and cooperate with the holders to perform post-marketing monitoring, evaluation, recall and disposal, and other responsibilities. Provincial (municipa

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1 2016. Volume 9 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 issued the Notice on Effective Piloting of Drug Marketing Authorization Holder System 国家食品药品监管总局发布 关于做好药品上市许可持有人制度试点有关工作的通知 On June 6, 2016, the State Council General Office issued the Notice on the Issuance of Pilot Plan on Drug Marketing Authorization Holder System (GBF [2016] No. 41). To ensure smooth and orderly implementation of the pilot, on July 7, 2016, CFDA issued Notice on Effective Piloting of Drug Marketing Authorization Holder System, which calls for food and drug regulatory authorities of all provinces, autonomous regions, and municipalities directly under the central government to do the following. I. Earnestly implement the requirements of Pilot Plan on Drug Marketing Authorization Holder System (hereinafter referred to as Pilot Plan), and encourage eligible applicants to apply for participation in the pilot. The qualification of applicants and the range of applied varieties should meet relevant provisions of the Pilot Plan. II. When applying for drug clinical trials or drug marketing, the applicants for pilots can follow the procedures specified in the Provisions for Drug Registration, fill out holder information in the Application Form for Drug Registration and apply to local provincial drug regulatory authorities; the applicants for pilots can also submit a supplementary application in accordance with Paragraph 18, Annex 4 of Provisions for Drug Registration, fill in holder information in the Supplementary Application Form and apply to local provincial drug regulatory authorities. After being reviewed by provincial drug regulatory authorities with review comments issued, the Application shall be subject to CFDA review and approval. Where drug manufacturers apply to hold the authorization, they shall submit photocopies of legal registration certificates of the organization (business license etc.), Pharmaceutical Manufacturing Enterprise License, records of alterations and other supporting documents. III. For commissioned production of drugs, the applicant shall, along with the submission of holder information in application for marketing registration or subsequent supplementary application, submit a written explanation on production from the entrusted manufacturing enterprises, the written contract signed by the applicant and the entrusted enterprise, and the corresponding technical information. The entrusted enterprise should be located within the administrative area of the pilot. IV. The holders of drug marketing authorization are required to fulfill the main responsibility as per the laws and regulations, including the Good Clinical Practice (GCP) in drug R&D, GMP, GSP and post-marketing quality monitoring and evaluation, adverse reaction monitoring, post-marketing studies, risk-benefit assessment and other responsibilities; they shall be responsible for urging entrusted manufacturing enterprises to organize production in strict accordance with relevant requirements of GMP, 2016 年 6 月 6 日, 国务院办公厅发布了 关于印发药品上市许可持有人制度试点方案的通知 ( 国办发 号 ) 为确保试点工作稳妥有序开展,2016 年 7 月 7 日, 国家食品药品监管总局发布 关于做好药品上市许可持有人制度试点有关工作的通知, 要求各省 自治区 直辖市食品药品监督管理局做好以下工作 一 认真落实 药品上市许可持有人制度试点方案 ( 以下简称 试点方案 ) 各项要求, 鼓励符合条件的申请人申报参加试点 申请人条件及申报品种范围需符合 试点方案 的相关规定 二 申请参加试点的申请者, 可以按照 药品注册管理办法 规定的程序, 在申报药物临床试验或者药品上市申请时, 填写 药品注册申请表 中持有人的相关内容, 向其所在地省级药品监督管理部门申报 ; 也可以按照 药品注册管理办法 附件 4 补充申请第 18 项, 提交补充申请, 填写 补充申请表 中持有人的相关内容, 向其所在地省级药品监督管理部门申报 省级药品监督管理部门提出审核意见后, 报食品药品监管总局审批 药品生产企业申请成为持有人的, 应当提交机构合法登记证明文件 ( 营业执照等 ) 药品生产企业许可证 及变更记录页等证明性文件复印件 三 申请人委托生产药品的, 在提交上市注册申请或者之后提交补充申请申报持有人信息时, 应当提交受托生产企业生产的书面说明 申请人与受托生产企业签订的书面合同以及相应的技术资料等 受托生产企业应位于试点行政区域内 四 药品上市许可持有人需履行法律规定的主体责任, 包括药物研发符合 药物临床试验质量管理规范 (GCP) 药品生产质量管理 流通质量管理以及上市后质量监测与评价 不良反应监测 上市后研究 风险获益评估等责任 ; 负责督促受托生产企业严格按照 药品生产质量管理规范 (GMP) 的有关 Published by China Center for Food and Drug International Exchange & Servier (Tianjin) Pharmaceutical Co., Ltd.

2 and cooperate with the holders to perform post-marketing monitoring, evaluation, recall and disposal, and other responsibilities. Provincial (municipal) drug regulatory authorities shall investigate and punish holders and entrusted manufacturing enterprises that violated the laws and regulations such as the Drug Administration Law of the People's Republic of China and relevant provisions of the Pilot Plan, and held accountable those responsible. V. Timely analysis, study and judge should be made to propose suggestions and solutions for the difficulties and problems encountered during the process of pilot, and the proposals shall be submitted to CFDA. During the pilot, periodic assessments should be conducted on a regular basis to analyze and evaluate the acceptance of applications, the approval and postmarketing surveillance of pilot varieties, and the holder's performance of duties, etc., the periodic assessment report shall be reported to CFDA in written form. After the expiration of the pilot, a comprehensive summary of pilot experience should be made, including the overall implementation, the achievements and experiences in each pilot administrative area, and submitted in writing to CFDA. (July 7, 2016) 要求组织生产, 并配合持有人履行上市后的监测 评价及召回 处置等责任 对于违反 中华人民共和国药品管理法 等法律法规和 试点方案 有关规定的持有人及受托生产企业, 持有人所在地省 ( 市 ) 药品监督管理部门应当依法查处, 追究相关责任人的责任 五 试点过程中遇到的困难和问题, 要及时分析研判, 提出解决问题的建议, 一并报送食品药品监管总局 试点工作期间, 应定期开展试点工作的阶段性评估工作, 对申报受理情况 试点品种的批准情况及上市后监管情况 持有人的履职情况等进行分析评估, 将阶段性评估报告书面报送食品药品监管总局 试点期满后, 应及时全面总结试点经验, 将各自试点行政区域内的试点工作整体开展情况以及贯彻落实过程中取得的成绩 经验等, 书面报送食品药品监管总局 ( ) CFDA issued the Announcement on Issues Pertaining to the One-Off Import of Control Drugs for Purpose of R&D 国家食品药品监督管理总局发布 关于研制过程中所需研究用对照药品一次性进口有关事宜的公告 On July 1, 2016, CFDA issued the Announcement on Issues Pertaining to the One-Off Import of Control Drugs for Purpose of R&D ([2016] No. 120), which reads as follows: According to relevant provisions of the Opinions of the State Council on the Reform of the Review & Approval System for Drugs and Medical Devices (GF [2015] No. 44), Notice of the State Council General Office on Carrying out Conformance Evaluation of the Quality and Efficacy of Generic Drugs (GBF [2016] No. 8), Provisions for Drug Registration (SFDA Order [2007] No. 28), Administrative Measures for Import of Drugs (SFDA, GAC Decree [2003] No. 4), and Announcement on Several Policies Pertaining to the Review & Approval of Drug Registration (CFDA Announcement [2015] No. 230), eligible control drugs required in drug R&D can be imported in a one-off manner. The Announcement is made as follows: I. Applicable scope Pharmaceutical R&D institutions or pharmaceutical manufacturing enterprises can apply for one-off import of drugs marketed overseas but has not yet in china during the course of study, for the following purposes: (A) Preparations or APIs used as control drugs in studies for registration of drugs in china. (B) Chemical preparations or APIs used as control drugs in conformance evaluation of the quality and efficacy of generic drugs 年 7 月 1 日, 国家食品药品监督管理总局发布 关于研制过程中所需研究用对照药品一次性进口有关事宜的公告 (2016 年第 120 号 ), 内容如下 : 根据 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 ) 国务院办公厅关于开展仿制药质量和疗效一致性评价意见的通知 ( 国办发 号 ) 药品注册管理办法 ( 国家食品药品监督管理局令 2007 年第 28 号 ) 药品进口管理办法 ( 国家食品药品监督管理局 海关总署令 2003 年第 4 号 ) 及 关于药品注册审评审批若干政策的公告 ( 国家食品药品监督管理总局公告 2015 年第 230 号 ) 的有关规定, 对符合条件的药物研制过程中所需对照药品, 可予以一次性进口 现将有关事项公告如下 : 一 适用范围药品研发机构或药品生产企业在研究过程中, 对已在中国境外上市但境内未上市的药品, 拟用于下列用途的, 可申请一次性进口 : ( 一 ) 以中国境内药品注册为目的的研究中用于对照药品的制剂或原料药 ; ( 二 ) 以仿制药质量和疗效一致性评价 2 CHINA FOOD AND DRUG NEWSLETTER

3 II. Application procedures CFDA shall entrust the provincial food and drug regulatory authorities for handling of the acceptance, review and approval of application for one-off import of control drugs needed in R&D. The specific application procedures are as follows: (A) For applications that comply with the applicable scope and conditions, the applicant shall prepare information as required, fill out the Application Form for Approval for Drug Import (Annex 1), and propose an application for oneoff import of control drug to provincial food and drug regulatory authorities. R&D institutions or manufacturers can entrust an agency as the applicant to submit the appropriate application. (B) The provincial food and drug regulatory authorities should conduct formal review in five working days, and issue an acceptance notice of drug registration application if requirements are met. (C) After acceptance of the application, the provincial food and drug regulatory authority shall review the one-off import application in 20 working days, and issue an Approval for Drug Import if requirements are met; or issue a Notice of Review and Approval Comments if requirements are not met. Approval Document for Drug Import is valid for 12 months and it shall indicate the specific use of the imported control drugs while clarifying relevant accountability requirements. The Approvals shall be copied to CFDA and the provincial food and drug regulatory authorities in jurisdiction of the customs clearance port. For entrusted application, the Approvals shall be copied to the provincial food and drug regulatory authorities in charge of the entrusting party. III. Requirements for application dossiers: (A) Copies of legal registration certificates of the applicant (such as business license, organization code certificate, etc.). For entrusted application, the copies of legal registration certificates of the entrusting party, as well as the authorization certificate, shall be provided in addition. (B) The application report. It should include: Marketing status at home and abroad of the control drugs to be imported, and the sources, specific uses, quantity, use plan, and port of entry. The applicant shall provide a written commitment barring the marketing and use other than those applied. The above Application Reports and Commitments shall be stamped with the official seal of the applicant, or the entrusting party, in the case of entrusted application. (C) Proof documents of overseas marketing of the control drugs to be imported (such as package inserts of drugs marketed overseas, copies of approval certificates issued by drug regulatory authorities of the nations where the drugs are marketed or public information on the websites of such authorities, etc.). (D) Where the applicants are agents, they shall provide the review comments issued by the provincial food and drug 为目的的研究中用于对照药品的化学药品制剂或原料药 二 申报程序国家食品药品监督管理总局委托各省级食品药品监督管理部门负责办理研制过程中所需对照药品一次性进口的受理 审查及审批 具体申报程序如下 : ( 一 ) 符合适用范围条件的, 申请人按资料要求准备资料, 填写 进口药品批件申请表 ( 附件 1), 向所在地省级食品药品监督管理部门提出对照药品的一次性进口申请 研发机构或生产企业也可委托代理机构作为申请人提出相应申请 ( 二 ) 各省级食品药品监督管理部门应当在 5 个工作日进行形式审查, 符合要求的, 准予受理, 并出具受理通知书 ( 三 ) 受理后, 各省级食品药品监督管理部门在 20 个工作日内对一次性进口申请进行审查, 符合要求的, 发给 进口药品批件 ; 不符合要求的, 发给 审批意见通知件 进口药品批件 有效期为 12 个月, 批件应注明所进口对照药品的具体用途, 同时明确相关责任要求 批件抄送国家食品药品监管总局 通关口岸所在地省级食品药品监管部门 属于委托办理的, 同时抄送委托方所在地省级食品药品监管部门 三 申报资料要求 ( 一 ) 申请人机构合法登记证明文件复印件 ( 如营业执照 组织机构代码证等 ) 属于委托申请的, 另须提供委托人的合法登记证明文件复印件及委托证明文件 ( 二 ) 申请报告 内容应包括 : 拟申请进口对照药品的境内外上市情况 拟申请进口对照药品的来源 具体用途 数量 使用计划及拟进口药品的口岸 申请人书面承诺所进口药品不得用于上市销售及申请用途以外的其他用途 上述申请报告及承诺须加盖申请人公章, 申请人属于委托代理的, 由委托方提供上述材料 ( 三 ) 拟进口对照药品的国外获准上市证明材料 ( 可提供上市国家药品监管部门核发的批准证明文件复印件 境外上市的药品说明书或上市国家药品监管部门网站公开信息等 ) ( 四 ) 申请人属于委托代理的, 提供委托方研发机构或生产企业所在地省级食品药品监管部门出具的审查意见表 Volume IX

4 regulatory authorities in charge of the R&D institution of the entrusting party, or the manufacturing enterprises. IV. Requirements for import filing The control drugs should be imported via the import port stated in the Approval for Drug Import. Import filing shall be handled in accordance with the following procedures: (A) The applicants shall submit an application for Customs Clearance to the Port Food and Drug Administration, along with the following information: 1. The Approval for Drug Import of the imported drugs; 2. Copies of legal registration certificates of the applicant (such as business license, organization code certificate, etc.). For entrusted application, the copies of legal registration certificates of the entrusting party, as well as the authorization certificate, shall be provided in addition. 3. A copy of the Certificate of Origin; 4. A copy of the contract for goods; 5. Copies of packing list, Bill of Lading and freight invoice; 6. The patterns of package inserts, packages and labels (except for APIs and intermediates of formulations); 7. For drugs re-imported via other countries or regions, the applicant shall also submit all the purchase contracts, packing lists, Bill of Lading and freight invoices from country of origin to all re-exports. All of the above copies should be stamped with the official seal of the applicants. (B) The port food and drug administration should handle the import filing of control drugs as per relevant requirements of the Administrative Measures for Import of Drugs. The import review shall focus on the verification of Certificate of Origin, purchase contracts, invoices and other documents to confirm the true origin of imported control drugs. (C) The port food and drug administration shall grant import filing and issue Customs Clearance of Imported Drugs where all the information is reviewed as correct. (D) Applications for one-off import of control drugs for purpose of study can be exempted from port inspection. V. Other Requirements (A) The applicant shall be responsible for scientific and rational study of the imported control drugs, for their quality and safety, use management as well as risk prevention and treatment in the process of use, which shall be in strict accordance with the approved purposes. Where the applicant is an agent, the above responsibilities and obligations shall be borne by the entrusting party. (B) The imported control drugs for clinical trials cannot be used in the said settings until passed the test. The tests may be conducted by the applicants, or the Drug Control Institutions upon commission. One of the following standards can serve as the test standard: (1) the manufacturer's quality standards; (2) Standards collected in the current version of Pharmacopoeia of the People's Republic of China; (3) Standards proposed by the applicants that comply with the general requirements of the current version of Pharmacopoeia of the People's Republic of China. 四 进口备案要求拟进口的对照药品应从 进口药品批件 载明的药品进口口岸进口 进口备案按照以下程序办理 : ( 一 ) 申请人向口岸食品药品监督管理局提出申请办理 进口通关单, 并同时提供以下资料 : 1. 所进口药品的 进口药品批件 ; 2. 申请人机构合法登记证明文件复印件 ( 如营业执照 组织机构代码证等 ) 属于委托申请的, 另须提供委托人的合法登记证明文件复印件及委托证明文件 ; 3. 原产地证明复印件 ; 4. 货物合同复印件 ; 5. 装箱单 提运单和货运发票复印件 ; 6. 药品说明书及包装 标签式样 ( 原料药和制剂中间体除外 ); 7. 经其他国家或者地区转口的进口药品, 需要同时提交从原产地到各转口地的全部购货合同 装箱单 提运单和货运发票等 上述各类复印件应当加盖申请人公章 ( 二 ) 口岸食品药品监督管理局应按照 药品进口管理办法 的相关规定办理对照药品的进口备案 审查工作中, 加强对原产地证明文件 购货合同以及发票等文件的审核, 确认所进口对照药品的真实产地 ( 三 ) 口岸食品药品监督管理局审查全部资料无误后, 准予进口备案, 发出 进口药品通关单 ( 四 ) 研究用对照药品的一次性进口申请, 可不要求进行口岸检验 五 其他要求 ( 一 ) 申请人负责所进口对照药品在药物研究过程中的科学性和合理性, 承担所进口对照药品的质量安全 使用管理以及过程中的风险防控和处理, 严格按照批准的用途使用 申请人属于委托代理的, 由委托方承担上述责任与义务 ( 二 ) 用于临床试验的对照药品, 进口后经检验合格方可用于临床试验 申请人可自行检验, 也可委托药品检验所进行委托检验 检验标准可选用下列之一 :(1) 生产厂家的质量标准 ;(2) 中华人民共和国药典 现行版中收载的标准 ;(3) 申请人自拟标准, 且符合 中华人民共和国药典 现行版的通用要求 临床研究过程中及研究结束后, 申请 4 CHINA FOOD AND DRUG NEWSLETTER

5 The applicant shall promptly report the use of control drugs to the provincial food and drug regulatory authorities during the process of clinical trials or at the end of the study. Where the applicant is an agent, the above tasks shall be completed by the entrusting party. (C) The provincial food and drug regulatory authorities shall be responsible for daily supervision of the pharmaceutical R&D institutions and manufacturing enterprises within their respective administrative areas, focusing on supervision and verification of the use of control drugs in the process of drug study, while reinforced supervision shall be applied to control drugs for clinical trials to guarantee clinical drug safety. (D) This Announcement shall not apply to control drugs for narcotic drugs, psychotropic drugs, and biological products for clinical trials. (July 1, 2016) 人应及时向所在地省级食品药品监督管理部门报告相关使用情况 申请人属于委托代理的, 由委托方完成上述工作 ( 三 ) 各省级食品药品监督管理部门负责行政区域内药品研发机构和药品生产企业的日常监管, 对其药品研究过程中的进口对照药品的使用情况应加强监督与核查, 特别是用于临床试验的对照药品, 应予以重点监管, 保障临床用药安全 ( 四 ) 属于麻醉药品 精神药品 临床试验用生物制品的对照药品, 不适用本公告 ( ) CFDA and NHFPC issued the Notice on Implementing the Newly Revised Regulations on Management of Vaccine Circulation and Inoculation 国家食品药品监管总局 国家卫生计生委发布 关于贯彻实施新修订 < 疫苗流通和预防接种管理条例 > 的通知 The Regulations on Management of Vaccine Circulation and Inoculation (hereinafter referred to as Regulations), amended by the State Council, has been promulgated on April 23, To implement the Regulations, regulate the management of vaccine circulation and inoculation, and effectively safeguard the health rights and interests of people, on June 14, 2016, CFDA and NHFPC issued the Notice on Implementing the Newly Revised Regulations on Management of Vaccine Circulation and Inoculation, which notifies the issues related to strict regulation of the sales and purchasing behaviors of vaccines, the management of vaccine circulation in transitional period, the management of vaccine distribution, cold chain, traceability and use; to reinforce supervision and inspection of vaccine circulation and use, and strengthen inoculation and vaccine management capacity building. For filing requirements for agencies of foreign vaccine manufacturers, see Annex. (June 14, 2016) 国务院修订的 疫苗流通和预防接种管理条例 ( 以下简称 条例 ) 已于 2016 年 4 月 23 日公布实施 为贯彻落实 条例, 规范我国疫苗流通和预防接种管理, 切实维护广大人民群众健康权益, 2016 年 6 月 14 日, 国家食品药品监管总局 国家卫生计生委发布 关于贯彻实施新修订 < 疫苗流通和预防接种管理条例 > 的通知, 就严格规范疫苗销售和采购行为 严格过渡期疫苗流通管理 严格落实疫苗配送管理 严格落实疫苗冷链和追溯管理要求 严格规范疫苗使用管理 强化疫苗流通和使用的监督检查 加强预防接种和疫苗管理能力建设有关事宜进行了通知 附件为境外疫苗厂商代理机构备案要求 ( ) CFDA Approved 14 Applications for Drug Marketing in May 2016 国家食品药品监督管理总局 2016 年 5 月份共批准药品上市申请 14 件 On June 8, 2016, CFDA issued the Announcement on CFDA-approved Drugs for Marketing ([2016] No. 114), which states that: In May 2016, CFDA has approved 14 applications for drug marketing, wherein there are 13 for domestic chemicals, and 1 for imported chemicals. (June 8, 2016) 2016 年 6 月 8 日, 国家食品药品监督管理总局发布 总局批准上市药品公告 (2016 年第 114 号 ), 内容为 : 2016 年 5 月份共批准药品上市申请 14 件 其中, 国产化学药品 13 件, 进口化学药品 1 件 ( ) Volume IX

6 Food CFDA issued the Notice on Issues Pertaining to the Implementation of the Administrative Measures for Health Food Registration and Record Filling 食品 国家食品药品监督管理总局发布 关于实施 < 保健食品注册与备案管理办法 > 有关事项的通知 In order to implement the Administrative Measures for Health Food Registration and Record Filling (CFDA Order No. 22, hereinafter referred to as the Measures), effectively integrate registration and record filling, on June 30, 2016, CFDA issued the Notice on Issues Pertaining to the Implementation of the Administrative Measures for Health Food Registration and Record Filling, which notifies the relevant issues as follows: I.From July 1, 2016 onwards, all provincial food and drug regulatory authorities shall no longer accept applications for registration of health food or carry out sample sealing for health food registration test; and shall accept applications for health food record filling after promulgation of the Category of health food raw materials. II.For registration applications accepted prior to July 1, 2016, CFDA Administrative Service Center and the provincial food and drug regulatory authorities shall, in accordance with relevant provisions, submit all relevant materials to CFDA Center for Health Foods Evaluation before July 21. III.The provincial food and drug regulatory authorities shall organize the health food registration inspection agencies within their respective administrative areas to conduct statistics of products whose registration application have been accepted before July 1, 2016 but not yet completed inspection in accordance with the requirements set forth in the Schedule, and report the relevant summary forms to CFDA Center for Health Foods Evaluation prior to August 1, IV.In the implementation of the Measures, food and drug regulatory authorities at all levels shall strengthen the support for organizations, personnel, funding and technology, implement the Four Haves and Two Responsibilities, pay attention to collect important information and problems encountered in the implementation of the Measures, communicate and feed back in a timely manner, to ensure smooth transition and orderly integration of health food registration and supervision. (June 30, 2016) 为贯彻实施 保健食品注册与备案管理办法 ( 国家食品药品监督管理总局令第 22 号, 以下简称 办法 ), 做好注册与备案管理有关工作的衔接,2016 年 6 月 30 日, 国家食品药品监督管理总局发布 关于实施 < 保健食品注册与备案管理办法 > 有关事项的通知, 将有关事项通知如下 : 一 2016 年 7 月 1 日后, 各省级食品药品监督管理部门不再受理保健食品注册申请, 不再开展保健食品注册检验样品封样工作 ; 保健食品原料目录发布后, 受理保健食品备案申请 二 2016 年 7 月 1 日前已受理的保健食品注册申请, 总局行政受理机构和各省级食品药品监督管理部门应当按照有关规定在 7 月 21 日前将相关材料全部报送总局保健食品审评中心 三 各省级食品药品监督管理部门应当组织本行政区域内保健食品注册检验机构, 按照附表要求对 2016 年 7 月 1 日前已受理未完成检验的产品情况进行统计, 于 2016 年 8 月 1 日前将相关汇总表格报送总局保健食品审评中心 四 各级食品药品监管部门在贯彻落实 办法 过程中, 要加强机构 人员 经费和技术保障, 落实 四有两责, 注意收集 办法 执行过程中遇到的重要情况和问题, 及时沟通和反馈, 确保保健食品注册监管工作的平稳过渡和有序衔接 ( ) CFDA issued Announcement on Granting Transition Period for Registration and Management of Formula Foods for Special Medical Purposes 国家食品药品监督管理总局发布 关于给予特殊医学用途配方食品注册管理过渡期的公告 As the Provisions for Registration of Foods for Special Medical Purposes (CFDA Order No. 24) has come into effect from July 1, 2016, in order to protect the normal supply of formula foods for special medical purposes in China, on June 30, 2016, CFDA issued the Announcement on Granting Transition Period for Registration and Management of Formula Foods for Special Medical Purposes ([2016] No. 119), which reads as follows: Before January 1, 2018, the sales of formula foods for special medical purposes 特殊医学用途配方食品注册管理办法 ( 国家食品药品监督管理总局令第 24 号 ) 自 2016 年 7 月 1 日起施行, 为保障国内特殊医学用途配方食品的正常供应,2016 年 6 月 30 日, 国家食品药品监督管理总局发布 关于给予特殊医学用途配方食品注册 6 CHINA FOOD AND DRUG NEWSLETTER

7 that are approved for production in or import to China is allowed to the end of its shelf life. Since January 1, 2018, all formula foods for special medical purposes that are approved for production in or import to China shall obtain a registration certificate of formula foods for special medical purposes. (June 29, 2016) 管理过渡期的公告 (2016 年第 119 号 ), 就给予特殊医学用途配方食品注册管理过渡期公告如下 : 2018 年 1 月 1 日前, 经批准在我国境内生产或向我国境内出口的特殊医学用途配方食品, 可销售至其保质期结束 自 2018 年 1 月 1 日起, 在我国境内生产或向我国境内出口的特殊医学用途配方食品应当依法取得特殊医学用途配方食品注册证书 ( ) Medical Devices CFDA Approved the Registration of 123 Medical Devices in May 2016 In May 2016, CFDA has approved a total of 123 registration applications of medical devices. Among them, there are 58 domestic Class III medical devices, 27 imported Class III medical devices, and 38 imported Class II medical devices. (June 16, 2016) 医疗器械 2016 年 5 月国家食品药品监督管理总局批准注册医疗器械产品 123 个 2016 年 5 月, 国家食品药品监督管理总 局共批准注册医疗器械产品 123 个 其中, 境内第三类医疗器械产品 58 个, 进口第三 类医疗器械产品 27 个, 进口第二类医疗器 械产品 38 个 ( ) CFDA issued the Announcement on Carrying out Supervision and Random Inspection of Medical Device Clinical Trials 国家食品药品监督管理总局发布 关于开展医疗器械临床试验监督抽查工作的通告 To implement the requirements of the Opinions of the State Council on the Reform of the Review & Approval System for Drugs and Medical Devices (State Council [2015] No. 44), strengthen the supervision and administration of medical device clinical trials, CFDA will carry out supervision and inspection over the authenticity and compliance of clinical trial data in medical device registration applications under review, to investigate illegal activities in clinical trials, especially falsifications, and enhance the applicant's and clinical trial institution's legal awareness, and sense of integrity, responsibility and quality, on June 8, 2016, CFDA issued an Announcement on Carrying out Supervision and Random Inspection of Medical Device Clinical Trials ([2016] No. 98), which clarifies the inspection scope, rationale, procedures, results handling and other matters. For Key Points for On- Site Inspection of Medical Device Clinical Trials (2016) and Procedures for On-Site Inspection of Medical Device Clinical Trials (2016), see Annex. (June 8, 2016) 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 ) 要求, 加强医疗器械临床试验监督管理, 国家食品药品监管总局将对在审的医疗器械注册申请中的临床试验数据真实性 合规性开展监督检查, 查处临床试验违法违规尤其是弄虚作假行为, 强化申请人和临床试验机构的法律意识 诚信意识 责任意识和质量意识, 2016 年 6 月 8 日, 发布了 关于开展医疗器械临床试验监督抽查工作的通告 (2016 年第 98 号 ), 就检查范围 检查依据 检查程序 检查结果处理以及其他事项进行了明确 附件为医疗器械临床试验现场检查要点和医疗器械临床试验现场检查程序 (2016 年 ) ( ) Volume IX

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