Chinese Pharmacopoeia Commission
Chinese Pharmacopoeia CommissionStrasbourg, France20,February, 2020Previous versions of ChinesePharmacopoeia, ten versions in all1953 1963 1977 1985 1990 1995 2000 2005 2010 20151
Preparation Outline of ChinesePharmacopoeia 2020- Guiding s on五大发展理念CoordinationInsisting onOpeningStrengtheningSharingPreparation Outline of ChinesePharmacopoeia 2020-Guiding IdeologyStandardprocedurePreciseprocessScientific andrationalPrecisemethodAdvanced ct and selfconscious42
Progress in Pharmacopeia Volume I for TCM Volume II for chemical products Volume III for biological products Volume IV for general chapters,pharmaceutical excipients and drugpackaging materialsVolume I (TCM) 218 medicinal Materia Medica monographs to berevised Added general requirements for heavy metal harmfulsubstances and pesticide residues to more than 500plant-based medicinal materials Revised 7 vegetable oil and extract standards 117 new monographs and 160 revised monographs inTraditional Chinese Patent Medicines3
Volume I (TCM) In safety control, putting forward therequirement for effective control of the impact ofexogenous pollutants and endogenous toxicingredients on TCM safety In effectiveness control, putting forward therequirement for strengthening the specificity andintegrality of standard, and especially carryingout the study of biological assessment anddetermination method based on the clinicalefficacy of TCMII. Volume II (Chemical products) 117 varieties to be increased and 2385 varieties tobe revised Safety control① Further improve the analysis method of impurities andrelevant substances② Promote the application of advanced testing techniques.③ Especially strengthen the control of toxic and harmfulimpurities ( especially genotoxic impurity) .④ Strengthen the study of drug safety control items and limitstandard.4
II. Volume II (Chemical products) Effectiveness controlReflect the achievement of drug quality and efficacycompliance evaluation in the improvement of qualitystandard of relevant preparations, and have furtherimproved the dissolution and releasing rate testingmethod of conventional solid preparations.III. Volume III (Biological Products) 23 newly increased monographs, 126 revisedmonographs 4 newly increased and 4 revised general chapters 2 newly increased monographs and 8 revisedmonographs in the general technical requirements forbiological products 14 new general rules for testing methods and 4revised5
III. Volume III (Biological Products) Further improve the whole process qualitycontrol requirement of biological products. Supplement and improve the biologicaldetection technology, method and relevanttechnical guidelines.IV. Volume IV(General Rules, Excipients and Packaging Materials) 36 general requirements for preparationsrevised Updated about 15 testing methods and revised30 methods 10 newly increased guidelines and 11 revisedguidelines 65 newly increased standards forpharmaceutical excipients and 212 revisedmethods6
IV. Volume IV(General Rules, Excipients and Packaging Materials) 4 newly increased and revised generaltechnical requirements Having increased indicators in functionalproperties and safety Having updated 16 general testingmethods for drug packaging materialsHarmonization of Chinese Pharmacopoeiaand International Standards(ICH) The purpose of ICH coordination is to ensure the safety,effectiveness, quality and international coordination of medicines. The Chinese Pharmacopoeia refers to the relevant requirementsof the other Pharmacopoeias in the formulation and revision ofthe standards. Fully understand the ICH Q4B standard coordination andstandard implementation, and achieve a balance ofpersonalization and commonality. Further improve the comprehensive evaluation of the ChinesePharmacopoeia and ICH Q4B.7
Harmonization of Chinese Pharmacopoeiaand International StandardsNo.Testing MethodsHarmonization SituationMain DifferencesHarmonizable1Residue on Ignition/Sulphated AshBasically thesamesulfuric acid addition, ignition temperature, and conditionsat the end of the experiment Basically thesamemethod for measuring water for particle inspection,sampling method, and determination result of 100mllabeled amount 2Test for Particulate Contamination:Sub-Visible Particles3Microbiological Examination ofNon-Sterile Products: MicrobialEnumerations TestsBasicallythe samethe test amount is slightly different, and the methodsuitability test and fungal counting medium are slightlysupplemented 4Microbiological Examination ofNon-Sterile Products:Test forSpecified Micro-OganismsBasicallythe samethe source of the strains and bile salt-resistant Gramnegative bacteria have different pre-cultivation times, andChP adds biochemical tests for some control bacteria 5Microbiological Examination ofNon-Sterile Products: AcceptanceCriteria for PharmaceuticalPreparations and Substances forPharmaceutical UseBasicallythe sameChP also includes microbial limit standards for traditionalChinese medicine preparations, traditional Chinesemedicine extracts, and some traditional Chinese medicinedecoction pieces. 6Disintegration TestBasically thesamecontrol the temperature, the number of times the basket islifted, the relevant test parameters, and the results judged method, determination Strains, test numbers, and flushing amounts are slightlydifferent, which slightly complements the sterility methodfor biological products7Uniformity of Dosage Unitsthe sameoverallstructure8Sterility TestBasicallythe same Harmonization of Chinese Pharmacopoeiaand International StandardsNo.9Testing MethodsTablet FriabilityHarmonizationSituationMain DifferencesHarmonizableBasically the sameinstruments and special dosage forms ChP still retains the manual sieving method. ICHmakes more detailed regulations on differentspecifications of sieve types, how to choose asuitable sieve according to the size of the sample,and the weight of the sample 10Analytical SievingBasically the same11Bacterial Endotoxins TestBasically the sameslightly different in method representation 12Dissolution TestPartially consistentmethod, determination. flow cell method notincluded13Test for Extractable Volumeof Parenteral PreparationsBasically the samedifferent sampling methods and specific operations 14Polyacrylamide GelElectrophoresisBasically the sameICH method is more flexible and detailed 15Capillary ElectrophoresisBasically the sameChP is more explicit (separation mode, equipment) 16Bulk Density and TappedDensity of PowdersNot included Based on experimental research, verification and research work, try to beharmonized with international standards8
ChP International CooperationGlobalization of pharmaceutical circulation --harmonization of pharmacopoeia standards globally(promoting import and export trade and eliminatingtechnical barriers)Globalization of pharmaceutical production --- cGMPGlobalization of Drug R & D --- ICH GuidelinesGlobal synchronization of drug registrationdeclarationsDrug Regulatory Cooperation Globalization---Information Sharing, mutual recognition of standardsChP International CooperationOver the past ten years, we have established goodcooperation relationships with pharmacopoeial institutions invarious countries or regions Signed bilateral memorandums of cooperation to graduallypromote the international coordination of drug standards withEDQM,USP,BP,JP, SPRK Chinese medicinal materials, auxiliary materials, packagingmaterials and biological products standards are being jointlyformulated or planned FHH (China, Japan, Korea, Singapore, Vietnam, Australia, HongKong 6 1 International Herbal Forum) Group I:Pharmacopoeia Standard Discussion9
ChP International Cooperation -With WHOChP International Cooperation -With EDQM10
ChP International Cooperation -With USPChP International Cooperation -With BP11
ChP International Cooperation -With JPChP International Cooperation -With SPRK12
Other international cooperation onpharmacopoeia standards2019 International Drug StandardsDevelopment and StandardsCertification was held in Xuzhou City,Jiangsu Province.Workshop on the DevelopmentHistory of Pharmacopoeias was heldin Shandong Province.Welcome to the Pharmacopoeia Museum13
Mr. SHANG,Yueshangyue@chp.org.cnThanks for your attention!14
Harmonization of Chinese Pharmacopoeia and International Standards(ICH) The purpose of ICH coordination is to ensure the safety, effectiveness, quality and international coordination of medicines. The Chinese Pharmacopoeia refers to the relevant requirements of the other Pharmac
study as per IP, API, Unani, Pharmacopoeia, Homoeopathic Pharmacopoeia, Siddha Pharmacopoeia, BHP, Japanese Pharmacopoeia, Chinese Pharmacopoeia, European Pharmacopoeia, USP (dietary supplements), WHO and EMEA guidelines and ESCOP monographs for medicinal products. 07 Unit-4 Quanti
"Pharmacopoeia" may be used to indicate the Pharmacopoeia of the Union. The official texts of the Pharmacopoeia of the Union include general notices, general chapters, monographs, and annexes, which are published in Russian. Monograph is a document that sets out the requirements and statements of the Pharmacopoeia for
Officially recognized pharmacopoeia (or compendium) Those pharmacopoeias recognized by the Authority, i.e., The International Pharmacopoeia (Ph.Int.), European Pharmacopoeia (Ph.Eur.), British Pharmacopoeia (BP), Japanese Pharmacopoeia (JP), and the
c. WHO Monographs on Selected Medicinal Plants d. British Pharmacopoeia e. United States Pharmacopoeia f. Indian Pharmacopoeia g. Chinese Pharmacopoeia h. Natural Standards (www.naturalstandard.com) i. Office of Dietary Supplements, National
Unani Pharmacopoeia of India, Part-II, Vol. III, would be official. If considered necessary these standards can be amended and the Pharmacopoeia Commission for Indian Medicine & Homoeopathy is authorized to issue such amendments. Whenever such amendments are issued, the Unani Pharmacopoeia of India,
The development of this edition had as domumentation sources the European pharmacopoeia existent at that time, the heroic drugs list elaborated by the International Pharmacopoeia Commission (Bruxelles – 1906) and the American Pharmacopoeia. The heroic drugs in the 1915 edition are ma
previous Pharmacopoeia (limited to part of the Name and Standards for the drugs concerned) may be accepted to conform to the Name and Standards established in the new Pharmacopoeia before and on September 30, 2017. In the case of drugs which are listed in the new Pharmacopoeia (excluding those listed in the previous Phar-
Anatomi dan Fisiologi a. Anatomi Tulang Tulang terdiri dari sel-sel yang berada pada ba intra-seluler. Tulang berasal dari embrionic hyaline cartilage yang mana melalui proses “ Osteogenesis ” menjadi tulang. Proses ini dilakukan oleh sel-sel yang disebut “ Osteoblast”. Proses mengerasnya tulang akibat penimbunan garam kalsium. Ada 206 tulang dalam tubuh manusia, Tulang dapat .
