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of the State Council in the Opinions on Deepening the Review & Approval System Reform and Encouraging the Drug and Medical Device Innovation (SC & CPC Central Committee [2017] No.

1 2018. Volume 1 CHINA FOOD AND DRUG NEWSLETTER 中国食品药品国际交流中心施维雅 ( 天津 ) 制药有限公司 CFDA Released the Announcement on the Catalogue of China's Marketed Drugs 国家食品药品监管总局发布中国上市药品目录集的公告 On December 29, 2017, CFDA released the Announcement on the Catalogue of China's Marketed Drugs ( Catalogue ) as follows: As per the requirements of the General Office of the CPC Central Committee and the General Office of the State Council in the Opinions on Deepening the Review & Approval System Reform and Encouraging the Drug and Medical Device Innovation (SC & CPC Central Committee [2017] No. 42), to safeguard the rights and interests of the public drug use, improve the quality of medicines, reduce the medication burden, and encourage the drug R&D and innovation, CFDA organized the formulation of the Catalogue and the relevant issues are announced as follows: I. As the carrier of CFDA for releasing information of drugs approved for marketing, the Catalogue records the specific information of such drugs approved for marketing as innovative drugs, modified new drugs, generic drugs subject to new registration classification of chemical drugs, and drugs accredited by consistency evaluation of the quality and efficacy. The reference preparations and standard preparations of generic drugs are designated, and the specific varieties of generic drugs that can replace the originators are labeled to facilitate the understanding and inquiry by the pharmaceutical industry, the medical community and the public. II. The Catalogue publishes the drug review reports, package inserts, patent information and links to other databases via CFDA's government website. III. The current Catalogue contains 131 varieties and 203 strengths, including 13 varieties and 17 strengths of drugs accredited by consistency evaluation of the quality and efficacy of generic drugs. CFDA will incorporate into the Catalogue with real-time updates the drugs subject to new registration classification and drugs accredited by consistency evaluation of the quality and efficacy of generic drugs, and other drugs newly approved for marketing. (December 29, 2017) 2017 年 12 月 29 日, 国家食品药品监督管理总局发布中国上市药品目录集的公告, 内容如下 : 根据中共中央办公厅国务院办公厅关于深化审评审批制度改革鼓励药品医疗器械创新的意见 ( 厅字号 ) 要求, 为维护公众用药权益, 提高药品质量, 降低用药负担, 鼓励药物研发创新, 国家食品药品监督管理总局组织制定了中国上市药品目录集, 现将有关事宜公告如下 : 一中国上市药品目录集是国家食品药品监督管理总局发布批准上市药品信息的载体, 收录批准上市的创新药改良型新药化学药品新注册分类的仿制药以及通过质量和疗效一致性评价药品的具体信息指定仿制药的参比制剂和标准制剂, 标示可以替代原研药品的具体仿制药品种等, 供制药行业和医学界人员及社会公众了解和查询二中国上市药品目录集在国家食品药品监督管理总局政府网站以网络版形式发布并链接药品审评报告说明书专利信息等数据库三现发布的中国上市药品目录集收录了 131 个品种,203 个品种规格, 其中包括通过仿制药质量和疗效一致性评价的 13 个品种,17 个品种规格国家食品药品监督管理总局将对新批准上市的新注册分类药品以及通过仿制药质量和疗效一致性评价的药品直接纳入中国上市药品目录集, 实时更新 ( ) CFDA Issued the Provisions for the Disclosure of Food and Drug Safety Supervision Information 国家食品药品监督管理总局印发食品药品安全监管信息公开管理办法 To enhance the publicity of regulatory information on food and drug safety, protect the public's right to information, participation, expression and supervision, promote the social co-governance of food and drug safety, and enable "Government in the Sunshine", CFDA formulated the Provisions for the Disclosure of Food and Drug Safety Supervision Information which was issued on December 22, (December 22, 2017) 为加强食品药品安全监管信息公开, 保障公众的知情权参与权表达权和监督权, 推进食品药品安全社会共治, 打造阳光政府部门, 国家食品药品监督管理总局制定了食品药品安全监管信息公开管理办法, 于 2017 年 12 月 22 日发布 ( ) Published by China Center for Food and Drug International Exchange Servier (Tianjin) Pharmaceutical Co., Ltd.

2 CFDA Announcement on Promulgating the Guidelines for the Development of Drug Supplementary Testing Methods To regulate and guide the development of drug supplementary testing methods, and strengthen the supportive role of testing technologies in drug supervision and administration, on January 9, 2018, CFDA promulgated the Guidelines for the Development of Drug Supplementary Testing Methods in accordance with the regulatory needs. (January 9, 2018) 国家食品药品监督管理总局发布药品补充检验方法研制指南为规范和指导药品补充检验方法研制工作, 强化检验检测技术对药品监管的支撑作用, 根据监管工作需要,2018 年 1 月 9 日, 国家食品药品监督管理总局发布药品补充检验方法研制指南 ( ) CFDA Modified the Package Inserts of 32 OTCs Encompassing DieDa WanHua Oil According to the results of monitoring and evaluation, to further ensure the safety of public use of drugs, CFDA decided to modify the package inserts of 32 OTCs encompassing DieDa WanHua Oil, and has made a public announcement on the relevant matters on January 9, (January 9, 2018) 国家食品药品监督管理总局修订跌打万花油等 32 种非处方药说明书根据监测评价结果, 为进一步保障公众用药安全, 国家食品药品监督管理总局决定对跌打万花油等 32 种非处方药说明书进行修订 2018 年 1 月 9 日, 就修订有关事项发布了公告 ( ) CFDA Issued the Guidelines for Clinical Trials of OAB Drugs To guide and regulate the clinical trials of overactive bladder (OAB) drugs, CFDA organized to formulate the Guidelines for Clinical Trials of OAB Drugs which was issued on January 3, (January 3, 2018) 国家食品药品监督管理总局发布膀胱过度活动症药物临床试验指导原则为指导和规范膀胱过度活动症药物临床试验, 国家食品药品监督管理总局组织制定了膀胱过度活动症药物临床试验指导原则, 于 2018 年 1 月 3 日发布 ( ) CFDA Issued the Announcement on Attribute Definition Results of the Fourth Batch of Drug-Device Combination Products To guide the applicants for rational applications, on January 2, 2018, CFDA issued the Attribute Definition Results of the Fourth Batch of Drug-Device Combination Products. Annex: Summary of Attribute Definition Results of the Fourth Batch of Drug-Device Combination Products (omitted) (January 2, 2018) 国家食品药品监督管理总局发布第四批药械组合产品属性界定结果的公告为引导申请人合理申报,2018 年 1 月 2 日, 国家食品药品监督管理总局发布第四批药械组合产品属性界定结果附件 : 第四批药械组合产品属性界定结果汇总 ( 略 ) ( ) 2 CHINA FOOD AND DRUG NEWSLETTER

CFDA Released the Provisions for the Lot Release of Biological Products 国家食品药品监督管理总局发布生物制品批签发管理办法 On December 29, 2017, CFDA released the revised Provisions for the Lot Release of Biological

(December 29, 2017) 2017 年 12 月 29 日, 国家食品药品监督管理总局发布修订后的生物制品批签发管理办法 ( 国家食品药品监督管理总局令第 39 号 ), 强化生物制品批签发管理工作办法自 2018 年 2 月 1 日起施行 (2017-12-29) CFDA Issued the List of Reference Preparations of

3 CFDA Released the Provisions for the Lot Release of Biological Products 国家食品药品监督管理总局发布生物制品批签发管理办法 On December 29, 2017, CFDA released the revised Provisions for the Lot Release of Biological Products (CFDA Order No. 39) to strengthen the management in the lot release of biological products. The Provisions shall come into force as from February 1, (December 29, 2017) 2017 年 12 月 29 日, 国家食品药品监督管理总局发布修订后的生物制品批签发管理办法 ( 国家食品药品监督管理总局令第 39 号 ), 强化生物制品批签发管理工作办法自 2018 年 2 月 1 日起施行 ( ) CFDA Issued the List of Reference Preparations of Generic Drugs (Eleventh Batch) On December 29, 2017, CFDA issued the List of Reference Preparations of Generic Drugs (Eleventh Batch), which has been reviewed and determined by the Committee of Experts on Consistency Evaluation of the Quality and Efficacy of Generic Drugs. (December 29, 2017) 国家食品药品监督管理总局发布仿制药参比制剂目录 ( 第十一批 ) 经国家食品药品监督管理总局仿制药质量和疗效一致性评价专家委员会审核确定,2017 年 12 月 29 日, 仿制药参比制剂目录 ( 第十一批 ) 发布 ( ) NHFPC & CFDA Issued the Management Practice for the Storage and Transportation of Vaccines (2017 Edition) To strengthen the management of vaccine storage and transportation, according to the revised Regulations for Vaccine Distribution and Vaccination and the Opinions on Further Strengthening the Management of Vaccine Distribution and Vaccination (SC [2017] No. 5), NHFPC and CFDA have amended the Management Practice for the Storage and Transportation of Vaccines (Bureau of Disease Prevention and Control, NHFPC [2006] No. 104), and formed the 2017 Edition thereof which was issued on December 28, (December 28, 2017) 国家卫生计生委食品药品监管总局印发疫苗储存和运输管理规范 (2017 年版 ) 为加强疫苗储存和运输管理工作, 根据修订后的疫苗流通和预防接种管理条例和关于进一步加强疫苗流通和预防接种管理工作的意见 ( 国办发号 ), 国家卫生计生委食品药品监管总局对疫苗储存和运输管理规范 ( 卫疾控发号 ) 进行了修订, 形成了疫苗储存和运输管理规范 (2017 年版 ), 于 2017 年 12 月 28 日印发 ( ) CFDA Released the Opinions on Encouraging Pharmaceutical Innovation via Priority Review & Approval On December 28, 2017, CFDA released the Opinions on Encouraging Pharmaceutical Innovation via Priority Review & Approval, which clarified the scope, procedures of and requirements for the priority review & approval and shall be effective since the date of promulgation. (December 28, 2017) 国家食品药品监督管理总局发布关于鼓励药品创新实行优先审评审批的意见 2017 年 12 月 28 日, 国家食品药品监督管理总局发布关于鼓励药品创新实行优先审评审批的意见, 明确了优先审评审批的范围优先审评审批的程序以及优先审评审批工作要求意见自发布之日起实施 ( ) Volume I

4 CFDA Released Five Technical Guidelines for Clinical Study Incl. the Technical Guidelines for Clinical Study of New TCMs for Irritable Bowel Syndrome 国家食品药品监督管理总局发布中药新药用于肠易激综合征临床研究技术指导原则等 5 个临床研究技术指导原则 To encourage and guide the R&D and innovation of new TCMs and accelerate the improvement of technical standards system for review in line with the TCM characteristics, CFDA organized to formulate the Technical Guidelines for Clinical Study of New TCMs for Irritable Bowel Syndromes, the Technical Guidelines for Clinical Study of New TCMs for Functional Dyspepsia, the Technical Guidelines for Clinical Study of New TCMs for Cough Variant Asthma, the Technical Guidelines for Clinical Study of New TCMs for Rheumatoid Arthritis, and the Technical Guidelines for Clinical Study of New TCMs for Chronic Heart Failure, which were issued on December 27, (December 27, 2017) 为鼓励和引导中药新药的研发创新, 加快完善符合中医药特点的审评技术标准体系, 国家食品药品监督管理总局组织制定了中药新药用于肠易激综合征临床研究技术指导原则中药新药用于功能性消化不良临床研究技术指导原则中药新药用于咳嗽变异性哮喘临床研究技术指导原则中药新药用于类风湿关节炎临床研究技术指导原则中药新药用于慢性心力衰竭临床研究技术指导原则, 于 2017 年 12 月 27 日发布 ( ) CFDA Released the Technical Guidelines for Assessment of TCM Resources 国家食品药品监督管理总局发布中药资源评估技术指导原则 To protect, realize the sustainable use of, and guarantee the stable supply of, TCM resources, and ensure the quality controllability of TCMs, CFDA organized to formulate the Technical Guidelines for Assessment of TCM Resources which was issued on December 25, (December 25, 2017) 为保护中药资源, 实现中药资源可持续利用, 保障中药资源的稳定供给和中药产品的质量可控, 国家食品药品监督管理总局组织制定了中药资源评估技术指导原则, 于 2017 年 12 月 25 日发布 ( ) CFDA Released the Technical Guidelines for Expression of Chinese Patent Medicine Strengths 国家食品药品监督管理总局发布中成药规格表述技术指导原则 To strengthen the registration management and standardize the expression of strengths of Chinese patent medicines (CPMs), CFDA organized to formulate the Technical Guidelines for Expression of Chinese Patent Medicine Strengths which was issued on December 25, The expression of CPM strengths shall invariably follow the above Guidelines for new TCMs whose registration applications have been accepted prior to or after the issuance of the said Guidelines, and for post-marketing applications for changes and supplementary applications that are subject to CFDA approval. The standardization of strengths of the marketed CPMs will be gradually implemented via the development and revision work of national standards and post-marketing applications for changes and supplementary applications. (December 25, 2017) 为加强注册管理, 规范中成药规格表述, 食品药品监管总局组织制定了中成药规格表述技术指导原则, 于 2017 年 12 月 25 日发布上述技术指导原则发布前已经受理的及发布后新受理的中药新药属于国家食品药品监督管理总局审批的上市后变更补充申请, 均应根据此技术指导原则的要求规范表述中成药规格对已上市中成药规格的规范, 将通过国家标准的制修订工作及上市后变更补充申请等逐步进行 ( ) 4 CHINA FOOD AND DRUG NEWSLETTER

5 Medical Devices CFDA Released the Technical Guidelines for Accepting Overseas Clinical Trial Data of Medical Devices 医疗器械国家食品药品监督管理总局发布接受医疗器械境外临床试验数据技术指导原则 As per the Opinions on Deepening the Review & Approval System Reform and Encouraging the Drug and Medical Device Innovation (SC & CPC Central Committee [2017] No. 42) issued by the General Office of the CPC Central Committee and the General Office of the State Council, to strengthen the registration management for medical devices, further improve the quality of registration review, and encourage the R&D and innovation of medical devices, CFDA organized to formulate the Technical Guidelines for Accepting Overseas Clinical Trial Data of Medical Devices which was issued on January 11, The Guidelines put forward the ethical principles, legal principles and scientific principles for accepting data from overseas clinical trials and clarified the dossiers requirements and technical requirements for such data. The Guidelines expounded the considerations and technical requirements for accepting overseas clinical trial data in relation to the technical review requirements, the subject population and the differences in clinical trial conditions, and give specific examples for diversified factors' clinical implications on the data. (January 11, 2018) 为贯彻落实中共中央办公厅国务院办公厅关于深化审评审批制度改革鼓励药品医疗器械创新的意见 ( 厅字号 ), 加强医疗器械产品注册工作的管理, 进一步提高注册审查质量, 鼓励医疗器械研发创新, 国家食品药品监督管理总局组织制定了接受医疗器械境外临床试验数据技术指导原则, 于 2018 年 1 月 11 日发布指导原则提出了接受境外临床试验数据的伦理原则依法原则和科学原则, 明确了境外临床试验数据的资料要求和技术要求指导原则从技术审评要求受试人群临床试验条件的差异等方面, 阐述了接受境外临床试验资料时的考虑因素及技术要求, 并给出了不同因素对临床数据产生有临床意义影响的具体实例 ( ) CFDA Released the Guidelines for Design of Medical Device Clinical Trials 国家食品药品监督管理总局发布医疗器械临床试验设计指导原则 As per the Opinions on Deepening the Review & Approval System Reform and Encouraging the Drug and Medical Device Innovation (SC & CPC Central Committee [2017] No. 42) issued by the General Office of the CPC Central Committee and the General Office of the State Council, to strengthen the registration management for medical devices, further improve the quality of registration review, and encourage the R&D and innovation of medical devices, CFDA organized to formulate the Guidelines for Design of Medical Device Clinical Trials which was issued on January 8, (January 8, 2018) 为贯彻落实中共中央办公厅国务院办公厅关于深化审评审批制度改革鼓励药品医疗器械创新的意见 ( 厅字号 ), 加强医疗器械产品注册工作的管理, 进一步提高注册审查质量, 鼓励医疗器械研发创新, 国家食品药品监督管理总局组织制定了医疗器械临床试验设计指导原则, 于 2018 年 1 月 8 日发布 ( ) CFDA General Office Released the Notice on Conducting Medical Device Testing As per the Opinions on Deepening the Review & Approval System Reform and Encouraging the Drug and Medical Device Innovation (SC & CPC Central Committee [2017] No. 42) issued by the General Office of the CPC Central Committee and the General Office of the State Council, and the Opinions of the State Council on the Reform of the Review & Approval System for Drugs and Medical Devices (SC [2015] No. 44), to effectively give play to the technical support of medical device testing agencies and ensure orderly registration of medical devices, on January 3, 2018, the General Office of CFDA released the Notice on Conducting Medical Device Testing, requiring the food and drug administrations of all provinces, autonomous regions and municipalities directly under the central government to further strengthen the supervision 国家食品药品监督管理总局办公厅发布关于做好医疗器械检验有关工作的通知为贯彻落实中共中央办公厅国务院办公厅关于深化审评审批制度改革鼓励药品医疗器械创新的意见 ( 厅字号 ) 和国务院关于改革药品医疗器械审评审批制度的意见 ( 国发号 ), 切实发挥好医疗器械检验机构技术支撑力量, 保证医疗器械注册工作秩序,2018 年 1 月 3 日, 国家食品药品监督管理总局办公厅发布关于做好医疗器械检验有关工作的通知, 要求各省自治区直辖市食品药品监督管理局要进一步加强对所属医疗器械检验机构的 Volume I

and management and perform effective guidance and coordination of their affiliated medical device testing agencies, which shall perform testing over the tobe-registered products commissioned by

6 and management and perform effective guidance and coordination of their affiliated medical device testing agencies, which shall perform testing over the tobe-registered products commissioned by medical device applicants based on product technical specifications, and issue the testing reports for product registration. (January 3, 2018) 监督管理, 做好指导协调, 各医疗器械检验机构要对医疗器械注册申请人委托检验的注册产品依据产品技术要求进行检验, 并出具检验报告用于产品注册 ( ) CFDA Issued the Announcement on Adjusting the Attributes and Classification of Allergen IVD Reagents, Supportive IVD Reagents for Flow Cytometer, and Immunohistochemistry and In Situ Hybridization IVD Reagents 国家食品药品监督管理总局发布关于过敏原类流式细胞仪配套用免疫组化和原位杂交类体外诊断试剂产品属性及类别调整的通告 As per the Opinions of the State Council on the Reform of the Review & Approval System for Drugs and Medical Devices (SC [2015] No. 44) and the Opinions on Deepening the Review & Approval System Reform and Encouraging the Drug and Medical Device Innovation (SC & CPC Central Committee [2017] No. 42) issued by the General Office of the CPC Central Committee and the General Office of the State Council,, to further improve the classification management of IVD reagents, determine and divide the attributes and categories of some IVD reagents in an scientific and reasonable manner, CFDA organized the study and adjusted the attribute definition and classification principles of allergen IVD reagents, supportive IVD reagents for flow cytometer, and immunohistochemistry and in situ hybridization IVD reagents, formulated the product classification list, and clarified the implementation requirements according to the Regulations for the Supervision and Administration of Medical Devices, the Provisions for In-vitro Diagnostic Reagent Registration and other relevant provisions, as well as the status of medical device production, distribution, use and risk analysis, the comprehensive opinions of medical device manufacturers, distributors, user units and trade organizations, and the practice of international classification of medical devices. The Announcement shall come into force as from March 1, (December 29, 2017) 为贯彻落实国务院关于改革药品医疗器械审评审批制度的意见 ( 国发号 ) 和中共中央办公厅国务院办公厅印发的关于深化审评审批制度改革鼓励药品医疗器械创新的意见 ( 厅字号 ), 进一步做好体外诊断试剂分类管理工作, 科学合理确定和划分部分体外诊断试剂属性和类别, 根据医疗器械监督管理条例体外诊断试剂注册管理办法等有关规定, 国家食品药品监督管理总局根据医疗器械生产经营使用情况和风险分析, 充分听取医疗器械生产经营企业以及使用单位行业组织的意见, 参考国际医疗器械分类实践, 组织研究调整了过敏原类流式细胞仪配套用免疫组化和原位杂交类体外诊断试剂的属性界定和分类原则, 制定了产品分类列表并明确了有关实施要求通告自 2018 年 3 月 1 日起实施 ( ) CFDA Released the Guidelines for Technical Review of Mobile Medical Device Registration On December 29, 2017, CFDA released the first Guidelines for Technical Review of Mobile Medical Device Registration (hereinafter referred to as the Guidelines) for mobile medical devices. The Guidelines apply to devices and/or software that use noninvasive "mobile computing terminals" for one or more medical purposes. The definitions, types, judgment principle and general requirements for registration application dossiers of mobile medical devices are further clarified. According to the Guidelines, mobile medical devices, as a combination of mobile computing technology and traditional medical devices, shall take into account the characteristics, risks and control measures of mobile computing technologies in addition to the requirements of traditional medical devices, including cybersecurity capability, display screen limit, ambient light image, battery capacity limit, cloud computing service and so forth. (December 29, 2017) 国家食品药品监督管理总局发布移动医疗器械注册技术审查指导原则 2017 年 12 月 29 日, 国家食品药品监管总局发布了首个关于移动医疗器械的移动医疗器械注册技术审查指导原则 ( 以下简称指导原则 ) 指导原则适用于采用无创移动计算终端实现一项或多项医疗用途的设备和 / 或软件明确了移动医疗器械的定义类型判定原则和注册申报资料总体要求根据指导原则要求, 移动医疗器械作为移动计算技术与传统医疗器械的结合, 除考虑传统医疗器械的要求之外还需综合考虑移动计算技术的特点风险及其控制措施, 包括网络安全能力显示屏限制环境光影像电池容量限制云计算服务等 ( ) 6 CHINA FOOD AND DRUG NEWSLETTER

CFDA Released the Management Practice for the Development and Revision of Medical Device Standards As per the Opinions on Deepening the Review & Approval System Reform and Encouraging the Drug and

7 CFDA Released the Management Practice for the Development and Revision of Medical Device Standards As per the Opinions on Deepening the Review & Approval System Reform and Encouraging the Drug and Medical Device Innovation (SC & CPC Central Committee [2017] No. 42) issued by the General Office of the CPC Central Committee and the General Office of the State Council, and the Provisions for Medical Device Standards (CFDA Order No. 33), CFDA organized to revise the Management Practice for the Development and Revision of Medical Device Standards which was issued on December 25, (December 25, 2017) 国家食品药品监督管理总局发布医疗器械标准制修订工作管理规范为贯彻落实中共中央办公厅国务院办公厅关于深化审评审批制度改革鼓励药品医疗器械创新的意见 ( 厅字号 ), 根据医疗器械标准管理办法 ( 国家食品药品监督管理总局令第 33 号 ) 有关规定, 国家食品药品监督管理总局组织修订了医疗器械标准制修订工作管理规范, 于 2017 年 12 月 25 日发布 ( ) CFDA Released the Provisions for the Supervision and Administration of Online Sales of Medical Devices 国家食品药品监督管理总局发布医疗器械网络销售监督管理办法 On December 22, 2017, CFDA promulgated the Provisions for the Supervision and Administration of Online Sales of Medical Devices (CFDA Order No. 38), which shall come into force on March 1, (December 22, 2017) 2017 年 12 月 22 日, 国家食品药品监督管理总局发布医疗器械网络销售监督管理办法 ( 国家食品药品监督管理总局令第 38 号 ), 办法自 2018 年 3 月 1 日起施行 ( ) Special Column Comprehensively Improve the Quality and Efficacy of Generic Drugs: the First Batch of 17 Strengths Passed the Consistency Evaluation The high-profile consistency evaluation of the quality and efficacy of generic drugs reaped phased achievements in the pharmaceutical industry - CFDA recently released the list of the first batch of 17 strengths that passed the consistency evaluation of the quality and efficacy of generic drugs. This marks another step forward in the process of comprehensively improving the quality and efficacy of generic drugs in China. In recent years, CFDA has stepped up the pace of the drug review & approval system reform and gradually solved the resource constraints of clinical trial institutions for bioequivalence (BE) trials and difficult access to reference preparations. The selection of reference preparations was conducted smoothly and the human BE study of some drug varieties was exempted. The review, verification, testing and other work have been consolidated to accelerate the consistency evaluation. As of January 2, 2018, a total of 309 records of BE test for consistency evaluation were filed, covering 182 records for 73 varieties (in the Essential Drug List) from 124 enterprises, and 127 records for 77 varieties (not covered by the Essential Drug List) from 84 enterprises. A total of 6,028 records for reference preparations were filed, covering 3,141 varieties in the Essential Drug List and 695 record-filing enterprises. Of the 13 varieties (17 strengths) that have passed the consistency evaluation, there are 4 varieties (4 strengths) out of 289-Essential Drug List and 9 varieties (13 strengths) not covered by the 289-Essential Drug List. (January 4, 2018) 专栏全面提升仿制药质量和疗效首批 17 个品规通过一致性评价备受医药行业瞩目的仿制药质量和疗效一致性评价工作取得阶段性成果国家食品药品监管总局日前发布首批 17 个通过仿制药质量和疗效一致性评价品种规格的目录这标志着我国全面提升仿制药质量和疗效的进程又迈出坚实步伐近年来, 总局加大药品审评审批制度改革步伐, 逐步解决生物等效性试验 (BE) 临床试验机构资源紧张, 参比制剂难获得等难题, 扎实做好参比制剂遴选, 豁免体内 BE 品种研究, 强化审评核查检验等各项工作, 加快推进一致性评价工作截至 2018 年 1 月 2 日, 一致性评价 BE 备案共计 309 条, 属于基药目录内的 182 条, 共计 124 家企业 73 个品种, 目录外的 127 条, 共计 84 家企业 77 个品种 ; 参比制剂备案共计 6028 条, 其中基药目录中品种为 3141 条 ; 备案的企业 695 家目前已通过一致性评价的 13 个品种 (17 个品规 ) 中,289 个基药目录中有 4 个品种 (4 个品规 ), 非 289 个基药目录中有 9 个品种 (13 个品规 ) ( ) Volume I

8 Notes: All Chinese information in the Newsletter is extracted from newspapers and the Internet. All English articles are translations from the Chinese version. For electronic version of the Newsletter please visit 备注 : Newsletter 中所有中文信息摘自报刊及网络英文均系中文翻译电子版 Newsletter 阅览请登录网站 China Center for Food and Drug International Exchange (CCFDIE) 中国食品药品国际交流中心 Address: Room 1106, 11th Floor, Office Building B, Maples International Center, No. 32, Xizhimen North Street, Haidian District, Beijing, , P.R.C. 中国北京市海淀区西直门北大街 32 号枫蓝国际中心 B 座写字楼 11 层 1106 室邮编 : Tel: Fax: ccfdie@ccfdie.org Website: Servier (Tianjin) Pharmaceutical Co., Ltd. 施维雅 ( 天津 ) 制药有限公司 Address: 6 Floor, West Building, World Financial Center, No.1, East 3rd Ring Middle Road, Chaoyang District, Beijing, China 北京市朝阳区东三环中路 1 号环球金融中心西楼 6 层邮政编码 : Tel: Fax: Website: 8 CHINA FOOD AND DRUG NEWSLETTER

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CIP 2010 上海商务发展政策汇编上海市商务委员会上海科学技术文献出版社 CIP 前言 2010 上海商务发展政策汇编由上海市商务委员会汇集整理, 收录了近年来上海市政府及其相关职能部门出台的有关商务领域的产业发展产业管理扩大