Main contents Overview of Chinese Pharmacopoeia - Overview of the - PDF document

19/09/2018 CHINESE PHARMACOPOEIA AND PROGRESS IN THE COMPILATION OF CHINESE PHARMACOPOEIA 2020 Chinese Pharmacopoeia Commission Zhang Wei, Secretary General ChP-EDQM Workshop on Pharmaceutical Excipients 18 September, 2018, Strasbourg, France Main contents  Overview of Chinese Pharmacopoeia - Overview of the Pharmacopoeia Commission - Overview of the Chinese Pharmacopoeia Commission  ChP developing plan  Progress in the new edition of ChP  ChP-EDQM Cooperation 1

19/09/2018 The Status and Role of the Chinese Pharmacopoeia The national drug standard is the technical regulation made by the state to ensure the quality of drugs, the quality specifications, testing methods and manufacturing processes of drugs. It must be abided by in all aspects of drug research, production, operation, use and supervision and management. It is a set of compulsory technical guidelines and statutory basis. The "Chinese Pharmacopoeia" is  The Drug Administration Law of the promulgated by the State Drug People's Republic of China explicitly Administration and is a drug code established by the state to ensure the stipulates that “drug production quality of drugs, to ensure access to must comply with national drug safe, effective and quality controllable standards. The Pharmacopoeia of drugs for the people. The Chinese Pharmacopoeia plays an important the People's Republic of China and role in ensuring the quality of the drug standards promulgated by medicines, safeguarding and protecting the public health and the drug regulatory authority legitimate rights of the people to use under the State Council are medicines. It also plays an important national drug standards”. role in promoting the healthy development of China's pharmaceutical industry. Overview of ChP Committees  In 1950, the Ministry of Health established the Pharmacopoeia Committee, including a Secretariat (standing organization) and a team of experts, and began to organize the preparation of pharmacopoeia. It was the earliest established standardization body. So far, the 11th Pharmacopoeia Committee has been established and the preparation of  the 10th edition of the Chinese Pharmacopoeia has been completed.  It is jointly established by the Ministry of Health, the State (Food and Drug Administration), the State TCM Administration, and the Ministry of Health.  A well-known Chinese and Western medicine experts are recruited as members of the committee, with each term lasting for five years One director member and several deputy director members.  4 4 2

19/09/2018 Director members of previous terms Director members are usually Minister of Health or Head of the Drug Authority at the time Li Dequan Qian Xinzhong Tang Tenghan First, second Third Fourth Chen Zhu Bi Jingquan Cui Yueli Chen Minzhang Shao Mingli tenth eleventh Fifth Sixth, seventh ninth 5 5 Group photo of all members in the course of history The first commission, 44 people, 1950 The sixth commission, 168 people, 1991 The tenth commission, 350people, 2010 6 6 6 The eleventh commission, 405 people, 2017 3

19/09/2018 Number of committee members over the years Chart Title 405 450 322 348 400 312 350 300 250 204 168 200 150 112 150 117 91 84 100 50 0 第一届 第二届 第三届 第四届 第五届 第六届 第七届 第八届 第九届 第十届 第十一届 Composition of the 11 th ChP Commission Director Member Director Member Executive Deputy Director Member Deputy Director Member Deputy Director Member Academicians: Zhang Boli, Chen Academicians: Zhang Boli, Chen Academician member:16 Academician member:16   Kaixian, Cao Xuetao Kaixian, Cao Xuetao Expert Committee Expert Committee   Member:26人（part-time） Member:26人（part-time） Organizational member:15 Organizational member:15   Senior expert:6 Senior expert:6   Executive Committee:67 Executive Committee:67 Manament expert: 4 Manament expert: 4   Advisory Advisory Observers:12 from memner:18 memner:18 social groups (11academicians） (11academicians） 340 people of 26 expert 340 people of 26 expert 8 committees committees 4

19/09/2018 Organizational Structure of 11th Pharmacopoeia Commission  26 Expert Committees, 340 members Traditional Chinese Traditional Chinese Chemical Product Chemical Product Biological Product Biological Product Medicine(97 members) Medicine(97 members) (65 members) (65 members) (42 members) (42 members) • Expert Committee of Chemical Products I • • Expert Committee of Ethno- Medicine (16) Expert Committee of Ethno- Medicine (16) (13) • • Expert Committee of Chinese Materia medica Expert Committee of Chinese Materia medica • Expert Committee of Chemical Products II • Expert Committee of Biotechnology and prepared slices of Chinese crude drugs I(16) and prepared slices of Chinese crude drugs I(16) (13) (13) • • Expert Committee of Chinese Materia medica Expert Committee of Chinese Materia medica • Expert Committee of Chemical Products III and prepared slices of Chinese crude drugs II(16) and prepared slices of Chinese crude drugs II(16) • Expert Committee of Vaccine Product (13) • • Expert Committee of Traditional Chinese Patent Expert Committee of Traditional Chinese Patent • Expert Committee of Chemical Products IV (17) Medicines I(15) Medicines I(15) (11) • Expert Committee of Blood Products • Expert Committee of Biochemical Products • • Expert Committee of Traditional Chinese Patent Expert Committee of Traditional Chinese Patent (7) (11) Medicines II(15) Medicines II(15) • Expert Committee of Radiopharmaceutical • • Expert Committee of Natural Medicine(8 ) Expert Committee of Natural Medicine(8 ) (4) preparation, Pharmaceutical Excipient, packaging preparation, Pharmaceutical Excipient, packaging Medical Science(54) Medical Science(54) Material Material • • Expert Committee of Expert Committee of Expert Committee of Physical & Chemical Analysis (18), Expert Committee of Expert Committee of Physical & Chemical Analysis (18), Expert Committee of Traditional Chinese Medicine Traditional Chinese Medicine Preparations (17), Expert Committee of Name and Terminology (9), Expert Committee of Preparations (17), Expert Committee of Name and Terminology (9), Expert Committee of Science (31) Science (31) Bioassay (8),Expert Committee of Microbiology (9), Expert Committee of Bioassay (8),Expert Committee of Microbiology (9), Expert Committee of • • Expert Committee of Medical Expert Committee of Medical 9 Pharmaceutical Excipient and Containers(13), Expert Committee of Reference Material Pharmaceutical Excipient and Containers(13), Expert Committee of Reference Material Specialties (23) Specialties (23) (8) (8) Member composition for the 11 th ChP Commission Member breakdown 15 3% 31 （ 9% ） 40 （ 11% ） 146 （ 42% ） 117 （ 33% ） 药检机构 科研机构 医疗机构 生产企业 管理部门 Facts and figures 5

19/09/2018 Work procedure of ChP Compilation 1953 2015 2020 Executive committee review Executive committee review drafting （ professional, （ （ involving major issues of review, implement ） review, implement ） scientific ,economic and social importance ） importance ） Scientific studies Scientific studies （ professional, CSDA issues promulgation review, order implement ） implement ） Pharmacopeia Pharmacopeia products selection implementation implementation （ principle, lists and （ preparation scope. ） scope. ） period ） period ） New ChP New ChP The next ChP The next ChP Commission 11 Commission to be established established formed formed Standing Institution of ChP Commission  A unit directly affiliated to the former CFDA Practice the Secretary General responsibility  Comprehensive Division system Responsible for the formulation and revision of  national drug standards in accordance with the TCM Standards Division provisions of the Drug Administration Law Chemicals Standards Division Biologics Standards Division ChP Commission Medical Information Division General Office Personnel Affairs Division Publicity and Cooperation Division Quality Management Division 12 12 Zhang Wei, Secretary General 6