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

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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.

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.

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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.

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 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.

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. This is a huge business opportunities for the overseas pharmaceutical manufacturers. 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 review and approval procedures of overseas imported new drugs for Chinese clinical urgent demand. The Chinese regulatory approach is unique.

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Table of Contents:

Chapter  1  Executive  Summary.
Chapter  2  China’s  Changing  Healthcare  Market  Landscape  and  Rapidly  Changing  Regulatory  FraChapter  3  Scope  of  Drug  Variety  for  Review  and  Approval  Procedures  of  Overseas  Imported  NeChapter  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.

…….TOC Continued

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