Chinese Pharmacopoeia Commission

2015-09-17

Institutionalfunctions

The Chinese Pharmacopoeia Commission (ChP) is established in accordance with theApproval of the State Commission Office of Public Sectors Reform (SCOPSR) forthe Establishment of Institutions Affiliated to the China Food and DrugAdministration (CFDA) (SCOPSR Approval [2013] No.93) as a directly affiliated institutionof the CFDA (bureau-level).

I. Mainresponsibilities

(1)Organize the drafting and revision of the Pharmacopoeia of the People’sRepublic of China (hereinafter referred to as the “Chinese Pharmacopoeia”) andits addendums.

(2)Organize the drafting and revision of national drug standards and qualitystandards for pharmaceutical excipients, packaging materials in direct contactwith drug substances, as well as containers.

(3)Participate in the evaluation of the performance of the Chinese Pharmacopoeiaand national drug standards.

(4)Be responsible for the communication, training and technical consultation ofthe Chinese Pharmacopoeia and national drug standards.

(5)Participate in the drafting of management systems for the standards of medications,pharmaceutical excipients, packaging materials in direct contact with drugsubstances, as well as containers, and establish and improve drug standardmanagement system and relevant working mechanisms.

(6)Organize the conduct of research and drug standardization strategies, drugstandard management policies and technical regulations, and undertake theanalysis and evaluation tasks of pharmaceutical and medical clinicalinformation.

(7)Carry out international communication and cooperation related to drugstandards, and participate in the international drug standard applicabilitycertification cooperation and the drafting and revision of international drugstandards.

(8)Be responsible for the drug standard information development.

(9)Be responsible for organizing the editing, publishing and distribution ofpublications and journals including the Chinese Pharmacopoeia series and DrugStandards of China.

(10)Be responsible for the organization, coordination and service assurance ofrelevant working conferences of the pharmacopoeia commission in accordance withthe Charter of the Pharmacopoeia Commission.

(11)Undertake other tasks assigned by the CFDA.

II. Internal institutions

Based on the aforesaid main responsibilities, the ChinesePharmacopoeia Commission (ChP) has created the following nine internal bodies:

(1) AdministrativeOffice (Party Commission Office)

Tocarry out the general management of the institution’s administrative affairs,and be responsible for such activities as general document drafting, conferenceorganization, handling of official documents, document archiving, governmentinformation, yearbook drafting, supervision, security confidentiality, fixedasset management, as well as completion of social statistics forms. Beresponsible for such activities as the institution’s financial management,logistical service assurance and comprehensive coordination of emergencymanagement. Undertake other tasks assigned by the institution.

(2) Division of GeneralAffairs

Toundertake the general management activities of the institution’s serviceaffairs, and coordinate the technical work of various business divisions. Beresponsible for organizing the drafting, supervision and implementation ofworking plan for national drug standards and technical guidelines for nationaldrug standards. Organize the drafting, revision and interpretation of the generalprinciples, general rules and guidelines of the Chinese Pharmacopoeia, as wellas the translation of its English edition. Organize the drafting of theaddendums to the Chinese Pharmacopoeia. Participate in the evaluation of theimplementation of the Chinese Pharmacopoeia and national drug standards. Beresponsible for organizing the implementation of drug standard informationdevelopment, and undertake the institution’s development, maintenance andmanagement activities. Undertake the institution’s foreign affairs managementand service activities. Organize the drafting and revision of technicalrequirements and quality standards for pharmaceutical excipients and packagingmaterials and containers in direct contact with drug substances. Be responsiblefor coordinating the organization and preparation of the Chinese PharmacopoeiaCommission’s general assembly and executive committee meetings. Be responsiblefor the organization and coordination of comprehensive special committeemeetings. Undertake other tasks assigned by the institution.

(3) Division of TCM Standards

Tobe responsible for organizing the drafting and revision of TCM nationalstandards. Be responsible for organizing the drafting of the ChinesePharmacopoeia Volume 1. Be responsible for the naming of general names of TCMproducts. Be responsible for the technical review of standards of imported TCMmaterials. Be responsible for organizing the translation of the English versionof the Chinese Pharmacopoeia. Participate in the drafting of Chinese Pharmacopoeiaseries. Participate in the naming of general names of TCM products. Beresponsible for the technical review of imported TCM standards. Be responsiblefor the interpretation and technical consultation of TCM national standards. Beresponsible for the organization and coordination of relevant TCM specialcommittee meetings. Undertake other tasks assigned by the institution.

(4) Division of ChemicalDrug Standards

Tobe responsible for the drafting and revision of chemical drug nationalstandards. Be responsible for organizing the drafting of the ChinesePharmacopoeia Volume 2. Be responsible for organizing the translation of the Englishversion of the Chinese Pharmacopoeia Volume 2. Participate in the drafting ofthe Chinese Pharmacopoeia series. Be responsible for the naming of the generalnames of chemical drugs. Be responsible for the interpretation and technicalconsultation of national standards for chemical drug. Be responsible fororganizing and coordinating relevant special committee meetings on chemicaldrugs. Be responsible for other tasks assigned by the institution.

(5) Division of BiologicalProduct Standards

Tobe responsible for the drafting and revision of national standards andbiological products. Be responsible for the drafting of the Chinesepharmacopoeia volume 3. Be responsible for the translation of the Englishedition of the Chinese pharmacopoeia volume 3. Participate in the drafting ofthe Chinese pharmacopoeia series. Be responsible for the naming of the generalnames of the biological products. Be responsible for the interpretation andtechnical consultation of national standards and biological products. Beresponsible for the organization and coordination of relevant special committeemeetings on biological products. Undertake other tasks assigned by theinstitution.

(6) Division of QualityManagement (Research Office)

Toorganize the drafting and revision of the institution’s quality managementsystem documents and supervise their implementation. Organize the conduct ofinternal review and management review activities of drug standard and qualitymanagement system on a regular basis. Participate in the drafting of managementsystems for drug products, pharmaceutical excipients, and packaging materialsand containers in direct contact with drug substances, and establish andimprove the management system of drug standards and relevant workingmechanisms. Follow up domestic and international developments of drug standardization,and participate in the drafting of drug standardization strategies, and drugstandard management policies and technical regulations. Undertake other tasksassigned by the institution.

(7) Division of Personnel

Tobe responsible for drafting the management rules and systems of the institutionand organizing their implementation. Undertake the supervision of theinstitution’s internal organization, personnel management and cadres’supervision. Undertake such activities as the institution’s personnelperformance evaluation, awards and penalties, training and remuneration, socialinsurance and management, et cetera. Be responsible for the daily attendancemanagement of the institution’s personnel and the management and serviceactivities for retirees. Be responsible for the management and serviceactivities for the institution’s temporary contractors, secondees,trainings and interns. Be responsible for other tasks assigned by theinstitution.

(8) Division of Medical Evaluation

Tobe responsible for organizing the screening of pharmaceutical products includedin the Chinese Pharmacopoeia. Organize the analysis and evaluation ofpharmaceutical and medical information to provide comprehensive clinicalmedication information for the screening of drug products. Participate indrafting the Chinese Pharmacopoeia series. Be responsible for the interpretationand technical consultation of drug and medical information. Be responsible forthe naming of the general names of TCM products. Be responsible for organizingand coordinating relevant special medical committee meetings. Undertake othertasks assigned by the institution.

(9) Division of communication and exchange

Toorganize the implementation of the communication and training of national drugstandards and relevant information. Organize relevant business developmentactivities and undertake the organization and coordination of the applicabilitycertification of international drug standards. Undertake the management andassurance of the institution’s business meetings. Be responsible for thepublication and distribution of national drug standards and supporting standardseries and its electronic version. Be responsible for the editing, publishingand distribution of the drug standards of China magazine. Organize relevantacademic exchanges, communication and media coverage of drug standards.Undertake other tasks assigned by the institution.

Profiles ofleaders

Profileof Secretary General: Zhang Wei

Zhang Wei, male,ethnic Han, was born in August 1959. He entered workforce in August 1982 and isa member of the Communist Party of China (CPC). He holds a Master Degree inBusiness Administration and is a professor of pharmacy. He served at thefollowing positions over the years: Inspector, Deputy Director of ClinicalChemistry, Assistant Director and Deputy Director of Beijing Institute for DrugControl, Deputy Director of the Division of Pharmaceutical Affairs of BeijingHealth Bureau, Director of Beijing Institute for Drug Control, member of theParty Organization and Deputy Director of Beijing Food and Drug Administration,and Director-General of the Drug Registration Department of the CFDA(Department of TCMs and Ethno-Medicines Supervision). Since October 2012, he hasbeen serving as the Secretary General and Deputy Party Secretary of the ChinesePharmacopoeia Commission (ChP).

Profileof Deputy Secretary-General: Lan Fen

Lan Fen, male,ethnic Miao, was born in July 1964 and entered workforce in August 1985. He isa member of the Communist Party of China (CPC) and holds a Bachelor of ScienceDegree. He served the following positions over the years: Research assistantand research associate of the People’s Liberation Army (PLA) Institute ofChemical Defense, research associate, senior engineer and Director of DrugScreening Office of the Pharmaceutical Affairs Department of the ChinesePharmaceutical Association, Director of the Essential Drugs Division of theCenter for Drug Evaluation (CDE) of the CFDA, Deputy Director, Investigator andDirector of the Division of Pharmacovigilance and Drug Evaluation of theDepartment of Drug Safety Supervision of the CFDA, and Director of the Divisionfor the Supervision of Special Drugs of the Department of Drug and CosmeticsSupervision of the CFDA. Since June 2014, he has been serving as the DeputySecretary-General of the Chinese Pharmacopoeia Commission (ChP).

Organizationalchart

Founded in 1950,the Chinese Pharmacopoeia Commission (formerly the Pharmacopoeia Commission ofthe Ministry of Health) is responsible for organizing the drafting of the Pharmacopoeiaof the People’s Republic of China and instituting and revising national drugstandards in accordance with the provisions of the Drug Administration Law ofthe People’s Republic of China. It is the statutory professional institution forthe management of national drug standards.

The permanentinstitution of the Chinese Pharmacopoeia Commission is headed by a Secretary-Generaland has established such divisions and offices as the Administrative Office,the Division of Personnel, the Division of General Affairs, the Division of PharmaceuticalInformation, the Division of TCM, the Division of Chemical Drugs, as well asthe Division of Biological Products, together with affiliates including the DrugStandards of China magazine. The permanent institution of the Chinese PharmacopoeiaCommission has a personnel quota of 50 people and currently employs about 90 people(including contractors and affiliates).

Internal Institutions of theChinese Pharmacopoeia(Commission) (ChP)


Contact us

Contact method:

Address:Building No.11, Fahua Nanli, Tiyuguan Road, Beijing

Postcode: 100061

Telephone:0086-10-67079644

Fax:0086-10-67152766

Email: chpc@chp.org.cn

Payment method:

Account name:Chinese Pharmacopoeia Commission (“国家药典委员会”)

Account number:0200008109089270084

Bank of deposit:Beijing Tiyuguan Road Branch of the Industrial and Commercial Bank of China(ICBC)

Email addressesof other relevant departments:

Division of TCMStandards: zy@chp.org.cn

Division ofChemical Drug Standards: hy@chp.org.cn

Division of GeneralAffairs: ywzhc@chp.org.cn

Division of DrugInformation: ypxx@chp.org.cn

Division ofPersonnel: rshc@chp.org.cn
Administrative Office:
bgsh@chp.org.cn

Office ofBiological Product Standards: shbb@chp.org.cn

Policies andregulations

DrugAdministration Law of the People’s Republic of China

StandardizationLaw of the People’s Republic of China

Regulations forImplementation of Drug Administration Law of the People’s Republic of China

Charter of the10th Pharmacopoeia Commission

DrugRegistration Regulation