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

Chinese Clinical Imported and Overseas New Drugs - Guidebook for Review and Approval Procedures

Chinas 1.3 billion has been routed as the second largest economy in the global domain, with an increase in the dominance of the global economy. The country has been one of the largest in contributing to the worldwide growth in the financial crisis of 2008.

China is one of the fastest growing global economies with a one-fifth population in the world. Nowadays, China has become the worlds 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 opportunity 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.

Market Analysis

To capture the huge business opportunities of the Chinese healthcare market and seize a larger part of the 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.

Provides the latest description of the Chinese changing healthcare market landscape and rapidly changing regulatory framework as background for audience.
Introduces that review and approval procedures of overseas imported new drugs of Chinese clinical urgent demand are applicable to what scope of drug varieties.
Expounds the selection process of drug varieties.
Elaborates the details of the review and approval procedures of overseas imported new drugs of Chinese clinical urgent demand.
Expounds the Chinese drug regulatory authoritys requirements for application materials that overseas applicants apply for overseas imported new drugs of Chinese clinical urgent demand.
Expounds the duties and obligations of overseas pharmaceutical manufacturers for drugs exported to the Chinese healthcare market.
Elaborates the Chinese drug regulatory authoritys 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.
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 that Chinese drug regulatory authority is calling these overseas applicants to submit the application for marketing in China to the Chinese drug regulatory authority, Chinese drug regulatory authority will offer a dedicated pathway to expedite the review and approval

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. They 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.

 

Contents.1
Chapter 1 Executive Summary.3
Chapter 2 China’s Changing Healthcare Market Landscape and Rapidly Changing Regulatory Framework: A knowledge Background for Overseas and Multinational Pharmaceutical Manufacturers.5
2.1. China’s Changing Healthcare Market Landscape.5
2.2. What is Cause to Drive the Rapid Change of Regulatory Framework?.7
Chapter 3 Scope of Drug Variety for Review and Approval Procedures of Overseas Imported New Drugs for Clinical Urgent Demand.12
Chapter 4 Drug Variety Selection.13
Chapter 5 Review and Approval Procedures of Overseas Imported New Drugs for Clinical Urgent Demand.14
Chapter 6 Requirements for Application Materials.16
Chapter 7 Overseas Applicants Duties and Obligations for Drugs on Post-marketing in China.18
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.19
8.1. General Regulations of Communication and Exchange.20
8.2. Proposing and Deliberating Convene the Communication and Exchange Meetings with the CDE.21
8.3. Preparation for Communication and Exchange Meetings.23
8.4. Convening Communication and Exchange Meetings.24
8.5. Application Form, Materials and Minutes Template of Communication and Exchange Meeting.25
Annex 1 Application Form of Communication and Exchange Meeting.26
Annex 2 The Materials for Communication and Exchange Meeting.29
Annex 3 Communication and Exchange Meeting Minutes Template.32
Chapter 9 A List of Overseas Imported New Drugs for Chinese Clinical Urgent Demand.35
Table 9. List of Overseas Imported Drugs for Chinese Clinical Urgent Demand (The First Batch).38

 


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 Mentioned

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
Dompé 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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