution system of a medical treatment fee and a dispensing fee), etc. * Central Social Insurance Medical Council - Miscellaneous Communication (May 26, 2003) - New medicinal products table (June 6, 2003 balance estimate) * Central Social Insurance Medical Council - Miscellaneous Communication (May 26, 2003) - Reexamination of successive diminution systems, such as the charge of the re-examination (proposal) * Central Social Insurance Medical Council - Miscellaneous Communication (May 26, 2003) - About the medical institution for data collection (proposal) * Central Social Insurance Medical Council - Miscellaneous Communication (May 26, 2003) - Revision of the Central Social Insurance Medical Council standing order (proposal) * Central Social Insurance Medical Council - Miscellaneous Communication (May 26, 2003) - About the examination matters related to the insurance medical materials system (proposal) * Central Social Insurance Medical Council - Miscellaneous Communication (May 26, 2003) - Proceeding of the 33rd General Meeting of the Central Social Insurance Medical Council * Sectional Meeting of the Committee on Handling the Information on Medical Treatment Errors - Miscellaneous Communication (May 19, 2003) - Proceedings of the 6th medical safety measures liaison conference * Study Meeting on the Status of the System for Providing Healthy Food - Miscellaneous Communication (May 30, 2003) - Second examination meeting about the Status of the System for Providing Healthy Food * Ministry of Economy, Trade and Industry Notification of May 9, 2003/ PFSB Notification No. 0526001 (May 9, 2003) - Request for cooperation for a power saving towards the summer * Ministry of Economy, Trade and Industry - Miscellaneous Communication (May 29, 2003) - Official announcement of report on the medical equipment industrial round-table conference * Secretariat of the Head Office for Judicial Reforms - Office Working Information (May 6, 2003) - About the collection of opinions regarding the intellectual property lawsuits (May 31 is the deadline for presenting intellectual property lawsuits opinions to the person in charge of collecting) IV. DOCUMENTS FROM INDUSTRY GROUPS Issuer - Date - Title * FPMAJ Rapid Communication No. 258 (May 6, 2003) - On the investigation of the corporate codes for agents such as tablets and capsules * FPMAJ Rapid Communication No. 316 (May 26, 2003) - On the guidance of the explanatory meeting about the independent check of combined use of medicinal products and the medical devices made from polycarbonate * FPMAJ Rapid Communication No. 577 (May 30, 2003) - A request about the date of enforcement of the Pharmaceutical Affairs Law regarding products from biological origin * FPMAJ Rapid Communication No. 651 (May 30, 2003) - A request document about the Cabinet Order related to the matters concerning an Amendments of the Pharmaceutical Affairs Law * FPMAJ Miscellaneous Communication (May 30, 2003) - A request about reexamination of a pharmaceutical affairs structures * JMA (May 26, 2003) - The state of medical treatment fees Communications FPMAJ Federation of Pharmaceutical Manufacturers' Associations of Japan JPMA Japan Pharmaceutical Manufacturers Association OPMA Osaka Pharmaceutical Manufacturers Association JMA Japan Medical Association The highest level administrative documents issued only by various industry associations and trade groups, and professional organization DOCUMENTS FROM INDUSTRY GROUPS (CONT.) * Society of Japanese Pharmacopoeia / Federation of Pharmaceutical Manufacturers' Associations of Japan - Miscellaneous Communication (May 26, 2003) - Drug Safety Update (DSU No. 119) - Guidance on the changes in cautions for prescription medicinal products * Osaka Pharmaceutical Manufacturers Association - Miscellaneous Communication (May 6, 2003) - Reference information regarding the newly approved medicinal products (Office Working Information dated April 16, 2003) [related Office Working Information 20030429] * Osaka Municipality - Miscellaneous Communication (May 6, 2003) - About the Osaka persons to be recognized for rendering distinguished pharmaceutical affairs related services by the governor commendation in the 2003 fiscal year (submission by June 24 to the Osaka Pharmaceutical Manufacturers Association) * Osaka Municipality Planning Coordination Department, Planning Coordination Division, General Coordination Section - Miscellaneous Communication (May 6, 2003) - The order authorizing the plan for special zone under the structural reforms [related law 20030278] V. MISCELLANEOUS Issuer - Date - Title * National Printing Bureau (Independent Administrative Agency) - Miscellaneous Communication (May 15, 2003) - Public announcement of the successful bidders of medicinal products * National Printing Bureau (Independent Administrative Agency) - Miscellaneous Communication (May 22, 2003) - Public announcement of the successful bidders of medicinal products * Drug Products Liability Center - Miscellaneous Communication (May 15, 2003) - Drug Products Liability Center FAX communication No. 85 * Drug Products Liability Center - Miscellaneous Communication (May 30, 2003) - Annual report for the 2002 fiscal year Communications Organizations National Printing Bureau Drug Products Liability Center The administrative documents issued by various organizations Note concerning the translation of the titles All original documents issued by the Japanese Government, other authorities and industry group are issued only in Japanese, including their titles, table of contents and texts. 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