Japanese Pharmaceutical Affairs Authorities Regulatory Documents - August 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 * Cabinet Ordinance (August 1, 2003) - MHLW Ordinance No. 348 on the Law which revises a part of Law which revises a part of Health Promotion Law * Cabinet Ordinance (August 1, 2003) - MHLW Ordinance No. 349 on the Law which revises a part of Food Sanitation Law * Cabinet Office in Charge of Disaster Prevention - Miscellaneous Communication (August 29, 2003) - About holding of an international disaster prevention open forum (a guidance) 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 Notification No. 293 (August 14, 2003) - Document on the designation of an orphan drug under the provisions of the Article 77-2, Paragraph 1 of the Pharmaceutical Affairs Law * MHLW Notification No. 293 (August 14, 2003) - Documents partially revising the designated standards for distribution and sales of goods * MHLW Miscellaneous Communication (August 28, 2003) - MHLW official announcement of appointment (August 28) * MHLW Miscellaneous Communication (August 29, 2003) - MHLW official announcement of appointment (August 29) * MHLW Miscellaneous Communication (August 29, 2003) - MHLW official announcement of appointment (August 29) * MHLW Miscellaneous Communication (August 29, 2003) - MHLW official announcement of appointment (August 29) 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 Miscellaneous Communication (August 29, 2003) - MHLW official announcement of appointment (August 29) * MHLW Miscellaneous Communication (August 29, 2003) - MHLW official announcement of appointment (August 29) * MHLW / Ministry of Economy, Trade and Industry - Miscellaneous Communication (August 28, 2003) - Establishment of Japanese Industrial Standards Director-General of the Pharmaceutical and Food Safety Bureau * PFSB Notification No. 0812003 (August 12, 2003) - About the recommendations for the spring of 2004 bestowal of orders, awards and recommendation for prize candidates to receive the medal of honor (request) * PFSB Notification No. 0827003 (August 27, 2003) - About the Manufacture and Import Approval application for non-prescription medicinal products * PFSB Notification No. 0828003 (August 28, 2003) - Document partially revising the designated standards for distribution and sales of goods * PFSB Notification No. 0828010 (August 28, 2003) - About the change of the style and the method for reporting of adverse events of the medicinal products * PFSB Notification No. 0829006 (August 29, 2003) - On the working principles (guidelines) for the disposal of sales prohibition of foods or foodstuffs on the base of the provisions of Article 4-2 of the Food Sanitation Law * PFSB Notification No. 0829007 (August 29, 2003) - Guiding principles for the surveillance, instruction for rationalization, such as a ban on the advertising of misleadingly exaggerated claims about the health maintaining enhancement effect provided by the stuffs sold as food * PFSB Miscellaneous Communication (August 25, 2003) - About the dispatch of posters about reporting of side effects from the medical institutions * PFSB Miscellaneous Communication (August 28, 2003) - Outline of the draft budget estimation for the 2004 budget (Pharmaceutical and Food Safety Bureau) * PFSB Miscellaneous Communication (August 28, 2003) - Personnel changes (as of August 28, 2003) (Pharmaceutical and Food Safety Bureau) * PFSB Miscellaneous Communication (August 29, 2003) - Personnel changes (as of August 29, 2003) (Pharmaceutical and Food Safety Bureau) * PFSB Miscellaneous Communication (August 29, 2003) - Office layout plan (as of August 29, 2003) (Pharmaceutical and Food Safety Bureau) Heads of the Pharmaceutical and Food Safety Bureau Divisions * PFSB, Evaluation and Licensing Division Notification No. 0801001 / PFSB, Safety Division Notification No. 0801001 (August 1, 2003) - About the handling of the risk assessment in the cases of complete change of the application for medicines and medical devices where materials originating from living organisms are used * PFSB, Evaluation and Licensing Division Notification No. 0801002 (August 1, 2003) - About the designation of an orphan drug * PFSB, Evaluation and Licensing Division Notification No. 0805001 (August 5, 2003) - Scope of prescription medicinal products, which are required for submitting preliminary test results related to re-evaluation of quality (27th Round) (prescription medicinal products) * PFSB, Evaluation and Licensing Division Notification No. 0805004 (August 5, 2003) - About the changes in the public dissolution test affecting the quality reevaluation of the active ingredients of the prescription medicinal products (proposal) * PFSB, Evaluation and Licensing Division Notification No. 0805007 (August 5, 2003) - About the handling of the reports for adverse events in investigator-initiated clinical trials * PFSB, Evaluation and Licensing Division Notification No. 0807001 (August 7, 2003) - About the partial revision of the general names of medicinal products (notice) * PFSB, Evaluation and Licensing Division Notification No. 0808003 (August 8, 2003) - About the handling of medicinal products containing pseudoephedrine chloride and pseudoephedrine sulphate * PFSB, Evaluation and Licensing Division Notification No. 0827002 (August 27, 2003) - About the points to pay attention regarding the Manufacturing and Import Approval application for non-prescription medicinal products * PFSB, Evaluation and Licensing Division Notification No. 0828005 / PFSB, Evaluation and Licensing Division Notification No. 0828006 (August 28, 2003) - About the grasp of the real use of pharmaceutical additive (a request) * PFSB, Evaluation and Licensing Division Notification No. 0828010 / PFSB, Safety Division Notification No. 0828001 - About independent check of the forceps cork of medical endoscopes * PFSB, Evaluation and Licensing Division - Office Working Information (August 1, 2003) - Q &A on the quality and safety assurance of the medicines and medical devices produced by using products from animal origin from Canadian cattle * PFSB, Evaluation and Licensing Division - Office Working Information (August 1, 2003) - About the survey on prices of medicinal products in use (price standards for medicines prescribed under the Health Insurance System ) * PFSB, Evaluation and Licensing Division - Office Working Information (August 5, 2003) - About the changes in the public dissolution test affecting the quality reevaluation of the active ingredients of the prescription medicinal products (proposal) * PFSB, Evaluation and Licensing Division - Miscellaneous Communication (August 11, 2003) - About the partial revision of the Poisonous and Deleterious Substances Law (deadline for submission of proposals August 25, 2003) * PFSB, Evaluation and Licensing Division - Office Working Information (August 20, 2003) - About the changes in the public dissolution test affecting the quality reevaluation of the active ingredients of the prescription medicinal products (proposal) * PFSB, Evaluation and Licensing Division - Office Working Information (August 20, 2003) - Q & A concerning the managers handling (import / sale) of medicinal products originating from living organisms * PFSB, Evaluation and Licensing Division - Miscellaneous Communication (August 21, 2003) - About the discontinuation of standard products of the National Institute of Health Sciences * PFSB, Evaluation and Licensing Division / PFSB, Safety Division - Office Working Information (August 26, 2003) - About the "Handling of the safety information after approval: definition of the terms for emergency reports and the standard of reports" (proposal) * PFSB, Evaluation and Licensing Division / PFSB, Safety Division - Miscellaneous Communication (August 26, 2003) - About the soliciting of opinions and information concerning the proposal for "Handling of the safety information after approval: definition of the terms for emergency reports and the standard of reports" * PFSB, Evaluation and Licensing Division / PFSB, Safety Division - Office Working Information (August 27, 2003) - Q & A on the approval application classification for non-prescription medicinal products and about the attached documents * 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 (August 1, 2003) - About the proposal procedure for a small quantity of new chemical entity * 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 (August 21, 2003) - About the manufacture and import notification of new chemical entities * PFSB, Safety Division Notification No. 0808001 (August 8, 2003) - About the safety measures concerning the intracerebral bleeding caused by medicinal products containing phenylpropanolamine chloride (term for response September 11, 2003 by the Federation of Pharmaceutical Manufacturers' Associations of Japan) * PFSB, Safety Division Notification No. 0808003 (August 8, 2003) - About the safety measures concerning the intracerebral bleeding caused by medicinal products containing phenylpropanolamine chloride (appendices) * PFSB, Safety Division Notification No. 0812001 (August 12, 2003) - About the revision of cautions for use of medicinal products [interferon gamma-1a (genetic recombination), 8 items] * PFSB, Safety Division Notification No. 0828005 (August 28, 2003) - About the notification for reporting accidents such as defects of medical devices * PFSB, Safety Division - Miscellaneous Communication (August 8, 2003) - About the safety measures concerning the intracerebral bleeding caused by medicinal products containing phenylpropanolamine chloride * PFSB, Safety Division - Office Working Information (August 12, 2003) - About the revision of cautions for use of medicinal products [Toremifene citrate, 10 items] * PFSB, Safety Division - Office Working Information (August 21, 2003) - About Q&A concerning the side effects reports * PFSB, Safety Division - Miscellaneous Communication (August 28, 2003) - Pharmaceuticals and Medical Devices Safety Information Bulletin No. 192 * PFSB, Compliance and Narcotics Division - Office Working Information (August 29, 2003) - About the public comments concerning the implementations of the standards for manufacture management (GMP) and quality control * PFSB, Blood and Blood Products Division Notification No. 0812001 / Notification No. 0812002 (August 12, 2003) - About the handling of the blood substitution medicinal products in relation to the periodic report system for infections * PFSB, Food Safety Department, Standards Division Notification No. 0829001 / Division Notification No. 0829005 (August 29, 2003) Points of concern in relations to the Guiding principles for the surveillance, instruction for rationalization, such as a ban on the advertising of misleadingly exaggerated claims about the health maintaining enhancement effect provided by the stuffs sold as food (pertinent information carried in text) * Health Services Bureau, Tuberculosis and Infectious Diseases Control Division - Miscellaneous Communication (August 21, 2003) About clarification regarding the ""About reexamination of the measures against infections (proposal)" * Health Insurance Bureau, Medical Economics Division - Office Working Information (August 28, 2003) About the findings on domestic/overseas prices of medicines and medical devices in year 2002 * Health Insurance Bureau - Miscellaneous Communication (August 28, 2003) - Personnel changes (as of August 28, 2003) (Health Insurance Bureau) * Health Insurance Bureau - Miscellaneous Communication (August 29, 2003) - Personnel changes (as of August 29, 2003) (Health Insurance Bureau) * Health Insurance Bureau - Miscellaneous Communication (August 29, 2003) - Office layout plan (as of August 29, 2003) (Health Insurance Bureau) * Equal Employment, Children and Families Bureau Notification No. 0808003 (August 8, 2003) - About the revision of the indicators for co-existing index * MHLW, Food Sanitation Council, Investigation Committee on Safe technologies, Blood Products Group - Miscellaneous Communication (August 13, 2003) List of the Reference materials of the Blood Products Group of the Investigation Committee on Safe technologies to the Food Sanitation Council National Hospitals * National Hospitals and Sanatoria United Study Group - Miscellaneous Communication (August 21, 2003) - About the results of the investigation of the generic drug adoption situation in the national hospitals III. REGULATORY DOCUMENTS FROM OTHER AUTHORITIES Issuer - Date - Title * Organization for Pharmaceutical Safety and Research Miscellaneous Communication (August 29, 2003) - Government-affiliated corporation - Relevant for the year 2002 accounting period financial statements Communications The highest level administrative documents issued by various authorities CSIMC Central Social Insurance Medical Council Ministries Ministry of Economy, Trade and Industry IV. DOCUMENTS FROM INDUSTRY GROUPS Issuer - Date - Title * FPMAJ Rapid Communication No. 498 (August 5, 2003) - Handling of the risk assessment in supplemental applications for medicines and medical devices which used raw materials from bovine origin * FPMAJ Rapid Communication No. 524 (August 18, 2003) - About the FPMAJ Q & A regarding the clinical trials with designated medicinal products originating from living organisms and about the handling of the clinical trial notification by SMO * FPMAJ Rapid Communication No. 537 (August 22, 2003) - About the guidance for the training courses for pharmaceutical production managers in the 2003 fiscal year * FPMAJ Rapid Communication No. 540 (August 22, 2003) - About the solicitation of opinions from pharmaceutical production managers in the training courses in the 2003 fiscal year 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.) * FPMAJ Rapid Communication No. 546 (August 25, 2003) - About the contents confirmation of the findings regarding the "Corporate Codes for Tablet and Capsules Forms of Pharmaceuticals" * FPMAJ Rapid Communication No. 553 (August 29, 2003) - About the guidance regarding the presentation (a notice) and the briefing session in relation with the quality reevaluation of 116 antimicrobial ingredients except those against resistant bacterial strains * FPMAJ - Project BSE Miscellaneous Communication (August 7, 2003) - Urgent "Information" (supplemental information to the FPMAJ Rapid Communication * Society of Japanese Pharmacopoeia / Federation of Pharmaceutical Manufacturers' Associations of Japan - Miscellaneous Communication (August 26, 2003) - Drug Safety Update (DSU No. 121) - Guidance on the changes in cautions for prescription medicinal products * Osaka Pharmaceutical Manufacturers Association - Miscellaneous Communication (August 6, 2003) - About an information request on the month of December publication enquiry report items / new kit V. MISCELLANEOUS Issuer - Date - Title * National Printing Bureau (Independent Administrative Agency) - Miscellaneous Communication (August 21, 2003) - Public announcement of the successful bidders of medicinal products * Drug Products Liability Center - Miscellaneous Communication (August 11, 2003) - Drug Products Liability Center FAX Communication No. 88 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. 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: Also known as "Standard Drug Prices" Note: Refers to the juridical status of the OPSR. Note: SMO, Site Management Organization (the English abbreviation is also used in Japan). Note: BSE, Bovine Spongiform Encephalopathy (the English abbreviation used in the Japanese original). Japanese Pharmaceutical Affairs Authorities Regulatory Documents August 2003 Copyright (c) 2001-2003 by JKS LLC - 2 - Japanese Pharmaceutical Affairs Authorities Regulatory Documents August 2003