The Chinese Pharmacopoeia Commission (ChP)
2015 edition (10th edition): In December 2010, the10th Chinese Pharmacopoeia Commission was established by the State Food andDrug Administration (renamed into the China Food and Drug Administration onMarch 22, 2013). In accordance with the newly revised Measures for the Screening of New Members and Working Scheme for the Screening of the 10th Chinese PharmacopoeiaCommission (ChP), the Chinese Pharmacopoeia Commission (ChP) openlysolicited membership candidates from the public and adopted competitiveelections and secret ballots for the election of new members. This Commissionhas a total of 351 members, of whom 248 are re-appointed and 103 are newlyappointed. The then Vice-Chairman of the Standing Committee of the 11thNational People's Congress Sang Guowei serves as the honorary director member,the then Health Minister Chen Zhu serves as director member, and the then ViceHealth Minister and CFDA Minister Shao Ming serves as executive deputy directormember. This Commission has an executive committee and 23 professional committees.The executive committee has a total of 67 members, including 28 academician members,three senior experts, 20 directors of various professional committees, fourexperts from relevant ministries and commissions, and seven leaders of relevanttechnical agencies of the CFDA. In accordance with the needs of pharmacopoeia standardizationwork, this term of Commission has made appropriate adjustments to the creationof professional committees on the basis of the configuration of the ninthChinese Pharmacopoeia Commission (ChP); in order to enhance the drafting ofchemical drug standards, the Third Professional Committee for Chemical Drugshas been established and the number of members on the chemical drug committeeshas been increased; meanwhile, in light of actual needs, the Policy and DevelopmentCommittee, Standard Information Working Committee and Injection WorkingCommittee have been abolished.
In December 2010, the Founding Ceremony and PlenaryConference of the 10th Chinese Pharmacopoeia Commission (ChP) was held. Theconference deliberated and adopted the Compilation Outline for the Chinese Pharmacopoeia2015 Edition, which specified guiding concepts, basic principles, developmentobjectives and main tasks for the drafting of the Chinese Pharmacopoeia 2015Edition.
In accordance with the requirements of the 12thFive-Year Plan of National Drug Safety, the National Pharmacopoeia Commission(ChP) has organized various professional committees and relevant institutionsto carry out the drafting work of pharmacopoeia on the basis of implementingthe “action plan for national drug standard enhancement.” The permanentinstitution of the Chinese Pharmacopoeia Commission has introduced the ISO 9001quality management system into the whole-process management of pharmacopoeiadrafting, and conducted various activities including product screening, projectinitiation, trials and research, standard drafting, review and finalization,and steadily advanced various tasks for the drafting of this edition ofpharmacopoeia. On February 4, 2015, the Chinese Pharmacopoeia 2015 Edition wasapproved by the Plenary Session of the Executive Committee of the 10th ChinesePharmacopoeia Commission and on June 5, 2015, approved and enacted by the CFDAfor official implementation as of December 1, 2015.
This edition of pharmacopoeia has further expanded theadmissions and revisions of drug products, with a total of 5,608 admissions.Volume I contains 2,598 admissions, including 440 new admissions, 517 revisionsand seven rejections. Volume II contains 2,603 admissions, including 492 newadmissions, 415 revisions and 28 rejections. Volume III contains 137admissions, including 13 new admissions, 105 revisions, one newly added chaptergeneral requirement for biological products, three newly added generalmonographs for biological products, and six rejections. For the first time,this edition of pharmacopoeia has consolidated the appendices of the previousedition of pharmacopoeia into the general requirements and includedpharmaceutical excipients as a separate Volume IV of the Chinese Pharmacopoeia.Volume IV contains 317 general requirements, including 38 general requirementsfor preparations, 240 for testing methods (including 27 new admissions), 30guiding principles (including 15 new admissions), as well as nine generalrequirements for standard products, standard substances and test solutions andsubstances. A total of 270 types of pharmaceutical excipients have beencontained, including 137 new admissions, 97 revisions and two rejections.
This edition of pharmacopoeia has improved thedevelopment of pharmacopoeia standard system, enhanced quality controlrequirements in a comprehensive manner, further expanded the application ofadvanced and sophisticated testing techniques, greatly increased the number ofadmissions of pharmaceutical excipients, increased the rigor of qualityrequirements and safety control, and thus further enhanced the guiding andtechnology orientation effects of the Chinese Pharmacopoeia.
In the process of drafting this edition ofpharmacopoeia, we have also completed the revision of the First, Second andThird Addendums to the 2010 Edition of the Chinese Pharmacopoeia, the Atlas of InfraredSpectra of Drugs (Volume 5), China Approved Drug Names, Working Handbook of NationalDrug Standards (Fourth Edition) and the Annotations of the ChinesePharmacopoeia, and organized the drafting of the English version of ChinesePharmacopoeia 2015 Edition and the Instructions for Clinical Medications 2015Edition.