生命科学指南之中国篇（英文版）.pdf

Life Sciences 2020CHINA 2 Law and Practice Contributed by: Alan Zhou, Coco Fan, Samantha He and Felicia Wang Global Law O!ce see p.18 Contents 1. Regulatory Framework p.4 1.1 Legislation and Regulation p.4 1.2 Challenging Decisions of Regulatory Bodies p.4 1.3 Di!erent Categories p.4 2. Clinical Trials p.4 2.1 Regulation of Clinical Trials p.4 2.2 Procedure for Securing Authorisation p.5 2.3 Public Availability of Databases p.5 2.4 Restriction for Using Online Tools p.5 2.5 Use of Resulting Data p.5 2.6 Further Requirements for the Creation of a Database p.6 3. Marketing Authorisations p.6 3.1 Assessment Process and Criteria p.6 3.2 Granting a Marketing Authorisation p.6 3.3 Period of Validity p.6 3.4 Procedure for Obtaining a Marketing Authorisation p.6 3.5 Access to Unauthorised Products p.7 3.6 Ongoing Obligations p.7 3.7 “ird-Party Access to Pending Applications p.8 3.8 Rules Against Illegal Medicines and/or Medical Devices p.8 3.9 Border Measures p.8 4. Manufacturing of Pharmaceutical and Medical Devices p.8 4.1 Manufacturing Plants p.8 5. Distribution of Pharmaceutical and Medical Devices p.8 5.1 Wholesale of Pharmaceutical and Medical Devices p.8 5.2 Di!erent Classi#cations p.9 6. Import and Export of Pharmaceuticals and Medical Devices p.9 6.1 Governing Law and Enforcement Bodies p.9 6.2 Importer of Record p.9 6.3 Prior Authorisations p.9 6.4 Non-tari! Regulations and Restrictions p.10 6.5 Provisions on Trade/Regulatory Facilitation p.10 7. Pharmaceutical and Medical Device Pricing and Reimbursement p.10 7.1 Price Control p.10 7.2 Price Comparison p.10 7.3 Reimbursement from Public Funds p.10 7.4 Cost Bene#t Analysis p.11 7.5 Prescriptions and Dispensing p.11 8. Digital Healthcare p.11 8.1 Rules for Medical Apps p.11 8.2 Rules for Telemedicine p.11 8.3 Promoting and/or Advertising on an Online Platform p.12 8.4 Electronic Prescriptions p.12 8.5 Online Sales p.12 8.6 Electronic Health Records p.12 9. Licensing p.13 9.1 Customary Deal Structures p.13 9.2 Dispute Resolution Provisions p.13 9.3 Diligence Obligations Provisions p.13 9.4 Change of Control p.13 9.5 Termination p.13 10. Patents p.14 10.1 Applicable Laws p.14 10.2 Second and Subsequent Medical Uses p.14 10.3 Patent Term Extension p.14 10.4 Patent Infringement p.14CHINA CONTENTS 3 10.5 Defences to Patent Infringement p.15 10.6 Bringing Proceedings p.15 10.7 Available Procedures p.16 11. IP Other !an Patents p.16 11.1 Counterfeit Pharmaceuticals and Medical Devices p.16 11.2 Restrictions on Trade Marks p.16 11.3 IP Protection for Trade Dress or Design p.16 11.4 Data Exclusivity p.16LAW AND PRACTICE CHINA Contributed by: Alan Zhou, Coco Fan, Samantha He and Felicia Wang, Global Law O!ce 4 1. Regulatory Framework 1.1 Legislation and Regulation Regulatory Framework “e primary statute regulating drugs in China is the Drug Administration Law (DAL). “e latest DAL revision has been e!ective since 1 December 2019. “e DAL, together with its implementing rules, referred to as the DAL Implementing Reg- ulations, governs various drug-related activities, including drug development, registration, manufacturing, and distribution. In order to address statutory requirements under the DAL for each of these activities, GxP (good practice) rules on laboratory and clinical trials, manufacturing and distribution as well as admin- istrative measures on drug registration, manufacturing, and dis- tribution, have also been enacted. In addition, product-speci#c laws, rules, and guidelines, such as the Vaccine Administration Law and the Administrative Measures on Blood Products, also apply to certain products. Some of the above-mentioned regula- tions and rules are under revision in order to re$ect the amend- ments under the revised DAL. “e Regulations for the Supervision and Administration of Medical Devices (RSAMD) has been enacted to set up a regu- latory framework for the administration of medical devices. “e development, registration, manufacturing, and distribution of medical devices are, like pharmaceuticals, regulated by GxP rules, and administrative measures. Also, product-speci#c rules and guidelines have been regulated and implemented. Regulatory Bodies “e State Administration for Market Regulation (SAMR) pro- vides market supervision, administration, and law enforcement for drugs and medical devices, in the areas of anti-monopoly, product quality safety, food safety, IP , fair competition and com- mercial bribery, issuance of business registrations, certi#cations and accreditations, among other things. “e National Medical Products Administration (NMPA), which is under the supervi- sion of the SAMR, regulates the registration, post-market risk management, administration of safety and quality, formulation of industrial/national standards, as well as the supervision and inspection of drugs and medical devices. “e National Health Commission (NHC) is mainly responsible for national health policies, the reform of the medical and health system, disease prevention and control, national drug policies and the national basic drug system. “e NHC supervises the National Administration of Traditional Chinese Medicine. “e National Healthcare Security Administration (NHSA) is mainly responsible for the implementation of the laws and regulations, policies and standards of medical insurance, the establishment of a mechanism for the prices of medical services with payment from medical insurance funds, the promotion of a market-oriented pricing mechanism for social medical services, and the establishment of a price information monitoring and release system. 1.2 Challenging Decisions of Regulatory Bodies “e decisions of the regulatory bodies that apply and enforce regulations of pharmaceuticals and medical devices can be challenged through an administrative review or administrative litigation. Citizens or legal entities who wish to challenge regulatory body decisions may #rst apply for administrative review. If they refuse to accept decisions made by the reviewing body, they may #le a lawsuit in court, unless the administrative review decisions are #nal as prescribed by law. Alternatively, they may institute pro- ceedings directly with a court, except in certain circumstances where laws and regulations provide that they must apply for an administrative review #rst. Once the court has accepted the case, they may no longer ask for an administrative review. In addition, the processes for challenging inspection and test results of pharmaceuticals and medical devices made by the inspection agencies under the NMPA are provided under the DAL and Regulations on the Supervision and Administration of Medical Devices. “e challenging party can apply with either the original inspection and agency or the inspection agency at a higher level for re-inspection. 1.3 Di“erent Categories China classi#es drugs as prescription drugs and non-prescrip- tion drugs (over-the-counter (OTC) drugs and regulates them di!erently. A patient must present prescriptions when purchas- ing prescription drugs, while OTC drugs can be bought without prescriptions. China further subdivides OTC drugs into Class A and Class B, according to their safety level. China classi#es medical devices into Class I, Class II and Class III according to their risk levels and expected purposes, structural features, methods of use, and other qualities. Class III medical devices are those with the highest risk level; their safety and e!ectiveness should be ensured by strict control and administration. 2. Clinical Trials 2.1 Regulation of Clinical Trials Clinical trials of pharmaceuticals are regulated by the NMPA s Administrative Measures for Drug Registration/Administra- tive Measures for the Registration of Medical Devices, Good Clinical Practice for Drug Trials/ Medical Device Trials (col-CHINA LAW AND PRACTICE Contributed by: Alan Zhou, Coco Fan, Samantha He and Felicia Wang, Global Law O!ce 5 lectively as GCPs) and an array of technical review standards and guidances. “e GCPs provide the general standard for the implementation of clinical trials, including study preparation and prerequisites, patient protection, dra% protocols, management of study mate- rials and documentations, study records and reports, data man- agement and statistical analysis, monitoring, and inspection. “e GCPs also explicitly de#ne the respective responsibilities of each responsible party in a clinical trial, including independent ethics committees, sponsors, investigators, and monitors. 2.2 Procedure for Securing Authorisation Clinical trials for drugs are generally required before the spon- sor applies for marketing authorisation, unless otherwise excluded by law (in special cases, for example drugs for rare and special diseases or innovative drugs for a serious disease that has no existing e!ective treatment). Clinical trials must themselves be authorised in advance by the Centre for Drug Evaluation (CDE) of the NMPA. “e general steps for securing clinical trial authorisation are: all clinical trials of pharmaceuticals shall be reviewed by ethical committee prior to initiation; prior to #ling with NMPA for clinical trial authorisation of a new drug, a sponsor shall apply for a pre-consultation meeting with the NMPA at which the sponsor is to present relevant data and dra% protocols, discuss concerns regarding pharmaceutical development and receive guidance; the sponsor may conduct a clinical trial for a pharmaceutical if it has not received any objection or query from the CDE within 60 days from the date when the application fees are paid upon acceptance of the application by CDE. Within the 60-day period, the CDE may require the sponsor to submit supplementary documents or not to conduct the clinical trials; the 60day review period begins again a%er the sponsor sub- mits the supplementary documents required by the CDE. If there is no objection from the CDE, the sponsor may imple- ment the clinical trial at the conclusion of the 60-day period. Similarly, if the sponsor is required to submit supplementary documents to recommence the 60-day review period, the sponsor can begin the clinical trial if there are no further objections or requests by the CDE during that period; if the CDE issues a notice to the sponsor indicating that it is not allowed to conduct the clinical trial, the sponsor may reply in writing with regard to all raised issues and reapply for approval of the clinical trial. “e CDE will further review and determine whether to approve that clinical trial; the sponsor is only allowed to implement the clinical trials upon receipt of the CDEs written approval. Class I medical devices and certain Class II and III medical devices are exempted from clinical trials. With respect to Class II and III medical devices that are not exempted from clinical trials, the sponsor may implement a clinical trial for a medical device if it has not received any notice from the Centre for Medi- cal Devices Evaluation of the NMPA (CMDE) within 60 days from the date when the application fees are paid upon accept- ance of the application by CDE. 2.3 Public Availability of Databases “e Drug Clinical Trial Registration and Information Platform (chinadrugtrials) hosted by the NMPA is a public database providing detailed information regarding clinical trials of pharmaceuticals for the purpose of registration, including the name of the pharmaceuticals, the name and purpose of the study, information about the sponsor, the standard for recruit- ing patients, important milestones, investigators, investigating institutes, detailed descriptions of members of the ethical com- mittee, and the current status of the clinical trial. “ere is no publicly available database for clinical trials of medi- cal devices in China. 2.4 Restriction for Using Online Tools “ere are no speci#c restrictions for using online tools to sup- port clinical trials, provided that the use of such online tools is subject to generally applicable laws and regulations with respect to personal information protection, online advertising, etc. 2.5 Use of Resulting Data Resulting data may contain personal information, including medical records, genetic resources, etc: personal information refers to information that can be used independently to identify or be combined with other information to identify a natural person. If resulting data from clinical trials include any personally identi#able infor- mation, that data will be regulated as personal data. Unless otherwise permitted by law, the transfer of personal data is subject to consent by the data subject. When transferring personal information outside the PRC, restrictions on cross- border data transfer shall apply; any medical records of patients and their copies retained and managed by a hospital shall be kept by such hospital. “e hospital shall not share the personal medical records with any third party unless the sharing is for scienti#c, educational, or research purposes; if resulting data include any information generated from human genetic resource materials, the Administrative Regulation on Human Genetic Resources applies. “is regulation provides restrictions on and requirements regard- ing the collection, use, storage or transfer of human genetic LAW AND PRACTICE CHINA Contributed by: Alan Zhou, Coco Fan, Samantha He and Felicia Wang, Global Law O!ce 6 resources in the PRC. Any collection, use, storage or transfer of genetic resources is subject to approval by the ethical committee and consent by data subjects. Stricter rules are applied to foreign entities, including foreign invested or controlled companies in the PRC. Filing with the Ministry of Science and Technology for the transfer of human genetic resources information to foreign entities is required. Utilisa- tion of human genetic resources by a foreign entity must be conducted in collaboration with a domestic entity and is subject to #ling or approval by the Ministry of Science and Technology. A foreign entity is prohibited from any storage, collection or transfer of human genetic resources. 2.6 Further Requirements for the Creation of a Database “e Guidelines for Clinical Trial Data Management issued by the NMPA set out the basic standards for the responsibility, quali#cation and training of parties responsible for data man- agement, and requirements for the design of management sys- tems, standardisation of