On March 28, 2014, the official website of the State Pharmacopoeia Commission published a notice on the public solicitation of opinions on the “General Amendments to the 2015 Pharmacopoeia†(Draft). According to the notification, the relevant professional committees of the National Pharmacopoeia Commission have completed the research on the preparation and coding of the General Regulations (Appendix), and in January 2014, they passed the pharmacopoeia forum of the State Pharmacopoeia Commission's official website to seek the opinions of all pharmacopoeia members.
The original of the notice is as follows:
Notice on Public Consultation on the General Regulations for the 2015 Pharmacopoeia (Draft)
All relevant units:
According to the requirements of the “2015 edition of the Chinese Pharmacopoeiaâ€, the Committee has organized related professional committees to carry out the integration, addition, and revision of the appendixes of the pharmacopoeia 1, 2 and 3, and separate roll-up work. Through the efforts of the relevant professional committees and the strong cooperation of the relevant units, the research work on the preparation and coding of the General Principles (Appendix) has been completed. In January 2014, the Pharmacopoeia Forum on the website of the Committee of the CPC Committee was invited to seek the opinions of all Pharmacopoeia members. Based on the feedback and suggestions, the overall framework and content of the "China Pharmacopoeia" 2015 General Regulations (Draft) has been formed. The relevant matters are now notified and explained as follows:
I. To further improve the contents of the new edition of the Pharmacopoeia, the Committee will publicly solicit opinions on the overall framework of the Pharmacopoeia (draft) and the general contents of the Pharmacopoeia (draft for solicitation of opinions) on the website in batches. The first batch of drafts for consultation will be publicized. The public notice period is three months.
2. The name of an independent volume is the "2015 Pharmacopoeia General Principles" of the Chinese Pharmacopoeia, including the appendices of the existing Pharmacopoeia 1, 2, and 3, and the texts of varieties of medicinal excipients (see Annex 1 for details).
Third, the general code is intended to be represented by the two-level four-digit Roman numerals “XXYYâ€, where XX represents the large Roman alphabet (I, II, III, ...) encoded in the existing appendix, and YY represents the English alphabet coded in the existing appendix (A , B, C...). Please refer to Appendix 2 for the details of the old and new appendices/general rules.
4. According to the text integration and experimental studies, the completed general draft of amendments is detailed in Annex 3. Please check the relevant units carefully. If you have any objections, you can fill in the feedback form (see Annex 4.), and attach relevant instructions and/or experimental data. Feedback from the letter or email is provided to the Committee. The unfinished content of the amendment will be announced in the second batch.
5. In order to guarantee the smooth implementation of the 2015 edition of the Chinese Pharmacopoeia, the Committee will publish the general contents of the Pharmacopoeia on the Internet and compile it into a book. In April 2014, the Committee will hold a seminar on the amendments to the new Pharmacopoeia General Regulations. In order to allow the majority of drug standards workers to better understand the preparation of the 2015 edition of the "Chinese Pharmacopoeia", please pay attention.
6. Contacts and Contact Information:
Xu Huayu (Tel: 010–67079521)
Gui Guimin (Tel: 010–67079527)
Hong Xiaoyi (Tel: 010-67079593)
Fax: 010–67152769
E-mail:
annex:
1. "China Pharmacopoeia" 2015 version of the general (draft)
2. Old and new appendices/general rules encoding table
3. The "Chinese Pharmacopoeia" 2015 version of the general catalog and additional content
General 0100 preparations
0101 tablets
0102 Injection
0103 Capsules
0104 Granules
0105 Ophthalmic formulation
0106 nasal preparation
0107 suppository
0108 Ointment
0109 Cream
0110 paste
0111 Inhalation preparation
0112 Spray
0113 aerosol
0114 gel
0115 Powder
0116 drops of pills
0117 Sugar Pills
0118 syrup
0119 tincture
0120 coating agent
0121 coating agent
0122 tincture
0123 patch
0124 plaster
0125 Oral solution Oral suspension Oral emulsion
0126 implant
0127 film agent
0128 ear preparations
0129 lotion
0130 Rinse
0131 enema
0181 pills
0182 mixture
0183 lozenges
0184 Decoction (Ointment)
0185 glue
0186 liquor
0187 stream extracts and extracts
0188 Plaster
0189 Lotion
0190 Tea
0200 other general rules
0211 Medicinal materials and decoction sampling method (unmodified)
0212 General Rules for the Examination of Medicinal Herbs and Herbs (Second Supplement)
0213 General Rules (unmodified)
0251 General rules for medicinal excipients
0261 Pharmaceutical Water
0271 general rules for drug packaging (to be determined)
0272 glass container (to be determined)
0291 General Principles of National Drug Standard Materials (Second Supplement)
0300
0301 General Identification Test (Second Supplement)
0400 spectroscopy
0401 UV-Vis Spectrophotometry
0402 Infrared spectrophotometry
0405 fluorescence spectrophotometry
0406 Atomic Absorption Spectrophotometry
0407 Flame photometry
0411 Inductively Coupled Plasma Atomic Emission Spectrometry
0412 Inductively Coupled Plasma Mass Spectrometry (Updated)
0421 Raman Spectroscopy (New)
0431 Mass Spectrometry
0441 Nuclear Magnetic Resonance Spectroscopy
0451 X-ray diffraction
0500 Chromatography (unmodified)
0501 paper chromatography
0502 TLC
0511 Column Chromatography (unmodified)
0512 HPLC
0513 Ion Chromatography
0514 size exclusion chromatography
0521 Gas Chromatography
0531 Supercritical Fluid Chromatography (to be added)
0532 Critical Point Chromatography (to be added)
0541 electrophoresis
0542 Capillary Electrophoresis
0600 physical constant method
0601 Relative Density Determination (unmodified)
0611 Distillation Method
0612 melting point method
0613 freezing point assay
0621 Polarimetry
0622 refractive index method (unmodified)
0631 pH Measurement
0632 Osmolality assay
0633 viscosity method
0661 Thermal Analysis (Second Supplement)
0681 Determination of conductivity of pharmaceutical water (unmodified)
0682 Total Organic Carbon Determination in Pharmaceutical Water (Unrevised)
0700 Other assays Other Assays
0701 Potentiometric Titration and Perpetual Stop Titration (Unrevised)
0702 Non-aqueous titration
0703 Oxygen cylinder combustion (unmodified)
0704 Nitrogen Measurement
0711 Ethanol assay
0712 Methoxy, Ethoxy, and Hydroxypropyloxy Assays (Unrevised)
0713 Fatty and fatty oil assays (unmodified)
0721 Vitamin A Assay (Not Revised)
0722 Vitamin D Assay (Not Revised)
0731 Protein Content Assay
0800 limited inspection method
0801 Chloride Inspection (Not Revised)
0802 Sulfate Inspection Method (Unrevised)
0803 Sulphide Inspection (Not Revised)
0804 Selenium Test (Not Revised)
0805 Fluoride Inspection Method (Not Revised)
0806 cyanide inspection method
0807 iron salt inspection method (unmodified)
0808 ammonium salt inspection method (second supplement)
0821 Heavy Metal Inspection (First Supplement)
0822 Arsenic Salt Inspection Method (Not Revised)
0831 Loss on drying test
0832 Moisture Determination
0841 Residue on ignition test (second supplement)
0842 easy char method (unmodified)
0861 Residual Solvent Assay (Not Revised)
0871 methanol test method
Determination of Acetic Acid in 0872 Synthetic Peptides (Unrevised)
0873 2-ethylhexanoic acid assay (unmodified)
0900 physical characteristics inspection method
0901 solution color inspection
0902 Clarity Check
0903 Insoluble particle inspection method
0904 visible foreign matter inspection method
0921 disintegration time limit test
0922 fusion time limit test (unmodified)
0923 tablet friability test (unmodified)
Dissolution method 0931 (combined release assay)
0941 Content uniformity test method
0942 minimum loading inspection method
0951 AERODYNAMIC EVALUATION METHOD FOR INHALED POLYMER MICROPARTICLES (ORIGINAL DROPLET DISTRIBUTION MEASUREMENT)
0952 Adhesive strength measurement method
0981 Crystallinity Test (Not Revised)
0982 Particle Size and Size Distribution Determination (First Supplement)
0983 cone penetration test
1000 Molecular Biology Technology
1001 nucleic acid molecular identification method (to be determined)
1100 bioassay
1101 sterility test
1105 Microbial limit test for non-sterile products: Microbiological counting
1106 Microbial limit test for non-sterile products: Control bacteria inspection method
1107 Microbiological limits for non-sterile drugs
1121 Antimicrobial efficacy test (third supplement, new)
1141 Abnormal toxicity test
1142 pyrogen test
1143 bacterial endotoxin test
1144 Boost substance inspection method
1145 Decompression Substance Inspection Method (Unrevised)
1146 Histamine Inspection (Additional)
1147 Allergy Test (Not Revised)
1148 hemolysis and coagulation test
1200 bioactivity assay
1201 antibiotic microbial assay (unmodified)
1202 Penicillinase and its activity assay (unmodified)
1205 vasopressin bioassay
1206 Cytochrome C Activity Assay (unmodified)
1207 Glass Enzyme Assay (Unrevised)
1208 Heparin Bioassay (third supplement)
1209 Choriokinin Bioassay
1210 oxytocin bioassay
1211 Insulin bioassay (unmodified)
1212 Protamine Zinc Insulin Injection Delay Action Test (Unrevised)
1213 Protamine Sulfate Bioassay (unmodified)
1214 Digitalis Bioassay (unmodified)
1215 Sodium Gluconate Sodium Virucity Test (Not Revised)
1216 Follicle Stimulating Hormone Bioassay
1217 Lutein Bioassay
1218 Calcitonin Bioassay
1219 Growth Hormone Bioassay (unmodified)
1401 Radioactive Drug Testing Act (unmodified)
1421 Sterilization (unmodified)
1431 Biometric Statistics Method (Unrevised)
2000 Chinese medicine related examination methods
2001 microscopic identification method (second supplement)
2002 Chinese herbal medicine DNA barcode molecular identification method (new)
2101 Expansion Method (Second Supplement)
2102 Plaster Softening Point Method (Unrevised)
2201 Leachate Assay (unmodified)
2202 Tannin content assay (second supplement)
2203 Determination of olein content (unmodified)
2204 Volatile Oil Assay (Not Revised)
2301 Medicinal materials and decoction impurities inspection method
2302 Ash Determination (unmodified)
2303 rancidity assay (unmodified)
2321 Determination of lead, cadmium, arsenic, mercury, copper (unmodified)
2322 Elemental Forms and Determination of Their Valences (to be added)
2331 Sulfur dioxide residue assay
2341 Determination of Pesticide Residues (Second Supplement + Update)
2351 Aflatoxin Assay (2nd Supplement + Update)
2400 Inspection Method for Related Substances of Traditional Chinese Medicine Injection (Proposed Revision)
2401 Chinese medicine injection protein examination method (to be determined)
2402 Chinese Herbal Injection Qualitative Examination (to be determined)
2403 Chinese medicine injection resin inspection method (to be determined)
2404 Herbal Injection Oxalate Test (to be determined)
2405 Potassium ion test method for traditional Chinese medicine injection (to be determined)
2406 Chinese medicine injection polymer polymer inspection method (to be determined)
3000 bio-product related inspection methods (to be determined)
3100 assay
3101 Total solids determination
3102 Sialic acid assay
3103 Phosphorus assay
3104 ammonium sulfate assay
3105 sodium bisulfite assay
3106 aluminum hydroxide (or aluminum phosphate) assay
3107 Sodium Chloride Assay
3108 citrate ion assay
3109 sodium octanoate assay
3110 acetyl tryptophan assay
3111 phenol assay
3112 m-cresol assay
3113 Thimerosal assay
3114 Determination of Methylparaben and Propylparaben
3115 O-Acetyl assay
3116 Adipic hydrazide content assay
3117 Polymer conjugate content assay
3118 Human blood products sugar and sugar alcohol assay
3119 Human Albumin Multimer Assay
3120 human immunoglobulin products IgG monomer plus dimer assay
3121 Human Immunoglobulin Glycine Content Assay
3122 recombinant human granulocyte stimulating factor protein assay
3123 histamine human immunoglobulin free histamine assay
3124 IgG Content Assay
3200 chemical residue assay
3201 ethanol residue assay
3202 polyethylene glycol residue assay
3203 polysorbate 80 residue assay
3204 glutaraldehyde residue assay
3205 tributyl phosphate residual assay
3206 Carbodiimide (EDAC) Residue Measurement
3207 free formaldehyde assay
3208 human serum albumin aluminum residue assay
3300 microbiological examination
3301 Mycoplasma Test
3302 Exogenous Factor Test
3303 Mouse-borne virus test
3400 bioassay
3401 immunoblotting
3402 immunospot assay
3403 double immunodiffusion assay
3404 immunoelectrophoresis
3405 Peptide Mapping
3406 plasmid loss rate test
3407 SV40 Nucleic Acid Sequence Test
3408 exogenous DNA residue assay
3409 Antibiotic residue test method (culture method)
3410 Kallikrein Activator Assay
3411 Anti-complement activity assay
3412 bovine serum albumin residue assay
3413 E.coli bacterial protein residue assay
3414 Pseudomonas bacteria protein residue assay
3415 Yeast Engineering Protein Residue Protein Assay
3416 class A blood type substance assay
3417 murine IgG residue assay
3418 Acellular Pertussis Vaccine Identification Test (Enzyme Linked Immunosorbent Assay)
3419 Antitoxin, antiserum product identification test (enzyme immunoassay)
Determination of the molecular size of meningococcal polysaccharide 3420 Group A
3421 Typhoid Vi Polysaccharide Molecular Size Assay
Method for determination of polysaccharide content of Haemophilus influenzae 3422 b conjugate vaccine
3423 Human Thrombin Activity Test
3424 activated coagulation factor activity test
3425 Heparin Content Assay
3426 anti-A, anti-B hemagglutinin assay
3427 human erythrocyte antibody assay
3428 Human Platelet Antibody Assay
3429 Monkey Body Neurotoxicity Test
3500 bioactivity/valence assay
3501 Recombinant Hepatitis B Vaccine (Yeast) In Vitro Relative Potency Test
3502 In Vitro Relative Potency Test of Inactivated Hepatitis A Vaccine
3503 human rabies vaccine titer assay
3504 adsorption tetanus vaccine titer assay
3505 adsorption diphtheria vaccine titer assay
3506 toxoid floc unit assay
3507 diphtheria antitoxin titer assay
3508 Tetanus antitoxin titer assay
3509 gas gangrene antitoxin titer assay
3510 botulinum antitoxin titer assay
3511 anti-venom serum titer assay
3512 Rabies immunoglobulin titer assay
3513 diphtheria antibody titer assay in human immunoglobulin
3514 Human Immunoglobulin Fc Section Biological Activity Assay
3515 Anti-human T-cell immunoglobulin titer assay (E rose wreath formation inhibition test)
3516 Anti-human T-cell immunoglobulin titer assay (lymphocyte toxicity test)
3517 human coagulation factor II titer assay
3518 human coagulation factor VII titer assay
3519 human coagulation factor IX titer assay
3520 human coagulation factor X titer assay
3521 human coagulation factor VIII titer assay
3522 Recombinant human erythropoietin in vivo biological activity assay
3523 Interferon Biological Activity Assay
3524 Recombinant Human Interleukin-2 Biological Activity Assay
3525 Recombinant Human Granulocyte Stimulating Factor Biological Activity Assay
3526 Recombinant human granulocyte macrophage stimulating factor biological activity assay
3527 recombinant bovine basic fibroblast growth factor biological activity assay
3528 recombinant human epidermal growth factor biological activity assay
3529 recombinant streptokinase biological activity assay
3600 Specific Biological Raw Materials/Animals
3601 Specific pathogen-free chicken embryo quality testing requirements
3602 Laboratory Animal Microbiological Testing Requirements
3603 Laboratory Animal Parasitology Test Requirements
3604 newborn calf serum test requirements
3611 Bacterial Biochemical Reaction Medium
8000 Reagents and Reference Materials (TBD)
8001 reagent
8002 test solution
8003 test paper
8004 buffer
8005 indicator and indicator liquid
8006 titrant
8061 reference material
9000 guidelines
9001 Guidelines for Stability Testing of Raw Materials and Pharmaceutical Preparations (to be determined)
9011 Guidelines for human bioavailability and bioequivalence testing of pharmaceutical preparations (to be determined)
9012 Guiding Principles for Quantitative Analysis of Biological Samples (TBD)
9013 Sustained Release, Controlled Release and Delayed Release Preparation Guidelines (Unrevised)
9014 Particle Formulation Guidelines (TBD)
9015 injection preparation guidelines (to be added, pending)
9101 Guidelines for Validation of Analysis Methods for Drug Quality Standards
9102 Drug impurity analysis guidelines
9103 Drug Hydration Test Guidelines (Not Revised)
9104 Near-Infrared Spectrophotometry Guidance (Unrevised)
Guidelines for Quality Control Techniques and Methods for 9105 Polymorphic Drugs (New)
9106 Technical Guidelines for Evaluation of Drug Safety and Effectiveness Based on Gene Chip Technology (New)
9201 Guidelines for Validation of Alternative Methods for the Examination of Microorganisms of Drugs (Unrevised)
9202 Microbial Limit Test Application Guidelines
9203 Guidelines for Quality Management of Pharmaceutical Microbiology Laboratory (third supplement)
9204 Guidelines for Microbiological Identification (New)
9205 Guiding Principles for Microbiological Surveillance and Control of Drug Cleaning Laboratories (New)
9206 Segregation System Verification Guidelines for Aseptic Inspection (New)
9301 injection safety inspection application guidelines
9302 Guidelines for the Establishment of Limitations of Hazardous Residues (New)
9401 Guiding Principles for Determination of Biological Activity of Chinese Herbs
9501 Guidelines for Quality Control of Positron-type Radioactive Drugs (Unrevised)
9502é”99mTc Radiopharmaceutical Quality Control Guidelines (Not Revised)
9701 Guiding Principles for the Study of Performance Indicators for Pharmaceutical Excipients (Third Supplement, Proposed Addition)
9901 National Drug Reference Material Preparation Guidelines (Second Supplement)
Schedule Atomic Scale (unmodified)
Schedule of International Unit Conversion Form (to be confirmed)
4. Feedback Draft for Exposure Draft
National Pharmacopoeia Committee
March 28, 2014