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Aarkstore Enterprise

Aarkstore : Latest Chinese Guidance for Development, Evaluation, License Approval
of Biosimilars

Browse Full Report
http://www.aarkstore.com/healthcare/118825/latest-chinese-guidance-for-developmentevaluation-license-approval-of-biosimilars

Published: May 2015| No. Of Pages: 48 Pages

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,
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 Chinas $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.
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.
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.
The organizations of this guidebook are arranged as follows. Chapter 2 introduces the applicable scope
of the Guidance and some definitions involving to the Guidance. Chapter 3 gives an overview of general
principles of development and evaluation of biosimilar products in China. Chapter 4 elaborates the
research and evaluation of pharmacy. Chapter 5 elaborates the requirements for non-clinical research
and evaluation. Chapter 6 elaborates the requirements for clinical research and evaluation in detail,
from clinical pharmacology study covering pharmacokinetics study, pharmacodynamics study and
(PK/PD) study, efficacy study, safety study, immunogenicity study to extrapolation of indications to
smoothly navigate complex regulatory requirements step by step. Chapter 7 introduces the regulatory
provisions for instructions of product and pharmacovigilance. Chapter 8 addresses the license approval
of biosimilars in China, from China’s registration category of biological products, specific pathway of
license approval for imported biosimilar registration to application dossiers and data for license approval
of biological products to guide you achieve a successful entry into the Chinese drug market, and
smoothly operate your biosimilar products in China. Chapter 9 Appendix provides the China’s
Application Form of Drug Registration in English.
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 clinical trials and marketing license approval of their biosimilar products in China, how
to comply with the latest Chinese guidance for development, evaluation, license approval of biosimilars.
After having skimmed through this guidebook, audiences can clearly acquire not only a comprehensive
and thorough knowledge of the latest Chinese guidance for development, evaluation, license approval
of biosimilars but also the practical operation how to comply with the latest Chinese guidance for
development, evaluation, license approval of biosimilars. 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.
Report Highlights
The applicable scope of Guidance.
An overview of general principles of development and evaluation of biosimilar products in China.
The detailed requirements for research and evaluation of pharmacy.
The detailed requirements for non-clinical research and evaluation.
The detailed requirements for clinical research and evaluation, from clinical pharmacology study
covering pharmacokinetics study, pharmacodynamics study and (PK/PD) study, efficacy study, safety
study, immunogenicity study to extrapolation of indications to smoothly navigate complex regulatory
requirements step by step.

An overview of marketing license approval of biosimilars in China, from China’s registration category of
biological products, specific pathway of license approval for imported biosimilar registration to
application dossiers and data for license approval of biological products to guide you achieve a
successful entry into the Chinese drug market, and smoothly operate your biosimilar products in China.
China’s Application Form of Drug Registration in English.
Scope
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.
Reasons To Buy
China has an indispensable biosimilar market for overseas and multinational pharmaceutical companies.
Historical data shows 40 per cent of Chinas $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.
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,
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.
Report Highlights
The applicable scope of Guidance.
An overview of general principles of development and evaluation of biosimilar products in China.

The detailed requirements for research and evaluation of pharmacy.
The detailed requirements for non-clinical research and evaluation.
The detailed requirements for clinical research and evaluation, from clinical pharmacology study
covering pharmacokinetics study, pharmacodynamics study and (PK/PD) study, efficacy study, safety
study, immunogenicity study to extrapolation of indications to smoothly navigate complex regulatory
requirements step by step.
An overview of marketing license approval of biosimilars in China, from China’s registration category of
biological products, specific pathway of license approval for imported biosimilar registration to
application dossiers and data for license approval of biological products to guide you achieve a
successful entry into the Chinese drug market, and smoothly operate your biosimilar products in China.
China’s Application Form of Drug Registration in English.

You can order full Report with TOC and for Sample page visit @
http://www.aarkstore.com/healthcare/118825/latest-chinese-guidance-for-development-evaluationlicense-approval-of-biosimilars

Aarkstore Enterprise

Table Of Content
Chapter 1 Executive Summary. 4
Chapter 2 Definitions and Applicable Scope.6
2.1. Definitions.6
A. Biosimilar Products. 6
B. Reference Products.7
C. Proposed Biosimilar Products.7
2.2. Applicable Scope.7
Chapter 3 General Principles of Development and Evaluation.8
3.1. Comparative Principle.8
3.2. Gradually Progressive Principle.8
3.3. Consistency Principle.9

3.4. Biosimilarity Evaluation Principle. 9
Chapter 4 Research and Evaluation of Pharmacy .10
4.1. General Considerations.10
4.2. Research of Production Technological Process.10
4.3. Analytical Methods.11
4.4. Characteristic Analyses.11
A. Analyses of Physicochemical Properties.11
B. Analyses of Biological Activities.12
C. Analyses of Purities and Impurities.12
D. Analyses of Immunological Characteristics .13
4.5. Quality Indexes.14
4.6. Stability Study.14
4.7. Other Studies.14
A. Host Cells.14
B. Preparation Prescription.15
C. Specification.15
D. Internal Packaging Materials.15
4.8. Evaluation of Similarity for Pharmaceutical Study.15

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About Aarkstore Enterprise
Aarkstore Enterprise is a leading provider of business and financial information and solutions worldwide.
We specialize in providing online market business information on market research reports, books,

magazines, conference at competitive prices, and strive to provide excellent and innovative service to
our customers.

Contact Details:
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Email: enquiry@aarkstore.com
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