Synopsis
Responding
to strong desire of overseas and multinational pharmaceutical manufacturers and
domestic pharmaceutical manufacturers to carry out research and development of
biosimilar products, this is first time in history, Chinese pharmaceutical
authorities, China Food and Drug Administration officially issued a technical
guidance for development and evaluation of biosimilars and defined the pathway
of license approval for biosimilars. Chinese pharmaceutical authorities require
that when conducting the research and development of biosimilar products in
China, the applicant of biosimilar registration application and its sponsor
should be in compliance with the Guidance and follow the pathway of license
approval of biosimilars.
How
to grasp the opportunity to smoothly conduct the research and development of
biosimilar products in China and speed up your biosimilar product approval
time? The overseas and multinational pharmaceutical manufacturers and their
senior executive officers engaging in regulatory affairs must have a
comprehensive and thorough knowledge of the latest Chinese guidance for
development, evaluation, license approval of biosimilars,
Read Complete Report With TOC @ http://www.radiantinsights.com/research/latest-chinese-guidance-for-development-evaluation-license-approval-of-biosimilars
Latest
Chinese Guidance for Development, Evaluation, License Approval of Biosimilars
provided a comprehensive and thorough knowledge of the latest Chinese guidance
for development, evaluation, license approval of biosimilars and guide you use
the Chinese trial venues to keep biosimilars development lean and to smoothly
operate in China.
Summary
China
has an indispensable biosimilar market for overseas and multinational
pharmaceutical companies. Historical data shows 40 per cent of China's $1.5bn
recombinant biologic product sales come from biosimilars, which have enjoyed
approximately 25-30 per cent CAGR over the past decade. If the market continues
to grow at 25 per cent per year, the biosimilar market could grow to $2bn,
around 20 per cent of the global biosimilar market by 2015. It is attracting
more and more overseas and multinational pharmaceutical manufacturers and
producers to penetrate such market.
Read Sample report of this Category: http://www.radiantinsights.com/catalog/healthcare
Responding
to strong desire of overseas and multinational pharmaceutical manufacturers and
domestic pharmaceutical manufacturers to carry out research and development of
biosimilar products, this is first time in history, Chinese pharmaceutical
authorities, China Food and Drug Administration officially issued a technical
guidance for development and evaluation of biosimilars (Trial Implementation)
on February 28, 2015, at the same time, announcement concerning implementing
the Guidance issued by the CFDA defined the pathway of license approval for
biosimilars. Chinese pharmaceutical authorities require that when conducting
the research and development of biosimilar products, the applicant of
biosimilar registration application and its sponsor should be in compliance
with the Guidance and follow the pathway of license approval of biosimilars.
There is a gigantically potential market of biosimilar products to meet the
demand for Chinese patients. However, In China, the process of application and
approval for clinical trials and marketing license approval of imported drug
registration is very complex, because the Chinese pharmaceutical authorities
administer and control this process by exorbitant administrative measures and
regulations, moreover, these exorbitant administrative measures and regulations
are variable and lack of transparency. In addition, the cultural difference
between China and Western countries as well as the language barriers will
increase the challenge faced by overseas and multinational pharmaceutical
manufacturers and producers.
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United States Respiratory Measurement Devices Market
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·
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Outlook to 2021 - http://www.radiantinsights.com/research/united-kingdom-respiratory-disposables-market-outlook-to-2021
How
to grasp the opportunity to smoothly conduct the research and development of
biosimilar products in China and speed up your biosimilar product approval
time? The overseas and multinational pharmaceutical manufacturers and their
senior executive officers engaging in regulatory affairs must have a
comprehensive and thorough knowledge of the latest Chinese guidance for
development, evaluation, license approval of biosimilars,
Latest
Chinese Guidance for Development, Evaluation, License Approval of Biosimilars
provided a comprehensive and thorough knowledge of the latest Chinese guidance
for development, evaluation, license approval of biosimilars and guide you use
the Chinese trial venues to keep biosimilars development lean and to smoothly
operate in China.
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