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市場調查報告書

中國的緊急需求用海外進口新藥的審查、認證手續相關最新旅遊指南 (2019年版)

Latest Guidebook for Review and Approval Procedures of Overseas Imported New Drugs for Chinese Clinical Urgent Demand (2019 Edition)

出版商 Access China Management Consulting 商品編碼 803191
出版日期 內容資訊 英文 49 Pages
商品交期: 最快1-2個工作天內
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中國的緊急需求用海外進口新藥的審查、認證手續相關最新旅遊指南 (2019年版) Latest Guidebook for Review and Approval Procedures of Overseas Imported New Drugs for Chinese Clinical Urgent Demand (2019 Edition)
出版日期: 2019年03月01日內容資訊: 英文 49 Pages
簡介

本報告提供中國的緊急需求用海外進口新藥的審查、認證手續相關法規的相關調查,海外、多國籍的醫藥品廠商順利地獲得中國的銷售許可的指導。

第1章 摘要整理

第2章 中國的醫療市場環境及急速變化的法律規範:對海外、多國籍的醫藥品、醫療設備廠商來說的預備知識

  • 中國的變化的醫療市場環境
  • 促進法律規範的迅速變化的原因是什麼?

第3章 緊急需求用海外進口新藥的審查、認證手續醫藥品的種類

第4章 醫藥品種類的選擇

第5章 緊急需求用海外進口新藥的審查、認證手續

第6章 必要的申請資料

第7章 中國的醫藥品的上市後相關海外申請者的義務

第8章 醫藥品R&D及對技術審查的交流法規:為了確實進入優先的審查、認證的專用途徑的重要的最初階段

  • 資訊交流的一般法規
  • 開創跟CDE的資訊交流會的提案、審議
  • 資訊交流會的準備
  • 資訊交流會的召開
  • 資訊交流會的申請表格,文件及議事記錄模板

第9章 緊急需求用海外進口新藥的清單

目錄
Product Code: ACMC2019030008

China is one of the fastest growing global economies with one fifth population in the world. Nowadays, China has become the world's second largest healthcare market after the United States. Facing a gigantic population and rapid population aging, the Chinese government accelerated the priority approval of innovative drugs and relaxed the market access for overseas drugs to cope with the clinical urgent demand. In recent years, China's fast-track approval time is much shorter than any other country, which attracts more and more overseas pharmaceutical manufacturers to enter into the Chinese healthcare market. Undoubtedly the Chinese healthcare market of nearly 1.4 billion populations is a huge business opportunities for the overseas pharmaceutical manufacturers.

The Chinese “National Medical Products Administration (NMPA)” and the “National Health Commission (NHC)” jointly issued the latest “Review and Approval Procedures of Overseas Imported New Drugs for Clinical Urgent Demand” on October 23, 2018, which provided a dedicated pathway for priority review and approval of overseas drugs importing to Chinese healthcare market and clarified the specific review and approval procedures.

To capture the huge business opportunities of the Chinese healthcare market and seize a larger part of Chinese healthcare market, how do the foreign pharmaceutical manufacturers in compliance with the latest “Review and Approval Procedures of Overseas Imported New Drugs for Clinical Urgent Demand”? How do the overseas pharmaceutical manufacturers operate business smoothly in China? The overseas and multinational pharmaceutical manufacturers and their senior executive officers engaging in regulatory affairs need a thorough knowledge of the latest regulations for priority review and approval procedures of overseas imported new drugs for Chinese clinical urgent demand. The Chinese regulatory approach is unique.

The Latest Guidebook for Review and Approval Procedures of Overseas Imported New Drugs for Chinese Clinical Urgent Demand (2019 Edition) is an essential resource for overseas and multinational pharmaceutical manufacturers to successfully acquire the marketing authorization in China, which provided a detailed guidance for comprehensive knowledge of the latest regulations on review and approval procedures of overseas imported new drugs for Chinese clinical urgent demand to navigate regulatory requirements step by step.

This guidebook is organized as follows. Chapter 2 provides a latest description of the Chinese changing healthcare market landscape and rapidly changing regulatory framework as background for audience. Chapter 3 introduces that review and approval procedures of overseas imported new drugs of Chinese clinical urgent demand are applicable to what scope of drug varieties. Chapter 4 expounds the selection process of drug varieties. Chapter 5 elaborates the details of review and approval procedures of overseas imported new drugs of Chinese clinical urgent demand. Chapter 6 expounds the Chinese drug regulatory authority's requirements for application materials that overseas applicants apply for overseas imported new drugs of Chinese clinical urgent demand. Chapter 7 expounds the duties and obligations of overseas pharmaceutical manufacturers for drugs exported to Chinese healthcare market. Chapter 8 elaborates the Chinese drug regulatory authority's latest “Administrative Measures for Communication and Exchange on Drug Research and Development and Technical Review and Approval” to guide the overseas applicants to take the key first step entry into the dedicated pathway of priority review and approval procedures and to smoothly pass the review and approval procedures. Chapter 9 exhibits the first batch list of overseas imported new drugs of Chinese clinical urgent demand that has been selected by the Chinese drug regulatory authority, which is calling the overseas applicants to submit the application for marketing in China to the Chinese drug regulatory authority, also let the overseas pharmaceutical manufacturers understand the Chinese drug regulatory authority's distinctive regulatory current status.The list covers 40 drug varieties that have been approved to market in the United States, EU or Japan but that have not been yet marketed in China, and involves with 33 overseas pharmaceutical manufacturers.

The audiences of this guidebook are the overseas pharmaceutical manufacturers wishing to enter into the Chinese healthcare market, and the multinational pharmaceutical manufacturers have penetrated into the Chinese healthcare market, as well as their senior executive officers engaging in regulatory affairs expecting to understand the latest regulations on review and approval procedures of overseas imported new drugs for Chinese clinical urgent demand. After having skimmed through this guidebook, audiences can clearly acquire a comprehensive and thorough knowledge of the latest regulations on priority review and approval procedures of overseas imported new drugs for Chinese clinical urgent demand. Access China Management Consulting Ltd hopes this guidebook, based on the full and accurate regulations, can guide the overseas and multinational pharmaceutical manufacturers to achieve a successful entry into the Chinese healthcare market, and smoothly operate their companies in China.

Table of Contents

Chapter 1: Executive Summary

Chapter 2: China's Changing Healthcare Market Landscape and Rapidly Changing Regulatory Framework: A knowledge Background for Overseas and Multinational Pharmaceutical Manufacturers

  • 2.1. China's Changing Healthcare Market Landscape
  • 2.2. What is Cause to Drive the Rapid Change of Regulatory Framework?

Chapter 3: Scope of Drug Variety for Review and Approval Procedures of Overseas Imported New Drugs for Clinical Urgent Demand

Chapter 4: Drug Variety Selection

Chapter 5: Review and Approval Procedures of Overseas Imported New Drugs for Clinical Urgent Demand

Chapter 6: Requirements for Application Materials

Chapter 7: Overseas Applicants' Duties and Obligations for Drugs on Post-marketing in China

Chapter 8: Regulations on Communication and Exchange for Drug R&D and Technical Review and Approval: Key First Step to Successfully Enter the Dedicated Pathway for Priority Review and Approval Procedures

  • 8.1. General Regulations of Communication and Exchange
  • 8.2. Proposing and Deliberating Convene the Communication and Exchange Meetings with the CDE
  • 8.3. Preparation for Communication and Exchange Meetings
  • 8.4. Convening Communication and Exchange Meetings
  • 8.5. Application Form, Materials and Minutes Template of Communication and Exchange Meeting
  • Annex 1: Application Form of Communication and Exchange Meeting
  • Annex 2: The Materials for Communication and Exchange Meeting
  • Annex 3: Communication and Exchange Meeting Minutes Template

Chapter 9: A List of Overseas Imported New Drugs for Chinese Clinical Urgent Demand

  • Table 9. List of Overseas Imported Drugs for Chinese Clinical Urgent Demand (The First Batch)

List of Tables

  • Annex 1: Application Form of Communication and Exchange Meeting
  • Annex 2: The Materials for Communication and Exchange Meeting
  • Annex 3: Communication and Exchange Meeting Minutes Template
  • Table 9: List of Overseas Imported Drugs for Chinese Clinical Urgent Demand (The First Batch)

Companies Mentionned:

  • Janssen Biotech, Inc.
  • BioMarin Pharmaceutical Inc.
  • Actelion Pharmaceuticals Ltd.
  • Kyowa Hakko Kirin Co., Ltd.
  • Novartis Pharmaceuticals Corporation
  • Amgen Europe B.V.
  • Ariad Pharmaceuticals Inc.
  • Takeda Pharmaceuticals U.S.A., Inc.
  • Genzyme Corp
  • Novartis Pharma K.K.
  • Eli Lilly and Company
  • CELGENE CORP
  • Shire Orphan Therapies GmbH
  • Acorda Therapeutics Inc.
  • Genentech Inc.
  • Celgene Corporation
  • Regeneron Pharmaceuticals, Inc.
  • Prestwick Pharmaceuticals, Inc.
  • Dyax Corp.
  • Shire Human Genetic Therapies Inc.
  • Pfizer Ltd.
  • Aegerion Pharmaceuticals Inc.
  • United Therapeutics Corporation
  • Biogen Idec Ltd.
  • Teva Pharmaceutical Industries Ltd.
  • EUSA Pharma (UK) Limited
  • Dompe Farmaceutici, s.p.a.
  • Ultragenyx Pharmaceutical Company
  • GlaxoSmithKline Biologicals S.A.
  • Spark Therapeutics, Inc.
  • Cardiome UK Limited
  • Merck Sharp & Dohme Corp.
  • Gilead Sciences Inc.
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