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中国における医療機器向けGCP (医薬品の臨床試験の実施基準) の最新ガイドブック:外国の臨床試験データを中国における販売承認の申請に使用する方法

Latest Guidebook for China's Good Clinical Practice (GCP) for Medical Devices: How to Use Overseas Clinical Trial Data to Apply for Marketing Authorization in China

出版日: | 発行: Access China Management Consulting | ページ情報: 英文 122 Pages | 納期: 即日から翌営業日

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中国における医療機器向けGCP (医薬品の臨床試験の実施基準) の最新ガイドブック:外国の臨床試験データを中国における販売承認の申請に使用する方法
出版日: 2019年06月18日
発行: Access China Management Consulting
ページ情報: 英文 122 Pages
納期: 即日から翌営業日
  • 全表示
  • 概要
  • 目次
概要

当レポートでは、中国における医療機器の販売承認手続きに際して、外国の臨床試験データを用いて申請する方法について調査し、規制当局、外国の申請者に対する特別規制の概要、規制当局との連絡手段、関連フォーム・ドキュメント、申請の実践的ガイダンスなどをまとめています。

第1章 エグゼクティブサマリー

第2章 中国における医療機器向けGCP (医薬品の臨床試験の実施基準)

第3章 一般規制

第4章 被験者の権利・利益の保証

第5章 治験プロトコル

第6章 倫理委員会の責任

第7章 スポンサーの責任

第8章 治験機関・治験責任医師の責任

第9章 報告書の記録

第10章 治験用医療機器の管理

第11章 基本書類の管理

第12章 医療機器治験の検査ポイントおよび中国の医療機器向けGCPに準拠した判断

第13章 外国の医療機器メーカー向け特別規則を担当する中国の医薬品規制当局

第14章 外国の医療機器治験データを承認するための基本原則を担当する中国の医薬品規制当局

第15章 外国の医療機器治験データを承認するための基準を担当する中国の医薬品規制当局

第16章 外国の医療機器治験データを承認するために考慮される要因・技術要件を担当する中国の医薬品規制当局

第17章 外国の申請者が医療機器技術審査センター (CMDE) と双方向的な対話を通じて申請する方法

第18章 外国の申請者が医療機器技術審査センター (CMDE) と議事録の作成・会議を通して情報交換する方法

第19章 外国の申請者とCDMEの間の情報交換に関連したフォーム・ドキュメントテキスト

第20章 中国の医療機器向けGCPに関連する典型的なドキュメントテキスト

目次
Product Code: ACMC2019060118

In recent years, China's healthcare market landscape and regulatory framework is undergoing rapid changes. Facing a gigantic population and rapid population aging as well as growing medical care demand, the Chinese government, on one side, accelerated the priority approval of innovative drugs and medical devices and relaxed the market access for overseas drugs and medical devices, on other side, intensified the supervision and administration for drugs and medical devices on the post-marketed and the marketing authorization approval. In January 2018, predecessor of the National Medical Products Administration (NMPA), China Food and Drug Administration (CFDA) issued the "Technical Guideline for Accepting Overseas Clinical Trial Data of Medical Devices" to attempt speeding up marketing authorization approval for overseas medical devices in China. At present, National Medical Products Administration (NMPA) is firmly enforcing this Guideline. Indubitably, this is an opportunity that the foreign medical device manufacturers let their medical devices successful entry the Chinese healthcare market. However, the Guideline clearly stated that overseas clinical trial data should not only comply with the ethical principles, legal principles and scientific principles but also the China's GCP for Medical Devices. The Guideline elaborated the Chinese Drug Regulatory Authority on the considering factors and technical requirements for accepting overseas clinical trial data from the aspects of technical review requirements, differences of trial population and clinical trial conditions. In fact, during in the process of granting marketing authorization approval for overseas medical devices in China, not only the overseas clinical trial data of medical devices submitted by the overseas medical device manufacturer should comply with the China's GCP for Medical Devices, but also the overseas medical device manufacturer should designate an agency with legal person status within the territory of China or its representative office stationed in China to act as its agent to apply for communication and exchange with the Center for Medical Device Evaluation of NMPA (hereinafter called as CMDE). If the overseas medical device manufacturer can reach a consensus with the CMDE on overseas clinical trial data of medical devices submitted, then the overseas medical device manufacturer has got half the results for marketing authorization approval. All these efforts, however, must be established on base complying with the China's GCP for Medical Devices and the considering factors and technical requirements for overseas clinical trial data by Chinese Drug Regulatory Authority. Chinese regulatory approach is unique, which is different from that of US-EU. Chinese Drug Regulatory Authority administers and controls over this procedure of granting marketing authorization approval for overseas medical devices by exorbitant administrative measures and complex regulations. Moreover, the cultural difference between China and Western countries as well as the language barriers will increase the challenge faced by overseas medical device manufacturers. As a result, in order to smoothly pass this procedure of granting marketing authorization approval by submitted the overseas clinical trial data of medical devices, the overseas medical device manufacturers and their senior executive officers engaging in regulatory affairs need a comprehensive and thorough knowledge of China's GCP for Medical Devices.

The aim of this Guidebook is to guide the overseas medical device manufacturers how to acquire a comprehensive and thorough knowledge of China's GCP for Medical Devices, and how to use the overseas clinical trial data to apply for marketing authorization in China for overseas medical devices.

"Latest Guidebook for China's Good Clinical Practice (GCP) for Medical Devices: How to Use Overseas Clinical Trial Data to Apply for Marketing Authorization in China" is an essential resource for overseas medical device manufacturers to use overseas clinical trial data to successfully apply for marketing authorization in China for overseas medical devices, which provided not only a comprehensive knowledge of the latest Chinese GCP for Medical Devices, but also a detailed guidance of practical operation how use overseas clinical trial data to apply for marketing authorization in China for overseas medical devices, and in compliance with the Chinese Drug Regulatory Authority on the considering factors and technical requirements for overseas clinical trial data, including how establish an interactive mechanism between the overseas medical device manufacturers and the CMDE to reduce risk from the review uncertainty and approval delays that avoid to exhaust overseas applicant's time and energy.

This Guidebook is composed of three parts. The organizations of this guidebook are arranged as follows. Part One China's Good Clinical Practice for Medical Devices. Chapter 2 introduces the general regulations of the Chinese GCP for medical devices. Chapter 3 elaborates the preparation before clinical trial. Chapter 4 expounds the guarantee of rights and interests of subjects. Chapter 5 expounds the clinical trial protocol. Chapter 6 elaborates the responsibilities of ethics committee. Chapter 7 elaborates the responsibilities of sponsor. Chapter 8 elaborates the responsibilities of clinical trial institutions and investigators. Chapter 9 expounds the records and reports for clinical trial. Chapter 10 expounds the management of investigational medical devices for clinical trial. Chapter 11 expounds the management of basic documents for clinical trial. Chapter 12 elaborates the inspection key points for medical device clinical trial and the principles of judgment in compliance with the Chinese GCP for medical devices. Part Two Guidance of Practical Operation for Using Overseas Clinical Trial Data to Apply for Marketing Authorization in China. Chapter 13 elaborates the Chinese Drug Regulatory Authority on special regulations for overseas medical device manufacturers. Chapter 14 expounds the Chinese Drug Regulatory Authority on basic principles for accepting overseas clinical trial data. Chapter 15 expounds the Chinese Drug Regulatory Authority on criteria for accepting overseas clinical trial data. Chapter 16 expounds the Chinese Drug Regulatory Authority on the considering factors and technical requirements for accepting overseas clinical trial data. Chapter 17 elaborates how overseas medical device manufacturers apply for an interactive mechanism of communication and exchange with the CMDE. Chapter 18 elaborates how overseas medical device manufacturers communicate and exchange with the CMDE to reach the minutes of the communication and exchange meeting. Part Three Appendices including a full set of the English and Chinese bilingual application forms that are stipulated by the Center for Medical Device Evaluation (CMDE) of NMPA, and a full set of the English and Chinese bilingual exemplary document texts that are stipulated by the Chinese Drug Regulatory Authority, which are the essential documents to support China's GCP for Medical Devices. Chapter 19 Form and Document Text relating to the communication and exchange between the overseas medical device manufacturer and the CMDE, including the "Application Form of Communication and Exchange Meeting for Pre-Clinical Trial Approval Application" and "Template of Minutes for Communication and Exchange Meeting". Chapter 20 Exemplary Document Texts relating to China's GCP for Medical Devices, including the "Ethical Review and Approval Form of Application for Medical Device Clinical Trial", "Text of Informed Consent Form", "Text of Case Report Form for Medical Device Clinical Trial", "Text of Clinical Trial Protocol for Medical Device", "Text of Clinical Trial Report of Medical Device", and "Basic Document Directory for Clinical Trial of Medical Device that must be Preserved".

The audiences of this guidebook are overseas medical device manufacturers wishing to enter into the Chinese medical device market and multinational medical device companies have penetrated into the Chinese medical device market and their senior executive officers engaging in regulatory affairs expecting to understand how to use the overseas clinical trial data to apply for marketing authorization in China for their overseas medical devices, how to apply for clinical trials for their overseas medical devices in China, and how to comply with the latest Chinese GCP for Medical Devices to successfully apply for marketing authorization in China for their overseas medical devices.

After having skimmed through this guidebook, audiences can clearly acquire not only a comprehensive knowledge of the latest Chinese GCP for Medical Devices but also the guidance of practical operation how to use the overseas clinical trial data to apply for marketing authorization in China for their overseas medical devices. Access China Management Consulting Ltd hopes this guidebook, based on full and accurate regulations, can guide overseas and multinational medical device manufacturers and producers to achieve a successful entry into the Chinese medical device market and smoothly operate their business in China.

Table of Contents

Chapter 1 Executive Summary.

Part One China's Good Clinical Practice (GCP) for Medical Devices.

Chapter 2 General Regulations.

  • 2.1. General Regulations.
  • 2.2. Definitions.

Chapter 3 Preparation before Clinical Trial.

Chapter 4 Guarantee of Rights and Interests of Subjects.

Chapter 5 Clinical Trial Protocol.

Chapter 6 Responsibilities of Ethics Committee.

Chapter 7 Responsibilities of Sponsor.

Chapter 8 Responsibilities of Clinical Trial Institutions and Investigators.

Chapter 9 Records and Reports.

Chapter 10 Management of Investigational Medical Devices .

Chapter 11 Management of Basic Documents.

Chapter 12 Inspection Key Points for Medical Device Clinical Trials and Principles of Judgment in Compliance with China's GCP for Medical Devices.

  • 12.1. Inspection Key Points and Content for Medical Device Clinical Trials.
    • Table 12.1. Inspection Key Points and Content for Medical Device Clinical Trials.
  • 12.2. Principles of Judgment in Compliance with China's GCP for Medical Devices.

Part Two Guidance of Practical Operation for Using Overseas Clinical Trial Data to Apply for Marketing Authorization in China.

  • Chapter 13 Chinese Drug Regulatory Authority on Special Regulations for Overseas Medical Device Manufacturers.
  • Chapter 14 Chinese Drug Regulatory Authority on Basic Principles for Accepting Overseas Clinical Trial Data for Medical Devices.
  • Chapter 15 Chinese Drug Regulatory Authority on Criteria for Accepting Overseas Clinical Trial Data for Medical Devices.
  • Chapter 16 Chinese Drug Regulatory Authority on Considered Factors and Technical Requirements for Accepting Overseas Clinical Trial Data for Medical Devices.
  • Chapter 17 How Overseas Applicants Apply for an Interactive Mechanism of Communication and Exchange with the CMDE.
  • Chapter 18 How Overseas Applicants Communicate and Exchange with the CMDE to Conclude the Minutes of Communication and Exchange Meeting.

Part Three Appendices.

Chapter 19 Form and Document Text relating to Communication and Exchange between the Overseas Applicant and the CMDE.

  • Annex 1 Application Form of Communication and Exchange Meeting for Pre-Clinical Trial Approval Application.
  • Annex 2 Communication and Exchange Meeting Minutes Template.

Chapter 20 Exemplary Document Texts relating to China's GCP for Medical Devices.

  • Annex 3 Exemplary Text of Ethical Review and Approval Form of Application for Medical Device Clinical Trial.80
  • Annex 4 Exemplary Text of Informed Consent Form.
  • Annex 5 Exemplary Text of Case Report Form for Medical Device Clinical Trial.
  • Annex 6 Exemplary Text of Clinical Trial Protocol.
  • Annex 7 Exemplary Text of Clinical Trial Report.
  • Annex 8 Basic Document Directory for Clinical Trial of Medical Device that must be Preserved.

List of Tables

  • Annex 1 Application Form of Communication and Exchange Meeting for Pre-Clinical Trial Approval Application
  • Annex 2 Communication and Exchange Meeting Minutes Template.
  • Annex 3 Exemplary Text of Ethical Review and Approval Form of Application for Medical Device Clinical Trial
  • Annex 4 Exemplary Text of Informed Consent Form
  • Annex 5 Exemplary Text of Case Report Form for Medical Device Clinical Trial
  • Annex 6 Exemplary Text of Clinical Trial Protocol
  • Annex 8 Basic Document Directory for Clinical Trial of Medical Device that must be Preserved
    • Table 12.1. Inspection Key Points and Content for Medical Device Clinical Trials.
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