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Chinese Pharmaceutical International Multi-Center Clinical Trials Industry Analysis

MarketReportsOnline.com adds "Latest Regulations on Pharmaceutical International Multi-Center Clinical Trials in China" report to its research store.

"China’s healthcare market is indispensable for overseas and multinational pharmaceutical companies, but Chinese regulations on pharmaceutical clinical trials are undergoing sharp changes. This is first time in history, Chinese pharmaceutical authorities officially issued a guidance on international multi-center clinical trials of drugs in China, which has begun to be implemented on March 1, 2015. To enter into Chinese lucrative drug market, the overseas and multinational pharmaceutical manufacturers must be compliance with this latest regulations. How do respond such challenges?  The overseas and multinational pharmaceutical anufacturers and their senior executive officers engaging in regulatory affairs must have a comprehensive and thorough knowledge of the Guidance on Chinese international multi-center clinical trials of drugs, and must be compliance with the latest regulations.

Complete report available at http://www.marketreportsonline.com/402196.html.

The organizations of this guidebook are arranged as follows.

Chapter 2 provides an overview of the Chinese regulatory authorities -- China Food and Drug Administration (CFDA) being responsible for application and approval for international multi-center clinical trials of drug registration to give the direction of gateway for application for approval of clinical trial of imported overseas drug registration.

Chapter 3 elaborates the background of promulgating Guidance. Chapter 4 introduces the applicable scope of Guidance.

Chapter 5 introduces the general requirements of international multi-center clinical trials of drugs in China. Chapter 6 elaborates a series of scientific issues that Guidance requires sponsors to be considered.

Chapter 7 elaborates a series of compliance issues that Guidance requires sponsors to be considered. Chapter 8 elaborates the clinical trial protocol amendment.

Chapter 9 introduces the requirements for using the data from international multi-center clinical trials to support the application for drug registration in China.

Chapter 10 introduces the authority, objects, contents, scope and requirements of Chinese drug regulatory authorities implementing inspection and verification on clinical trial sites.

Purchase a copy of this research report at USD 1495 (Single User License) http://www.marketreportsonline.com/contacts/purchase.php?name=402196.

Chapter 11 provides a comprehensively and thoroughly practical guidance for application and approval of pharmaceutical international multi-center clinical trials in China, from the knowledge preparation and operation preparation before application, the specific regulations on overseas applicant and application, to the practical operation of application for approval as well as registration and information disclosure of international multi-center clinical trials of drugs in China to smoothly navigate complex regulatory requirements step by step.

Chapter 12 provides a comprehensively comparative analysis to reveal the opportunities and challenges of international multi-center clinical trials of drugs in China, and to tell overseas and multinational pharmaceutical companies how to respond challenges.

Chapter 13 Appendices provide a complete set of full text in English of application forms involved in application for approval of pharmaceutical international multi-center clinical trials in China, which include “Application Form of Drug Registration”, “Application Form for Special Examination and Approval of New Drug Registration”, and “Application Form for Communication of Special Examination and Approval of New Drug Registration”. Browse complete Table of Contents at http://www.marketreportsonline.com/402196-toc.html.

Key Highlights

  • An overview of organizational structure of Chinese regulatory authorities -- China Food and Drug Administration (CFDA) for approval for international multi-center clinical trials in China to give the direction of gateway for clinical trials of imported drugs.
  • The background of promulgating Guidance.
  • The applicable scope of Guidance.
  • The general requirements of international multi-center clinical trials of drugs in China.
  • A series of scientific issues that overseas sponsors must be considered.
  • A series of compliance issues that overseas sponsors must be considered.
  • The detailed requirements for using the data from international multi-center clinical trials to support the application for imported overseas drug registration in China.
  • Chinese drug regulatory authorities how to implement the inspection and verification on clinical trial sites.
  • A comprehensively and thoroughly practical guidance for application and approval of pharmaceutical international multi-center clinical trials in China, from the knowledge preparation and operation preparation before application, the specific regulations on overseas applicant and application, to the practical operation of application for approval as well as registration and information disclosure of international multi-center clinical trials of drugs in China to smoothly navigate complex regulatory requirements step by step.
  • An entrie process of application and approval procedures for international multi-center clinical trials of drugs in China.

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