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

BANGALORE, India, March 11, 2019 /PRNewswire/ -- China's fast-track approval time for Overseas Imported New Drugs, is much shorter than any other country, which attracts more and more overseas pharmaceutical manufacturers to enter 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.

This book 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.

China is one of the fastest growing global economies & 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.

This book 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 of Chinese clinical urgent demand to smoothly navigate regulatory requirements step by step.

See the full report : https://reports.valuates.com/sreport/ACCE-Book-32/Guidebook for Review and Approval Procedures of Overseas Imported New Drugs for Chinese Clinical Urgent Demand

Who should buy this report?         

  • Overseas pharmaceutical manufacturers wishing to enter into the Chinese healthcare market.
  • Multinational pharmaceutical companies have penetrated into the Chinese healthcare market.
  • Companies interested in understanding the latest Chinese regulations on priority review and approval procedures of overseas imported new drugs of Chinese clinical urgent demand.
  • Senior executive officers engaging in regulatory affairs for exporting drugs into Chinese healthcare market
  • Senior executive officers engaging in applying for registration for exporting drugs into Chinese healthcare market.

Report Highlights

  • A latest description for the China's changing healthcare market landscape and rapidly changing regulatory framework that let the overseas and multinational pharmaceutical manufacturers clearly understand the present-day realities of the Chinese healthcare market landscape and rapidly changing regulatory framework, and tell the overseas and multinational pharmaceutical manufacturers the opportunities and challenges.
  • The latest regulations on priority review and approval procedures of overseas imported new drugs of Chinese clinical urgent demand to smoothly navigate regulatory requirements step by step.
  • The scope and selection of drug variety for priority review and approval procedures of overseas imported new drugs for Chinese clinical urgent demand.
  • The detailed Chinese drug regulatory authority's requirements for application materials that the overseas applicants apply for overseas imported new drugs of Chinese clinical urgent demand. The overseas applicants should prepare the application materials in strict accordance with these requirements. 
  • The duties and obligations of the overseas applicants on the drugs on the post-marketing in China that are stipulated by the Chinese drug regulatory authority. The overseas applicants must undertake their duties and obligations on their drugs on the post-marketing in China. Otherwise, when the drug on post-marketing has been confirmed to have serious adverse reactions, the Chinese drug regulatory authority will take the emergency control measures to stop sale and use of the drug.
  • The detailed 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.
  • A full set of the English and Chinese bilingual application form, materials and minutes template for Communication and Exchange Meeting, which cover the "Application Form of Communication and Exchange Meeting" (annex 1), "The Materials for Communication and Exchange Meeting" (annex 2) and the "Communication and Exchange Meeting Minutes Template" (annex 3) to guide the overseas applicants how to communicate with the Chinese drug regulatory authority.
  • The first batch list of overseas imported new drugs for 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.

Total 33 Overseas pharmaceutical manufacturers are covered in this report :

  • 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.

For complete List of Companies Click Here: https://reports.valuates.com/sreport/ACCE-Book-32/Guidebook for Review and Approval Procedures of Overseas Imported New Drugs for Chinese Clinical Urgent Demand

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