SUPPLEMENT II TO THE JAPANESE PHARMACOPOEIA …

1 SUPPLEMENT IITOTHE JAPANESEPHARMACOPOEIASEVENTEENTH EDITIONO cial from June 28, 2019 English VersionTHE MINISTRY OF HEALTH, LABOUR AND WELFAREN otice: ThisEnglish Versionof the JAPANESE PHARMACOPOEIA is publishedfor the convenience of users unfamiliar with the JAPANESE language. Whenand if any discrepancy arises betweenthe JAPANESE original and its Englishtranslation, the former is in JapanThe Ministry of Health, Labour andWelfare Ministerial Notification No. 49 Pursuant to Paragraph 1, Article 41 of Act on Securing Quality, Efficacy andSafety of Products Including Pharmaceuticals and Medical Devices (Act No. 145,1960), this notification stated that a part of the JAPANESE PHARMACOPOEIA was revisedas follows*.

2 NEMOTO TakumiThe Minister of Health, Labour and WelfareJune 28, 2019A part of the JAPANESE PHARMACOPOEIA (Ministerial Notification No. 64, 2016) wasrevised as follows*.(The text referred to by the term ``as follows'' are omitted here. All of the revisedJapanese PHARMACOPOEIA in accordance with this notification (hereinafter referred toas ``new PHARMACOPOEIA '' in SUPPLEMENT 2) are made available for public exhibitionat the Pharmaceutical Evaluation Division, Pharmaceutical Safety and Environmen-tal Health Bureau, Ministry of Health, Labour and Welfare, at each Regional Bureauof Health and Welfare, and at each Prefectural Office in Japan).Supplementary Provisions(Effective Date)Article 1 This Notification is applied from June 28, 2019.

3 (Transitional measures)Article 2 In the case of drugs which are listed in the JAPANESE PHARMACOPOEIA (hereinafter referred to as ``previous PHARMACOPOEIA '') [limited to those listed innew PHARMACOPOEIA ] and drugs which have been approved as of June 28, 2019 asprescribed under Paragraph 1, Article 14 of Act on Securing Quality, Efficacy andSafety of Products Including Pharmaceuticals and Medical Devices [includingdrugs the Minister of Health, Labour and Welfare specifies (the Ministry of Healthand Welfare Ministerial Notification No. 104, 1994) as of June 27, 2019 as thoseexempted from marketing approval pursuant to Paragraph 1, Article 14 of thesame law (hereinafter referred to as ``drugs exempted from approval'')], the Stand-ards established in the previous PHARMACOPOEIA (limited to part of the Standardsfor the drugs concerned) may be accepted to conform to the Standards establishedin the new PHARMACOPOEIA before and on December 31, 2020.

4 In the case of drugswhich are listed in the new PHARMACOPOEIA (excluding those listed in the previousPharmacopoeia) and drugs which have been approved as of June 28, 2019 asprescribed under the Paragraph 1, Article 14 of the same law (including those ex-empted from approval), they may be accepted as those being not listed in the newPharmacopoeia before and on December 31, 2020.(Partial revision of Products Delivery Rules of National Institute of Infectious Dis-eases)Article 3 Omitted.*The term ``as follows'' here indicates the content of SUPPLEMENT II to the JAPANESE PharmacopoeiaSeventeenth Edition from General Notice to Ultraviolet-visible Reference Spectra (pp. 2877 2991). iSupplement II to The JAPANESE PHARMACOPOEIA ,Seventeenth 2991 General Notices.

5 2877 General Rules for Preparations .. 2879 General Tests, Processes and Apparatus .. Liquid Chromatography .. Raman Residual Solvents .. Conductivity Elemental Impurities Procedures .. Rheological Measurements for Semi-solid Preparations .. Insoluble Particulate Matter Test forTherapeutic Protein Injections .. Reference Standards .. Standard Solutions for VolumetricAnalysis .. Standard Solutions .. Reagents, Test Solid Supports/Column Packingsfor 2908O cial 2909 Crude Drugs and Related 2973 Infrared Reference 2987 Ultraviolet-visible Reference 2991 General InformationG1 Physics and ChemistryControl of Elemental Impurities inDrug 2993G3 Biotechnological/Biological ProductsHost Cell Protein Assay.

6 2997 Total Protein 3000G4 MicroorganismsMedia Fill Test (Process Simulation) .. 3000 Microbiological Environmental Moni-toring Methods of Processing Areasfor Sterile Pharmaceutical Products .. 3000 Parametric Release of Terminally Steri-lized Pharmaceutical Products .. 3000G5 Crude DrugsPurity Tests on Crude Drugs usingGenetic Information .. 3000On the Scienti c Names of Crude Drugslisted in the JP .. 3005G8 WaterQuality Control of Water for Pharma-ceutical Use .. 3006G10 OthersBasic Concepts for Quality Assuranceof Drug Substances and Drug 3006 Concept on Impurities in Chemicallysynthesized Drug Substances andDrug 3008 Glossary for Quality by Design (QbD),Quality Risk Management (QRM)and Pharmaceutical Quality System(PQS).

7 3010 International Harmonization Imple-mented in the JAPANESE Pharmaco-poeia Seventeenth Edition .. 3019 Index in Latin 3039 Index in 3041iiPREFACEThe 17th Edition of the JAPANESE PHARMACOPOEIA (JP) was promulgated by Ministerial of the Ministry of Health, Labour and Welfare(MHLW) on March 7, july 2016, the Committee on JP established thebasic principles for the preparation of the JP 18th Edi-tion, setting out the roles and characteristics of the JP,the definite measures for the revision, and the date ofthe was agreed that the JP should provide an officialstandard, being required to assure the quality of medi-cines in Japan in response to the progress of scienceand technology and medical demands at the time.

8 Itshould define the standards for specifications, as wellas the methods of testing to assure overall quality ofall drugs in principle, and it should have a role inclarifying the criteria for quality assurance of drugsthat are recognized to be essential for public healthand medical JP has been prepared with the aid of theknowledge and experience of many professionals inthe pharmaceutical field. Therefore, the JP shouldhave the characteristics of an official standard, whichmight be widely used by all parties concerned, and itshould play an appropriate role of providing informa-tion and understanding about the quality of drugs tothe public. Moreover, as a pharmaceutical qualitystandard, it should contribute promoting and main-taining of advancedness as well as international con-sistency and harmonization of technical requirementsin the international the Committee, the five basic principles of JP,which we refer to as the ``five pillars'', were estab-lished as follows: 1) Including all drugs which are im-portant from the viewpoint of health care and medicaltreatment; 2) Making qualitative improvement by in-troducing the latest scienceand technology; 3) Furtherpromoting internationalization in response to globali-zation of drug market.

9 4) Making prompt partial revi-sion as necessary and facilitating smooth administra-tive operation; and 5) Ensuring transparency regard-ing the revision, and disseminating the JP to the pub-lic. It was agreed that the Committee on JP shouldmake efforts, on the basis of these principles, to en-sure that the JP is used more effectively in the fields ofhealth care and medical treatmentbytakingappropri-ate measurements, including getting the understandingand cooperation of other parties was also agreed that JP articles should coverdrugs, which are important from the viewpoint ofhealth care and medical treatment, clinical perform-ance or merits and frequency of use, as soon as possi-ble after they reach the target date for the publication of JP 18th Edi-tion (the JAPANESE edition)

10 Was set as April drafts are discussed in the following committeesthat were established in the Pharmaceuticals and Med-ical Devices Agency: Expert Committee; Sub-expertCommittee; Sub-committee on Manufacturing Proc-ess-related Matters; Committee on Chemicals; Com-mittee on Antibiotics; Committee on Biologicals;Committee on Crude Drugs; Committee on Phar-maceutical Excipients; Committee on Physico-Chemi-cal Methods; Committee on Drug Formulation; Com-mittee on Physical Methods; Committee on BiologicalMethods; Committee on Nomenclature for Phar-maceuticals; Committee on International Harmoniza-tion; and Committee on Reference Standards. Fur-thermore, working groups are established under theExpert Committee, Committee on Pharmaceutical Ex-cipients, Committee on Physico-Chemical Methodsand Committee on Drug committees initiated deliberations on several revisions covering subjects in General No-tices, General Rules for Preparations, General Tests,Monographs, Ultraviolet-visible Reference Spectraand Infrared Reference Spectra for which discussionswere finished between April 2017 and November 2018,were prepared for a SUPPLEMENT to the JP of discussions in the committees to pre-pare the SUPPLEMENT drafts were as follows: ExpertCommittee (11, including a working group).