Japanese Pharmaceutical Affairs Authorities Regulatory Documents - June 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. 55 (June 4, 2003) - Law which revises a part of Food Sanitation Law * Law No. 55 (June 4, 2003) - Law which revises a part of Food Sanitation Law * Law No. 56 (June 4, 2003) - Law which revises a part of Health Promotion Law * Law No. 73 (June 11, 2003) - Law concerning the implementation by the Ministry of Agriculture, Forestry and Fisheries in a connection with the of Food Sanitation Law * Law No. 97 (June 19, 2003) - Law on preservation of the diversity of the animals by regulation of the use of a transgenic animals * Cabinet Order No. 66 (June 27, 2003) - Cabinet Order related to the Article 1, Paragraph 1 of the Cabinet Order on the Food Safety Council * Cabinet Order No. 67 (June 27, 2003) - Administrative regulations of the Secretariat of the Food Safety Council * Cabinet Ordinance No. 263 (June 19, 2003) - Cabinet Ordinance on the implementation of the Law on preservation of the diversity of the animals by regulation of the use of a transgenic animals 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 REGULATORY DOCUMENTS FROM THE CABINET (CONT.) * Cabinet Ordinance No. 268 (June 20, 2003) - Cabinet Ordinance on enforcement date of the Law concerning the implementation by the Ministry of Agriculture, Forestry and Fisheries in a connection with the of Food Sanitation Law (Enforcement date July 1, 2003) * Cabinet Ordinance No. 272 (June 20, 2003) - Cabinet Ordinance on enforcement date of the Food Safety Basic Law (Enforcement date July 1, 2003) [related law 20030624] * Cabinet Ordinance No. 273 (June 20, 2003) - Cabinet Ordinance on the Food Safety Council * Cabinet Ordinance No. 275 (June 26, 2003) - Cabinet Ordinance revising a part of the Law for the Organization of the Ministry of Health, Labor and Welfare 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. 106 (June 12, 2003) - Ministerial Ordinance partially revising the Ministerial Ordinance about the standards of implementation of the clinical trial of medicinal products * MHLW / Ministry of Economy, Trade and Industry / Ministry of the Environment Notification No. 2 (June 4, 2003) - Ministerial Ordinance partially revising the Ministerial Ordinance concerning the notification on manufacture or import of new chemical entities * MHLW Notification / PFSB Notification No. 0616020 (June 19, 2003) - About release of the report instructions to the Japanese Red Cross Society * MHLW Notification No. 216 (June 2, 2003) - Document partially revising the calculation method of the amount of the expenses which medical treatment requires by the regulation of the Health Insurance Law 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 Notification No. 217 (June 2, 2003) - Document partially revising the standard concerning calculation of amount of the expenses which medical treatment requires by the regulations of Elderly Health Law * MHLW Notification No. 218 (June 2, 2003) - Document partially revising the institutional standards for the basic medical treatment fees [revised Notification 20020180] * MHLW Notification No. 228 (June 6, 2003) - Document partially revising the medical fees of used medicinal products (price standards for medicines prescribed under the Health Insurance System) * MHLW Notification No. 229 (June 12, 2003) - Document on the designation of an orphan drug under the provisions of the Article 77, Paragraph 2, Item 1 of the Pharmaceutical Affairs Law * MHLW Notification No. 230 (June 13, 2003) - Document partially revising the medical fees of used medicinal products (price standards for medicines prescribed under the Health Insurance System) * MHLW Miscellaneous Communication (June 27, 2003) - Proceedings of the First round table on the promotion of the pharmaceutical industry * MHLW / Ministry of Economy, Trade and Industry / Ministry of the Environment Notification No. 2 (June 4, 2003) - Document that provides notification concerning the proposal for an electronic information processing organization pursuant to the provisions of the Article 2, Paragraph 1, Item 2 of the Enforcement Ordinance of the Law Concerning Examination and Regulation of Manufacture, etc. of Chemical Substances Director-General of the Pharmaceutical and Food Safety Bureau * PFSB Notification No. 0515002 (June 3, 2003) - About the special reason to use X-ray devices in the radiation examination room where an X-ray examination room is not provided and the appropriate protective measures * PFSB Notification No. 0515008 (June 4, 2003) - About the medicinal products man of merit - Minister of Health, Labor and Welfare commendation * PFSB Notification No. 0527005 (June 4, 2003) - About the recommendation for the disaster prevention man of merit - prime minister commendation candidate in 2003 (request) * PFSB Notification No. 0529005 (June 5, 2003) - Conclusions in relation to the notice of the Director-General of the PFSB regarding the PMSB/ELD Notification No. 1314 (dated December 26, 2000) to the businesses which have not yet responded * PFSB Notification No. 0604001 (June 6, 2003) - Partial amendment of the 1998 standards for pharmaceutical additives * PFSB Notification No. 0530001 (June 11, 2003) - About the enforcement of the Law (the Law 55 of 2003) partially revising the Food Sanitation Law and the Law partially revising the Health Promotion Law (the Law 56 of 2003) * PFSB Notification No. 0609002 and No. 0609003 (June 16, 2003) - About strengthening the examination in an interview when collecting blood concerning a stay in Europe * PFSB Notification No. 0609004 and No. 0609005 (June 16, 2003) - About the decision regarding the promotion of "Promotion of the blood donation in 2003 fiscal year"", and a request to the all prefectures for creation of a blood donation support plan in the 2003 fiscal year * PFSB Notification No. 0612001 (June 16, 2003) - About the Ministerial Ordinance partially revising the Ministerial Ordinance about the standards of implementation of the clinical trial of medicinal products * PFSB Notification No. 0618009 (June 20, 2003) - About the handling of the records on specific products of human or animal origin in case of abolition of medical institutions * PFSB Notification No. 0624002 (June 24, 2003) - About prescription medicinal products reevaluation results for 2003 (part 1) [quality reevaluation results] * PFSB Notification No. 0624005 (June 24, 2003) - About partial revision of the Standards Part 3 for the medicinal products outside the Japanese Pharmacopoeia [Out of JP Standards Part 3] * PFSB Notification No. 0627002 (June 30, 2003) - About medicinal products reexamination results for 2003 (part 1) * PFSB Miscellaneous Communication (June 27, 2003) - Pharmaceuticals and Medical Devices Safety Information Bulletin No.190 [important information for infliximab （genetical recombination） 3 items] * PFSB Miscellaneous Communication (June 27, 2003) - Proceedings of the first meeting about the state of examination of the herbal medicine tablets (a Western herb is included) as an over-the-counter drug Heads of the Pharmaceutical and Food Safety Bureau Divisions * PFSB, Evaluation and Licensing Division Notification No. 0516001 (June 2, 2003) - About public dissolution test affecting the quality reevaluation of prescription medicinal products (draft) [quality reevaluation specifications] * PFSB, Evaluation and Licensing Division Notification No. 0529008 (June 2, 2003) - About the designation of an orphan drug * PFSB, Evaluation and Licensing Division Notification No. 0602001 (June 3, 2003) - Scope of prescription medicinal products, which are required for submitting preliminary test results related to re-evaluation of quality (26th Round) (quality re-evaluation of generics) * PFSB, Evaluation and Licensing Division Notification No. 0604001 (June 4, 2003) - About the Electronic Common Technical Document specification * PFSB, Evaluation and Licensing Division Notice (June 4, 2003) - Q & A related to the "Electronic Common Technical Document Specification" * PFSB, Evaluation and Licensing Division Miscellaneous Communication (June 4, 2003) - On the soliciting opinions and information in relation to the "Use of electromagnetic tags and electronic signatures in the process of application for manufacture or import approval of new drugs (draft) * PFSB, Evaluation and Licensing Division Notification No. 0603001 (June 5, 2003) - About a revision of the stability examination guideline [ICHQ1AR] * PFSB, Evaluation and Licensing Division Notification No. 0603004 (June 5, 2003) - About the guideline on evaluation of stability data [ICHQ1AR] * PFSB, Evaluation and Licensing Division Notification No. 0603007 (June 5, 2003) - About the guideline about stability examination grade for approval application in climatic region level III and IV [ICHQ1F] * PFSB, Evaluation and Licensing Division Office Working Information (June 5, 2003) - About the application of the bracketing method and matrixing method in the stability tests of raw products and medicinal products * PFSB, Evaluation and Licensing Division Notification No. 0604004 (June 6, 2003) - About the handling of the manufacturing /import application for approval of medicinal products according to the partial amendment of the 1998 pharmaceutical additive standard * PFSB, Evaluation and Licensing Division Notification No. 0604007 (June 6, 2003) - About the addition of a code to the application using flexible disks * PFSB, Evaluation and Licensing Division Notice (June 6, 2003) - On the proper preparation of the Electronic Common Technical Document (draft) * PFSB, Evaluation and Licensing Division Notification No. 0605001 (June 9, 2003) - Assurance of quality and safety in the application for approval of pharmaceutical products and medical devices produced from raw materials from bovine origin from Canada * PFSB, Evaluation and Licensing Division Miscellaneous Communication (June 12, 2003) - Proceedings of the first meeting about the state of examination of the herbal medicine tablets (a Western herb is included) as an over-the-counter drug * PFSB, Evaluation and Licensing Division Notification No. 0612001 (June 16, 2003) - On the handling of report for plans of clinical trials to carried out independently * PFSB, Evaluation and Licensing Division Notification No. 0612004 (June 16, 2003) - Partial revision of the "Handling of the reports for the clinical trials of medicinal products" * PFSB, Evaluation and Licensing Division / PFSB, Safety Division / PFSB, Blood and Blood Products Division - Office Working Information (June 16, 2003) About the public announcement on the revisions of the Pharmaceutical Affairs Law and the blood collection regulations in regard to the "Availability of more efficient and safer use of the pharmaceuticals and medical devices in the medical treatment" * PFSB, Evaluation and Licensing Division - Office Working Information (June 17, 2003) - About the correction public dissolution test affecting the quality reevaluation of prescription medicinal products (draft) [quality reevaluation specifications] * PFSB, Evaluation and Licensing Division Notification No. 0617002 (June 19, 2003) - About a designation of an orphan drug * PFSB, Evaluation and Licensing Division Notification No. 0624001 (June 24, 2003) - Revision of the Guideline on the Impurities in the Medicinal Products with New Active Ingredients * PFSB, Evaluation and Licensing Division - Office Working Information (June 26, 2003) - Correction of the Electronic Common Technical Document specification * PFSB, Evaluation and Licensing Division - Office Working Information (June 26, 2003) - Correction of guideline on evaluation of stability data * PFSB, Evaluation and Licensing Division - Office Working Information (June 30, 2003) - Q & A on how to produce data submitted with application forms for the approval of manufacturing or import of new drugs * 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 (June 2, 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 (June 27, 2003) - About the testing methods and examination standards concerning the examination of the relevant characteristics of specified chemical substances * PFSB, Safety Division Notification No. 053002 (June 2, 2003) - Revisions of the cautions for use of medicinal products [16 OTC cold-medicine products] * PFSB, Safety Division Miscellaneous Communication (June 2, 2003) - About revision of the cautions on use concerning the interstitial pneumonia related to the OTC cold medicines * PFSB, Safety Division Notification No. 0604001 (June 12, 2003) - Revisions of the cautions for use of medicinal products [amantadine hydrochloride, 6 items] * PFSB, Safety Division Notification No. 0604001 (June 12, 2003) - Revisions of the cautions for use of medicinal products [ipratropium bromide, 11 items] * PFSB, Safety Division Office Working Communication (June 16, 2003) - About holding the briefing concerning the revision of the change approval of one approval matter of the application and directions related to glutaraldehyde * PFSB, Safety Division Miscellaneous Communication No. 053002 (June 19, 2003) - Revisions of the cautions for use of medicinal products * PFSB, Safety Division Notification No. 0618001 and No. 0618002 (June 20, 2003) - Survey content and the written method concerning the infectious diseases periodic report for product products of human or animal origin * PFSB, Safety Division Notification No. 0620002, and PFSB, Compliance and Narcotics Division Notification No. 0620004 (June 20, 2003) - About the thoroughness of the quality control of thicket type cardiac pacemaker etc., and the safety control after marketing, etc. * PFSB, Compliance and Narcotics Division Notification No. 0614083 (June 20, 2003) - About the instruction for recall of medical devices by the Japan Medtronic Co. (valve of pig origin) * PFSB, Blood and Blood Products Division Notification No. 0612001 (June 16, 2003) - About the thoroughness of the check of the blood donor's blood donation history * PFSB, Blood and Blood Products Division Notification No. 0609001 (June 16, 2003) - About the target amount of blood which should be secured by blood donation in the 2003 fiscal year * PFSB, Blood and Blood Products Division Office Working Information (June 20, 2003) - About the doubt concerning the improvement of the safety of human-blood-based manufactured blood and human-blood-based manufactured blood substitute medicinal products as established in the Eighth Basic Policy Plan for securing stable supply * PFSB, General Affairs Division / PFSB, Evaluation and Licensing Division / PFSB, Safety Division / PFSB, Compliance and Narcotics Division - Miscellaneous Communication (May 18, 2003) Dispatch of opinions on the "Enforcement of the revision of the Pharmaceutical Affairs Law (proposal)" * PFSB, General Affairs Division / PFSB, Evaluation and Licensing Division / PFSB, Safety Division / PFSB, Compliance and Narcotics Division - Miscellaneous Communication (May 18, 2003) Soliciting opinions on the "Enforcement of the revision of the Pharmaceutical Affairs Law (proposal)" [to be enforced in 2005] * PFSB, Food Safety Department, Standards Division - Miscellaneous Communication (June 30, 2003) About the collection of opinions on the proposal for a guideline about the examination for safety evaluation of the residues of veterinary drugs Other Bureaus of the MHLW / Other related organizations * Health Policy Bureau Notification No. 0430002 (June 26, 2003) About the fundamental plan aimed at the comprehensive promotion of the improvement of the health of the national * Health Policy Bureau Notification No. 0430001 / PFSB, Food Safety Department Notification No. 0430001 (June 26, 2003) Enforcement of health improvement regimes * Health Policy Bureau Notification No. 0624001 (June 27, 2003) About the enforcement of the survey on the actual conditions of the pharmaceuticals/medical devices industry (manufacturing/wholesale business) (at closing the accounts in 2002 fiscal year) * Health Policy Bureau / Economics Affairs Division Notification No. 0606001 and 0606002 (June 6, 2003) About "Price standards for medicines prescribed under the Health Insurance System publication medicinal products code" of medicinal products published afresh by price standards for medicines prescribed under the Health Insurance System * Health Policy Bureau / Economics Affairs Division Notification No. 0605001 (June 9, 2003) About submitting the import plan in the latter six months of the terms of the medicines that should receive "Import quota" of fiscal year 2003 * Health Policy Bureau / Economics Affairs Division Notification No. 0613001 and 0613002 (June 16, 2003) About "Price standards for medicines prescribed under the Health Insurance System publication medicinal products code" of medicinal products published afresh by price standards for medicines prescribed under the Health Insurance System * Health Policy Bureau / Economics Affairs Division Miscellaneous Communication (June 5, 2003) About the situation and the progress of the pharmaceutical industrial vision "Action plan for global competitiveness" * Health Policy Bureau / Economics Affairs Division Office Working Information (June 9, 2003) Survey of the medicinal products manufacturing (import) expenditures classified by all prefectures (as of November 2002) * Health Policy Bureau / Economics Affairs Division Office Working Information (June 17, 2003) About the situation of the medicinal products industry regarding the investment in plants and equipment (a request) * Health Services Bureau, Tuberculosis and Infectious Diseases Control Division Notification No. 0530001 (June 3, 2003) About the response by the quarantine stations to the Severe Acute Respiratory Syndrome (SARS) * Health Services Bureau, Tuberculosis and Infectious Diseases Control Division Notification No. 0605001 (June 9, 2003) About the request for investigation on the circulation of "hakubusin" in animal handling business * Health Services Bureau, Tuberculosis and Infectious Diseases Control Division Notification No. 0605001 (June 9, 2003) About the response by the quarantine stations to the Severe Acute Respiratory Syndrome (SARS) * Health Services Bureau, Tuberculosis and Infectious Diseases Control Division Notification No. 0605002 (June 9, 2003) About the reporting style for "doubtful case" and for "possible case" of SARS (20th news release on the measures against SARS) * Health Services Bureau, Tuberculosis and Infectious Diseases Control Division Office Working Information (June 9, 2003) Information related to "hakubusin" * Health Services Bureau, Tuberculosis and Infectious Diseases Control Division Office Working Information (June 12, 2003) About the administration test point of a SARS corona virus (13th news release on the measures against SARS) * Health Services Bureau, Tuberculosis and Infectious Diseases Control Division Notification No. 0616002 (June 18, 2003) About the travel information regarding Severe Acute Respiratory Syndrome (SARS) (21st news release on the measures against SARS) * Health Services Bureau, Tuberculosis and Infectious Diseases Control Division Notification No. 0626001 (June 24, 2003) About the response by the quarantine stations to the Severe Acute Respiratory Syndrome (SARS) * Health Insurance Bureau, Medical Economics Division Notification No. 0606001 (June 17, 2003) About the notification regarding the partial revision of the prices of the medicinal products in use (Price standards for medicines prescribed under the Health Insurance System) * Health Insurance Bureau, Medical Economics Division Notification No. 0613001 (June 17, 2003) About the notification regarding the partial revision of the prices of the medicinal products in use (Price standards for medicines prescribed under the Health Insurance System) * Equal Employment, Children and Families Bureau Notification No. 052700 (June 4, 2003) Request for cooperation for the execution of the 18th man and women equal opportunity employment month * Labor Standards Bureau Notification No. 0401012 (June 16, 2003) About the development of a guideline on the handrail precedence method of construction III. REGULATORY DOCUMENTS FROM OTHER AUTHORITIES Issuer - Date - Title * Special Committee on Drug Prices of the Central Social Insurance Medical Council - Miscellaneous Communication (June 13, 2003) - Proceedings of the 13th 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 (June 13, 2003) - Annual changes in the medical expenses * Special Committee on Drug Prices of the Central Social Insurance Medical Council - Miscellaneous Communication (June 13, 2003) - Reference data * Special Committee on Drug Prices of the Central Social Insurance Medical Council - Miscellaneous Communication (June 13, 2003) - Reference data (price of medicine calculation rules) 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 (June 13, 2003) - The Central Social Insurance Medical Council Special Committee on Drug Prices special committee reference data * Special Committee on Drug Prices of the Central Social Insurance Medical Council - Miscellaneous Communication (June 13, 2003) - Opinion about the price-of-medicine calculation rules of the new medicinal products * Special Committee on Drug Prices of the Central Social Insurance Medical Council - Miscellaneous Communication (June 13, 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 (June 13, 2003) - On the enforcement schedule of the Prices of Medicines (Drug Tariff List Survey) Fiscal 2003 Year Survey (proposal) * Special Subcommittee on the Basic Problems of the Medical Treatment Fees of the Central Social Insurance Medical Council - Miscellaneous Communication (June 9, 2003) - A About the degree of satisfaction of the patient concerning information services * Special Subcommittee on the Basic Problems of the Medical Treatment Fees of the Central Social Insurance Medical Council - Miscellaneous Communication (June 9, 2003) - Proceeding of the 28th Meeting of the Central Social Insurance Medical Council Special Subcommittee on the Basic Problems of the Medical Treatment Fees * Special Subcommittee on the Basic Problems of the Medical Treatment Fees of the Central Social Insurance Medical Council - Miscellaneous Communication (June 9, 2003) - Image of evaluation of basis fee of hospitalization etc. according to hospitalization period * Special Subcommittee on the Basic Problems of the Medical Treatment Fees of the Central Social Insurance Medical Council - Miscellaneous Communication (June 9, 2003) - About the nursing recuperation type medical facilities * Special Subcommittee on the Basic Problems of the Medical Treatment Fees of the Central Social Insurance Medical Council - Miscellaneous Communication (June 9, 2003) - The directions of the future measure towards reform of mental health welfare * Special Subcommittee on the Basic Problems of the Medical Treatment Fees of the Central Social Insurance Medical Council - Miscellaneous Communication (June 9, 2003) - Written report situation etc. of the main facilities standards * Special Subcommittee on the Basic Problems of the Medical Treatment Fees of the Central Social Insurance Medical Council - Miscellaneous Communication (June 9, 2003) - Outline of trend of recent medical treatment expense * Special Subcommittee on the Basic Problems of the Medical Treatment Fees of the Central Social Insurance Medical Council - Miscellaneous Communication (June 9, 2003) - The main things of the present medical treatment fee points used for evaluation of the information services * Special Subcommittee on the Basic Problems of the Medical Treatment Fees of the Central Social Insurance Medical Council - Miscellaneous Communication (June 9, 2003) - About the insurance application of the regenerative medicine (advanced medical technology) * Special Subcommittee on the Basic Problems of the Medical Treatment Fees of the Central Social Insurance Medical Council - Miscellaneous Communication (May 26, 2003) - About holding investigation briefings for the diagnosis group classification review * Special Subcommittee on the Basic Problems of the Medical Treatment Fees of the Central Social Insurance Medical Council - Miscellaneous Communication (June 25, 2003) - Proceeding of the 29th Meeting of the Central Social Insurance Medical Council Special Subcommittee on the Basic Problems of the Medical Treatment Fees * Special Subcommittee on the Basic Problems of the Medical Treatment Fees of the Central Social Insurance Medical Council - Miscellaneous Communication (June 25, 2003) - "Examination team on the reforms of the medical care supply system" - Summary of the Vision plan of reform of the medical care supply system (extraction) (Ministry of Health, Labor and Welfare on April 30, 2003) * Special Subcommittee on the Basic Problems of the Medical Treatment Fees of the Central Social Insurance Medical Council - Miscellaneous Communication (June 25, 2003) - Evaluation on medical treatment fee(beds for general patients) * Special Subcommittee on the Basic Problems of the Medical Treatment Fees of the Central Social Insurance Medical Council - Miscellaneous Communication (June 25, 2003) - Proceeding of the Meeting of the Central Social Insurance Medical Council Special Subcommittee on the Basic Problems of the Medical Treatment Fees (draft) (held on March 19) * Special Subcommittee on the Basic Problems of the Medical Treatment Fees of the Central Social Insurance Medical Council - Miscellaneous Communication (June 25, 2003) - Proceeding of the Meeting of the Central Social Insurance Medical Council Special Subcommittee on the Basic Problems of the Medical Treatment Fees (draft) (held on March 26) * Special Subcommittee on the Basic Problems of the Medical Treatment Fees of the Central Social Insurance Medical Council - Miscellaneous Communication (June 25, 2003) - Evaluation on medical treatment fee(mental disease bed and home support) * Special Subcommittee on the Basic Problems of the Medical Treatment Fees of the Central Social Insurance Medical Council - Miscellaneous Communication (June 25, 2003) - Outline of the "Directions of the future measure towards reform of mental health welfare" (mental health welfare task force interim report) * Special Subcommittee on the Basic Problems of the Medical Treatment Fees of the Central Social Insurance Medical Council - Miscellaneous Communication (June 25, 2003) - The present condition and directivity of mother-and-child medical treatment * Special Subcommittee on the Basic Problems of the Medical Treatment Fees of the Central Social Insurance Medical Council - Miscellaneous Communication (June 27, 2003) - The investigation item outline about the impact evaluation of DPC (proposal) * 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 30th Meeting of the Central Social Insurance Medical Council Special Subcommittee on the Basic Problems of the Medical Treatment Fees * Special Sectional Committee on the Insurance of the Medical Care Materials of the Central Social Insurance Medical Council - Miscellaneous Communication (June 13, 2003) - Reference price adjustment and re-calculation, etc. * Special Sectional Committee on the Insurance of the Medical Care Materials of the Central Social Insurance Medical Council - Miscellaneous Communication (June 13, 2003) - Opinion concerning standard of insurance repayment price calculation of specific insurance medical treatment material * Special Sectional Committee on the Insurance of the Medical Care Materials of the Central Social Insurance Medical Council - Miscellaneous Communication (June 13, 2003) - Proceeding of the 11th Meeting of the Special Sectional Committee on the Insurance of the Medical Care Materials * Special Sectional Committee on the Insurance of the Medical Care Materials of the Central Social Insurance Medical Council - Miscellaneous Communication (June 13, 2003) - On the enforcement schedule of the Prices of Medicines (Drug Tariff List Survey) Fiscal 2003 Year Survey (proposal) * Special Sectional Committee on the Insurance of the Medical Care Materials of the Central Social Insurance Medical Council - Miscellaneous Communication (June 13, 2003) - Reference data * Central Social Insurance Medical Council - Miscellaneous Communication (June 27, 2003) - About the clinical trials of doctor initiation * Central Social Insurance Medical Council - Miscellaneous Communication (June 27, 2003) - On the enforcement schedule of the Prices of Medicines (Drug Tariff List Survey) Fiscal 2003 Year Survey (proposal) * Central Social Insurance Medical Council - Miscellaneous Communication (June 27, 2003) - Approval of advanced medical technology * Central Social Insurance Medical Council - Miscellaneous Communication (June 27, 2003) - Proceeding of the 34th General Meeting of the Central Social Insurance Medical Council * Central Social Insurance Medical Council - Miscellaneous Communication (June 27, 2003) - About the insurance application of the clinical examination * Central Social Insurance Medical Council - Miscellaneous Communication (June 27, 2003) - New insurance application * Central Social Insurance Medical Council - Miscellaneous Communication (June 27, 2003) - Special Organization Committee on Insurance of Medical Care Materials (proposal) * Central Social Insurance Medical Council - Miscellaneous Communication (June 27, 2003) - About the execution schedule in 2003 fiscal year of the investigation of the prices of the specific insurance medical treatment materials (proposal) * Central Social Insurance Medical Council - Miscellaneous Communication (June 27, 2003) - Special Organization Committee on the Investigation of Medical Treatment Fees (proposal) * Ministry of Economy, Trade and Industry Notification No. 207 (June 6, 2003) - Document (related to SARS) on the partial revision of the rules for announcements of the places of origin of the freight which should receive items of the freight which should receive import allotment, permission about import and other necessary matters * Minister of Agriculture, Forestry and Fisheries Ordinance No. 54 (June 10, 2003) - Ministerial Ordinance which revises a part of ministerial ordinance about the regulations for use of drugs for animals * Minister of Agriculture, Forestry and Fisheries Ordinance No. 56 (June 23, 2003) - Ministerial Ordinance which revises some regulatory rules, such as on drugs for animals * Organization for Pharmaceutical Safety and Research Notification No. 632 (June 30, 2003) - About the establishment of Clinical Trials Consultation Division and other changes * National Federation of Health Insurance Societies - Miscellaneous Communication (June 9, 2003) - Investigation study report about the new payment system for patients on subacute to long term care (abstract version) IV. DOCUMENTS FROM INDUSTRY GROUPS Issuer - Date - Title * FPMAJ Rapid Communication No. 340 (June 5, 2003) - On the "Opinion on information reporting of the post-marketing safety measures related to the medicinal products of human or animal origin" * FPMAJ Rapid Communication No. 372 (June 12, 2003) - Revision of Cautions for use of the OTC cold medicines * FPMAJ Rapid Communication No. 388 (June 19, 2003) Q&A documents of the FPMAJ regarding the Notice "Raw materials from bovine or human origin used for production of prescription medicines and medical devices, and assurance of the quality and safety" * FPMAJ Rapid Communication No. 400 (June 25, 2003) - On the procedure for the clinical trials carried out by medical doctors themselves * FPMAJ Rapid Communication No. 406 (June 26, 2003) - Regarding the distribution of the FPMAJ document "Q&A on the products of human or animal origin" Communications FPMAJ Federation of Pharmaceutical Manufacturers' Associations of Japan JPMA Japan Pharmaceutical Manufacturers Association OPMA Osaka Pharmaceutical Manufacturers Association JMA Japan Medical Association JPA Japan Pharmaceutical Association The highest level administrative documents issued only by various industry associations and trade groups, and professional organization DOCUMENTS FROM INDUSTRY GROUPS (CONT.) * FPMAJ Rapid Communication No. 409 (June 26, 2003) - Regarding the distribution of the FPMAJ document "Q&A on the infectious diseases periodic report" * Society of Japanese Pharmacopoeia / Federation of Pharmaceutical Manufacturers' Associations of Japan - Miscellaneous Communication (June 30, 2003) - Drug Safety Update (DSU No. 120) - Guidance on the changes in cautions for prescription medicinal products * JPMA Miscellaneous Communication (June 11, 2003) - About the points of concern related to the product information outline examination example (report No.52) * JMA Miscellaneous Communication (June 9, 2003) - Proposal of "New payment system for the long-term medical-treatment patients" * OPMA Notice No. 180 (June 13, 2003) - About the detailed rules for the registration of the Drug Master Plan * OPMA Notice No. 180 (June 13, 2003) - - About the detailed rules for the registration of the Drug Master Plan * JPA Office Working Information No. 60 (June 30, 2003) - About the 2003 Annual training meeting of the Industrial Pharmacists' Section of the Japan Pharmaceutical Association V. MISCELLANEOUS Issuer - Date - Title * National Printing Bureau (Independent Administrative Agency) - Miscellaneous Communication (June 4, 2003) - Public announcement of the successful bidders of medicinal products * National Printing Bureau (Independent Administrative Agency) - Miscellaneous Communication (June 4, 2003, 2003) - Public announcement of the successful bidders of medicinal products * National Printing Bureau (Independent Administrative Agency) - Miscellaneous Communication (June 12, 2003, 2003) - Public announcement of the successful bidders of medicinal products * National Printing Bureau (Independent Administrative Agency) - Miscellaneous Communication (June 12, 2003, 2003) - Public announcement of the successful bidders of medicinal products * National Printing Bureau (Independent Administrative Agency) - Miscellaneous Communication (June 18, 2003) - MHLW Ordinance No. 95 dated May 20 - Corrigenda [Ministerial Ordinance 20030541 Correction] Communications Organizations National Printing Bureau Drug Products Liability Center The administrative documents issued by various organizations MISCELLANEOUS (CONT.) * National Printing Bureau (Independent Administrative Agency) - Miscellaneous Communication (June 30, 2003) - Public announcement of the successful bidders of medicinal products * Drug Products Liability Center - Miscellaneous Communication (June 11, 2003) - Drug Products Liability Center FAX communication No. 86 * Okochi Memorial Society (Foundation) - Miscellaneous Communication (June 4, 2003) Recommendation for the 50th (2003 fiscal year) Okochi prize award candidate 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. Translation of the titles in English is provided here solely by the Jouhou Koukai Services. While utmost care has been taken both linguistically and organizationally to reflect into the English translation the language, abbreviations, professional jargon, style and conventions used in the original texts, no claims either expressed or implied are made for completeness and correctness. Some of the conventions used originate from legacy documents earlier translated to English under the supervision of the MHLW. The Japanese Government does not provide authorized (officially sanctioned) translations of its documents. The translations here are tentative. In a case of legal dispute, the original texts in Japanese will prevail. The translation, formatting, indexing and hyperlinking of the text are copyrights of the Jouhou Koukai Services LLC Worldwide Copyright (c) 2001-2003 by JKS LLC Reproduction in whole or part without permission is forbidden. www.jouhoukoukai.com Note: See in the JKS Document Store the JKS document 4_D_K001. Note of the translator: By the investigator himself/herself. Note: See in the JKS Document Store the JKS document 7_D_K002. Note of the translator: Paguma larvata、masked palm civet Note of the translator: Paguma larvata、masked palm civet. Note of the translator: Section for the pharmacists working in the pharma industry. Note of the translator: Foundation in memory of Dr. Masatoshi Okochi, scientist, inventor and founder of the RIKEN Institute. Japanese Pharmaceutical Affairs Authorities Regulatory Documents June 2003 Copyright (c) 2001-2003 by JKS LLC - 2 - Japanese Pharmaceutical Affairs Authorities Regulatory Documents June 2003 Copyright (c) 2001-2003 by JKS LLC - - 25 -