2015 Regulations on Pharmaceutical International Multi-Center Clinical Trials in China

May 22, 2015, 07:57 ET from Research and Markets

DUBLIN, May 22, 2015 /PRNewswire/ --Research and Markets

(http://www.researchandmarkets.com/research/3rthk2/latest) has announced the addition of the "Latest Regulations on Pharmaceutical International Multi-Center Clinical Trials in China" report to their offering.

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. The guidance provides an opportunity to reduce risk from the examination uncertainty and approval delays to eat up your time and energy to achieve a successful entry into such a lucrative drug market, and to avoid trouble for your business smoothly in China. The overseas and multinational pharmaceutical manufacturers must be compliance with the latest regulations.

Latest Regulations on Pharmaceutical International Multi-Center Clinical Trials in China provided a comprehensive and thorough knowledge of the Guidance on international multi-center clinical trials of drugs in China and guide you use the Chinese trial venues to keep drug development lean and to smoothly operate in China.

The audiences of this guidebook are overseas pharmaceutical manufacturers wishing to enter into the Chinese drug market, and multinational pharmaceutical companies have penetrated into the Chinese drug market, and their senior executive officers engaging in regulatory affairs expecting to understand how to apply for international multi-center clinical trials and registration of their pharmaceutical products in China, how to comply with the latest guidance on international multi-center clinical trials of drugs in China.

After having skimmed through this guidebook, audiences can clearly acquire not only a comprehensive and thorough knowledge of the latest guidance on international multi-center clinical trials of drugs in China but also the practical operation how to comply with the latest guidance on international multi-center clinical trials of drugs in China.

Key Topics Covered:

Chapter 1 Executive Summary

Chapter 2 An Overview of Chinese Regulatory Authorities for Drug Clinical Trials

Chapter 3 Background

Chapter 4 Applicable Scope

Chapter 5 General Requirements

Chapter 6 Consideration for Scientific Issues

Chapter 7 Consideration for Compliance Issues

Chapter 8 Clinical Trial Protocol Amendment

Chapter 9 Application for Drug Registration

Chapter 10 Inspection and Verification on Sites

Chapter 11 Practical Guidance for Application and Approval of Pharmaceutical International Multi-Center Clinical Trials in China

Chapter 12 A Comprehensive Analysis

For more information visit http://www.researchandmarkets.com/research/3rthk2/latest

Media Contact: Laura Wood , +353-1-481-1716, press@researchandmarkets.net

SOURCE Research and Markets



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