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Overview of Chinese Pharmacopoeia Commission (Chpc) & Update of Chinese Pharmacopoeia (Chp)

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Overview of Chinese Pharmacopoeia Commission (Chpc) & Update of Chinese Pharmacopoeia (Chp) 18/10/2016 Overview of Chinese Pharmacopoeia Commission (ChPC) & Update of Chinese Pharmacopoeia (ChP) Chinese Pharmacopoeia Commission Zhang Wei The Chinese and the European Pharmacopoeias Seminar October 17, 2016 Strasbourg, France Contest 1. Overview of Chinese Pharmacopoeia Commission 2. The Update of Compiling Chinese Pharmacopoeia 3. Main Publications and Websites of Chinese Pharmacopoeia 4. Review and Prospect of International Cooperation & Sino-European Cooperation on Pharmacopoeias 1 18/10/2016 Overview of ChPC Founded by the Ministry of Health in 1950, ChPC is one of the earliest founded organizations for standardization. ChPC invited well-known medical and pharmaceutical experts to be committee members and general election holds every 5 years, up to now, we have formed the pharmacopoeia committee of the tenth. The 11th Pharmacopoeia Commission will be organized by the end of 2016. 3 Overview of ChPC The first Session, 44 members, 1950 The 6th Session, 168 members, 1991 The 10th Session, 350 members, 2010 4 2 18/10/2016 Overview of ChPC: Previous Chairmen Chairmen is generally taken by the head of Ministry of Health or Food and Drug Administration as part-time duty. Li Dequan Tang Tenghan Qian Xinzhong The first and second The third session The fourth session sessions Cui Yueli Chen Minzhang Shao Mingli Chen Zhu The fifth session The 6th and 7th The 8th and 9th The 10th session session session 5 Overview of ChPC: Organization Structure The 10th Session of Pharmacopeia Commission Permanent Establishment Chinese Pharmacopeia Honorary Chairman Commission Sang Guowei vice-chairman of the Bureau-level Executive Committee 11th NPC Standing Committee Public Units 29 academicians of the Chairman Secretary general Chinese Academy of Sciences Chen Zhu former Minister of responsibility system and Chinese Academy of Engineering Ministry of Health， vice-chairman of the Directors of specialized committee th Representatives of related 12 NPC Standing Committee administrative department Executive Vice-chairman Shao Mingli former Director of SFDA Vice-Chairman Yu Wenming Vice-director of Administration of Traditional Chinese Medicine 23 Expert Committees Chen Xinnian former Vice-director of 350 Pharmacopoeia Commission members Health Department General Logistics 26 Advisory Commission members Department of PLA Wu Zhen former Vice Minister of SFDA Deputy Director of CFDA 6 3 18/10/2016 Overview of ChPC: 23 Specialized Committee Traditional Chinese Biological Products Medical Specialties Medicine Science Chemical Products Chinese Materia medica Western & prepared slices of Biotechnology Chemical Products I Antibiotics medical science Chinese crude drugs Chinese Traditional Chinese Virus product Patent Medicines Chemical Products II Biochemical Products medical science Natural Medicine Chemical Products III Radiopharmaceutical Bacterium Products Ethno- Medicine Blood Products Appendices Method & interdisciplinary Physical Preparations Microbiology & Chemical Analysis Name and Terminology Pharmaceutical Bioassay Excipient Reference Material & Container 7 Overview of ChPC: Permanent Establishment Permanent Establishment： Division of General Affairs Institutions Directly under the CFDA， Secretary general Division of Traditional Chinese responsibility system ， Medicine Standards Personnel 50 people . Division of Chemical Drug Standards Chinese Division of Biological Product Standards Pharmacopeia Commission Secretary General Division of Medical Evaluation Deputy Secretary General Administrative Office Division of Personnel Division of Communication and Exchange Division of Quality Management (Research Office) 4 18/10/2016 Overview of ChPC: Main Responsibility of Permanent Establishment Organize the drafting and revision of ChP and its addendums. Organize the drafting and revision of national drug standards and quality standards for pharmaceutical excipients, packaging materials in direct contact with drug substances, as well as containers. Participate in the evaluation of the implementation performance of the ChP and national drug standards. Be responsible for the communication, training and technical consultation of the ChP and national drug standards. Participate in the drafting of management systems for the standards of medications, pharmaceutical excipients, packaging materials in direct contact with drug substances, as well as containers, and establish and improve drug standard management system and relevant working mechanisms. Organize the conduct of research and drug standardization strategies, drug standard management policies and technical regulations, and undertake the analysis and evaluation tasks of pharmaceutical and medical clinical information. Overview of ChPC: Main Responsibility of Permanent Establishment Carry out international communication and cooperation related to drug standards, and participate in the international drug standard Certificate of Suitability cooperation and the drafting and revision of international drug standards. Be responsible for the drug standard information construction. Be responsible for organizing the editing, publishing and distribution of publications and journals including the ChP series and Drug Standards of China. Be responsible for the organization, coordination and service assurance for relevent conference in accordance with the Charter of the Pharmacopoeia Commission. Undertake other tasks assigned by the CFDA. 5 6 18/10/2016 Department of Medical Device Bureau of Retired Supervision Personnel Department of Drug and Cosmetics Department of Supervision International Cooperation Department of Medical Device Registration eration eration Department of Planning and Department of Drug and Finance Cosmetics Registration Department III of food Department of safety supervision Human Resource ites of Chinese Pharmacopoeia of ites Department II of food safety supervision Department of Information Minister of CFDA Contest Department I of food safety supervision Department of Science Technology and Standard Department of Law and Regulation Vice Ministers of CFDA Ministers Vice Department of Department of general Emergency administration (Policy planning office) Internal Structure of CFDA of Structure Internal & Sino-European Cooperation on Pharmacopoeias Cooperation & Sino-European Bureau of Inspection General Office Commission 1. Overview of Chinese Pharmacopoeia of Compiling Chinese Pharmacopoeia 2. The Update and Webs 3. Main Publications Coop of International and Prospect 4. Review 18/10/2016 1. Historical Development of ChP By far, Editions of 1953, 1963, 1977, 1985, 1990, 1995, 2000, 2005, 2010 and 2015 were issued, totally ten editions. Since 1985, new edition of ChP was issued every 5 years. (Complementary version was published during the intervals.) The latest ChP 2015 was issued on June 5, 2015 and officially complemented on December 1st of 2016, including four Volumes, respectively Traditional Chinese Medicine, Chemical Medicine, Biological Products, General Requirement and Pharmaceutical Excipients. 2. Goal and Principle of Compiling ChP Goal： Ensure drug safety, effectiveness & quality control Principle： Scientific, advanced, normative & practical 7 18/10/2016 Procedure of Compiling Chinese Pharmacopoeia Companies, social groups, professional parties and experts as well as individuals submit opinions and suggestions & initiative modification by ChP 1 Hold Committee conference to review the outline of compiling Pharmacopoeia 2 Conducts selection of monograph, arrange draft and review of the standards 3 The Specialized Committees determine tasks of revising standards Institute for drug control, universities and scientific research academies are responsible for 4 carrying out test & study, drafting standards and technical review 5 The related Specialized Committees conduct technical reviews Publish the draft standards online and collect comments from industry 6 (company conduct researches on the applicability of standards) 7 The Executive Committee examines and approves the draft Pharmacopoeia 8 Reviewed, approved by CFDA, then issued implemented Introduction of Chinese Pharmacopoeia 2015 Chinese Pharmacopoeia 2015 Edition Traditional Chinese Medicine Chemical medicines, Biological Products General Requirements for materials and decoction pieces antibiotics Include vaccine, serum, preparation Vegetable fat and extract Biochemical biotechnological products, Testing Methods Preparations and single herb blood products and diagnostic Radiopharmaceuticals Guidance preparation reagent etc. Pharmaceutical Excipients 8 18/10/2016 Newly Add, Revision of Chinese Pharmacopoeia 2015 CP 2015 Monographs Category in CP 2010 Monographs Newly Added Revised Non-collected to be Collected Monographs Monographs Monographs Traditional Chinese 2165 2598 440 517 7 Medicine Chemical Medicines 2139 2603 492 415 28 Pharmaceutical 132 270 137 97 2 Excipients Monographs 131 137 13 105 6 Biological General Products 10 108 10 21 / Requirement Total 4567 5608 1082 1134 43 General Requirement / 316 43 67 / (appendix) Characteristics of CP 2015 (1) —Increased Monographs 5,608 monographs collected in total, with 23.7% growth Chinese Pharmacopoeia 2010 Increased Monographs in Chinese Pharmacopoeia 2015 National Drug Standards (included in the issuing of the bureau) About 2,800 monographs with improved standards 9 18/10/2016 Variation Trend of Monographs Collected in Chinese Pharmacopoeia Number of Monographs Collected in Chinese Pharmacopoeia Comparison of Collected Chemical Medicines with other Pharmacopoeia
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