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.
View summary of this report @ http://www.radiantinsights.com/research/latest-regulations-on-pharmaceutical-international-multi-center-clinical-trials-in-china
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 step by step.
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.
Read Sample report of this Category: http://www.radiantinsights.com/catalog/pharmaceutical
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. 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”.
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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. Access China Management Consulting Ltd hopes this
guidebook, based on full and accurate regulations, can guide overseas and
multinational pharmaceutical manufacturers and producers to achieve a
successful entry into the Chinese drug market, and smoothly operate their
products in China.
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