The Pharmacopoeia of the People'sRepublic of China 2015 Edition (hereinafter referred to as the “Chinese Pharmacopoeia”)is the 10th edition of Chinese Pharmacopoeia. All members of the ChinesePharmacopoeia Commission (ChP) and the staff of its permanent institution haveworked diligently to complete the compilation of Chinese Pharmacopoeia 2015 Editionin accordance with the guiding concepts, basic principles, objectives andrequirements set by the Pharmacopoeia Compilation Outline adopted at the FoundingCeremony and Plenary Session of the 10th Chinese Pharmacopoeia Commission underthe leadership of the China Food and Drug Administration (CFDA), the vigoroussupport and assistance of drug control institutions, research institutions anduniversities at various levels, as well as the proactive participation andcoordination of drug manufacturers. On February 4, 2015, the Plenary Session ofthe Executive Committee of the 10th Chinese Pharmacopoeia Commission adoptedthis edition of pharmacopoeia, which was approved by the CFDA on June 5, 2015and came into effect as of December 1, 2015.
The Chinese Pharmacopoeia 2015 Edition comprises Volumes I, II, III and IVand contains a total of 5,608 types of medicinal product, including 1,082 newrevisions. Volume I contains a total of 2,598 types of medicinal materials and theprepared slices of Chinese crude drugs, vegetable, oil fat and extracts, single-itempreparations, etc., including 440 new admissions, 517 new revisions and seven rejections.Volume II contains a total of 2,603 types of chemical drugs, antibiotics,biochemical drugs and radioactive drugs, including 492 new admissions, 415 newrevisions and 28 rejections. Volume III contains a total of 137 biologicalproducts, including 13 new admissions, 105 new revisions and six rejections. Inorder to address such problems as repetitive inclusion of testing methods andlack of coordination, consistency and standardization among various methods,this edition of pharmacopoeia has consolidated the common appendices of variousvolumes of pharmacopoeia and renamed the original appendices into generalrequirements, including general requirements of preparations, testing method,standard substances, reagents and guiding principles. A standard coding systemhas been re-established and for the first time, the general requirements andpharmaceutical excipients have been separately included into Volume IV of theChinese Pharmacopoeia. Volume IV contains a total of 317 general requirements,including 38 general requirements for preparations, 240 for testing methods, 30for guiding principles and nine for standard substances and testing solutionsand reagents; 270 types of pharmaceutical excipients, including 137 newadmissions, 97 new revisions and two rejections.
This edition of pharmacopoeia is characterized by thefollowing features:
The number of included products has been significantlyincreased. The scope of products included has been further expanded toinitially achieve the full coverage of biological products in the Catalogue ofNational Essential Medicines and more than 90% of coverage for TCM and chemicaldrugs. Adjustment has been intensified for certain products with incompletestandards, suspension of manufacturing for many years, excessive clinicaladverse reactions and unreasonable dosage forms. This edition of pharmacopoeiano longer contains a total of 43 products originally included under the 2010edition of pharmacopoeia.
The pharmacopoeia standard system has been further improved. Variousappendices of the previous version of pharmacopoeia have been consolidated intothe Volume IV of this edition of pharmacopoeia. The revision has improved thepharmacopoeia standard system with general notice, general requirements and monographsas overall, basic and specific requirements respectively. For the first time,it has included the guiding principles of “preparation of national pharmaceuticalstandard substances”, “general requirements for pharmaceutical packagingmaterials” and “pharmaceutical glass materials and containers”, and created amore comprehensive pharmacopoeia standard system encompassing drug substancesand their preparations, pharmaceutical excipients, pharmaceutical packagingmaterials and standard substances.
The application of modern analytical technology hasbeen expanded. On the basis of retaining conventional testing methods, thisedition of pharmacopoeia has further expanded the application of newtechnologies and new methods to increase the sensitivity, specificity andstability of testing. The following methods have been employed for the qualitycontrol of TCM, including liquid chromatography, tandem mass spectrometry,high-performance liquid chromatography, inductively coupled plasma massspectroscopy, etc. The following methods of quality control have been employedfor chemical drugs, including supercritical fluid chromatography, criticalpoint chromatography, powder x-ray diffraction, etc. In addition, the newedition of pharmacopoeia has also adopted capillary electrophoresis for the testingof molecular isomers of monoclonal antibody products, and adoptedhigh-performance liquid chromatography for the testing of molecular sizedistribution of antitoxin and antiserum product, etc. For the reserves of testingtechnology, the new version of pharmacopoeia has established method for DNAbarcode molecular identification of Chinese herbal medicine, pigment testingmethod, method for testing of fungal toxin in TCM, near-infrared spectrummethod, drug evaluation technology based on gene chip, etc.
Drug safety assurance has been further improved. Thenew edition of pharmacopoeia has improved “general requirements for medicinalmaterials and the prepared slices of Chinese crude drugs”, “generalrequirements for drug processing” and “general requirements for pharmaceuticalexcipients”; and newly included “general requirements for national standarddrug substances”, “quality control procedure for the raw materials andexcipients of biological product manufacturing”, “general monograph for humanvaccines”, “general monograph for recombinant monoclonal antibody products”, etc,and newly included relevant guiding principles for microparticle preparations,drug crystal form research and crystal form quality control, determination ofthe limits for harmful residues of Chinese herbal medicines. Volume I has setthe limits for sulfur dioxide residues in Chinese herbal medicines and preparedslices of Chinese crude drugs, established the limits for harmful elements inmarine drugs such as pearls and seaweeds, set inspection standards for 16pesticide residues including organic chlorine in ginseng and American ginsengproducts, and newly included the inspection item and limit of “aflatoxin” for14 Chinese herbal medicines and the prepared slices of Chinese crude drugsincluding Platycladi Seed. Volume II has further strengthened the control ofrelevant substances, enhanced the system applicability requirements of methods,and included the structural information of about 500 impurities; included thecontrol of chiral impurity; included osmolarity testing for intravenousinfusion and eye drops and control requirements for bacteriostats in injectionsand eye drops. Volume III has enhanced quality control of raw materials andexcipients for the manufacturing of biological products, standardized the useof antiseptics, and strengthened the control of residual solutions; includedthe osmolarity testing, revised and enlarged the complete genome sequencetesting of virus seed batch, and increased the rigor of bacterial endotoxininspection limits.
Drug efficacy control has been further improved.Testing methods have been revised in a comprehensive manner. Volume I hasincluded the specificity microscopic identification and inspection of Chineseherbal medicines and the testing of characteristic amino acid content, etc;established characteristic spectrums for more than 30 standards including theroot of red-rooted salvia. Volume II has adopted iron chromatography for thetesting of acid group content in sulfate or hydrochloride drug substances;adopted methods with greater specificity and accuracy for the testing ofpreparation content; revised and enlarged the methods for the inspection of thesolution and releasing rates, and strengthened control of oral solid dosageforms and sustained-release preparations.
Standards for pharmaceutical excipients have beensignificantly improved. This edition of pharmacopoeia has included multiplespecifications of pharmaceutical excipients in series to meet the needs ofpreparations manufacturing. 21 types of injection-grade excipients have beennewly included. Safety control has been enhanced for pharmaceutical excipientssuch as inclusion of control requirements for residual solutions. Greaterattention has been paid to the functional control of excipients. For instance,such inspection items as multi-porosity, powder fineness, powder flowability,specific surface area and viscosity have been included and the requirements forthe research of applicability of standards for pharmaceutical excipients havebeen enhanced.
Guiding effect of pharmacopoeia has been furtherstrengthened. Guiding effect of this edition of pharmacopoeia for drug qualitycontrol has been enhanced through the screening and adjustment of products, admissionof advanced testing methods and formulation of technical guidelines; meanwhile,in light of the tendencies of international drug quality control and standardizationand the realities of drug manufacturing in China, equal emphasis has been givento the safety and accessibility of medications in the configuration ofinspection items and limits in order to guide the sound and science-baseddevelopment of pharmaceutical industry in China.
This edition of pharmacopoeia continues to follow theconcepts of protecting the wildlife and environment and adhering to thesustainable development and promotion of green standards for TCM. For instance,newly included prescriptions no longer contain the Chinese patent medicines ofendangered species or fossils such as leopard bone, antelope’s horn, fossilfragments and dens draconis; replacements of toxic solutions in testingreagents are advocated, e.g., the use of reagents containing benzene andmercury is abolished in order to reduce pollution to the environment andlaboratory personnel.
The new edition of pharmacopoeia has been drafted in amore open, transparent, standardized and orderly manner. Drafting process ofthis edition of pharmacopoeia has always adhered to the principles of openness,fairness and justice. The permanent institution of the Chinese Pharmacopoeia Commission(ChP) has introduced the ISO9001 quality management system into the whole-processmanagement of pharmacopoeia drafting, continuously improved administrativesystem for the Chinese Pharmacopoeia Commission (ChP) and standardized workingprocedure for pharmacopoeia drafting to ensure the quality of pharmacopoeiadrafting process. The Chinese Pharmacopoeia Commission (ChP) has vigorouslypromoted drug standards and scientific research to ensure the progress and qualityof pharmacopoeia drafting. Efforts have been made to strictly follow the “workingprocedure for the drafting of Chinese pharmacopoeia”, improve the communicationand coordination among professional committees, and enhance the review andpublication of standards. All the additions and revisions of standards havebeen published at the website of the Chinese Pharmacopoeia Commission (ChP) andthe results of expert review and feedback opinions have been published as well.
On the basis of maintaining scientificity and standardizationof pharmacopoeia, this edition of pharmacopoeia emphasizes on enhancing thecontrol requirements of drug safety and efficacy, referencing internationallyadvanced quality control technologies and experiences, improving the level ofthis edition of pharmacopoeia, and reflecting China's current pharmaceuticaldevelopment and testing technologies. It will play an important role inpromoting China's drug quality improvement, accelerating corporate technologyprogress and product upgrades, expediting the healthy development of China'spharmaceutical industry and increasing the authoritativeness and internationalinfluence of the Chinese pharmacopoeia.