China
is one of the fastest growing global economies with a fifth population in the
world, and is one of the largest healthcare markets around the world. Along
with sustained economic and population growth as well as an ageing population,
Chinese healthcare market has maintained annually average growth rate above 16
% since 1990s. By 2013, total value of drugs on Chinese healthcare market has
reached RMB 1114 billion. On the Chinese healthcare market, imported drugs made
by overseas and multinational pharmaceutical manufacturers account for about
one fourth. It is estimated that total value of drugs on Chinese healthcare
market will be likely to be more than RMB 1450 billion by 2015, and will
surpass Japan to become the second largest drug market following the United
States. The Chinese healthcare market will attract more and more overseas
pharmaceutical manufacturers and producers to penetrate such market. Many
overseas and multinational pharmaceutical manufacturers are ardently conducting
clinical trials for their drugs in China to seize a larger part of such drug
market.
Access Full Report With TOC @ http://www.radiantinsights.com/research/latest-guidebook-for-conducting-pharma-clinical-trials-in-china-from-regulations-to-practice
However,
the Chinese approach to GCP compliance is unique, from the application and
approval process, the requirements for ethics committees, sponsors and
investigators to the application dossiers. To enter such a lucrative drug
market, overseas and multinational pharmaceutical manufacturers and producers
must have a comprehensive and thorough knowledge of the latest Chinese
regulations on clinical trials. Otherwise, the restrictive legal requirements
and approval delays eat up your development time and budget.
This
Latest Guidebook for Conducting Pharma Clinical Trials in China: From
Regulations to Practice not only
provided a comprehensive and thorough knowledge of the latest Chinese
regulations on clinical trials for imported drug registration but also introdued
the practical operation how to comply with the Chinese GCP to guide you use the
Chinese trial venues to keep drug development lean and agile in the
“post-patent-cliff” world step by step.
Download sample Copy of This Report at: http://www.radiantinsights.com/research/latest-guidebook-for-conducting-pharma-clinical-trials-in-china-from-regulations-to-practice#tabs-4
The
audiences of this guidebook are overseas pharmaceutical companies 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 conduct
smoothly clinical trials for their pharmaceutical products in China, and how to
comply with the Chinese GCP. After having skimmed through this guidebook,
audiences can clearly acquire not only a comprehensive and thorough knowledge
of Chinese regulations on clinical trials for imported drug registration but
also the practical operation how to comply with the Chinese GCP. 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 clinical
trial market, and smoothly operate clinical trial for their products in China.
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Report Highlights
An
overview of the Chinese applicable laws and regulations for drug clinical
trials.
An
overview of organizational structure of Chinese regulatory authorities for drug
clinical trials to give the direction of gateway for clinical trials of
imported drugs.
The
Chinese definitions of some basic terms used in application and approval
process of drug clinical trials for drug registration, and the Chinese unique
classification of drug registration, from the chemical drugs, biological
products, natural medicines to traditional Chinese medicines (TCMs).
Chinese
unique every party’s responsibilities in clinical trials for imported drug
registration.
An
entrie process of application and approval procedures for clinical trials of
imported drug registration.
The
full text in English of “Drug Registration Application Form for Imported Drug”.
The
practical guidance for clinical trials of imported chemical drug registration,
from the general and special regulations on clinical trials for imported
chemical drug registration, the requirements for data and materials of
application for approval of clinical trials for imported chemical drugs to the
data and materials submission of application for approval of clinical trials
for imported chemical drugs to smoothly navigate complex regulatory
requirements step by step.
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