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

$750.00
By:
, Published: May-2015

Executive 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 bios.....

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

$1,495.00
By:
, Published: Mar-2015

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, th.....

Chinese Special Examination and Approval Procedures for Innovative Medical Devices: speed up overseas innovative medical devices entry into Chinese market

$750.00
By:
, Published: Jan-2015

China’s regulatory framework for medical devices is undergoing radical changes. 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. Among them, medical devices repres.....

Guide to Prepare Application Dossiers for Oversea Medical device registration and recordation in China (2014 Edition)

$1,250.00
By:
, Published: Nov-2014

Executive Summary

The Chinese medical device market is one of segment market of the most growth potentiality, which is attracting more and more overseas medical device manufacturers and producers to penetrate such market. It is estimated that Chinese medical device market will be likely to be more than 340 billion RMB (about 57 billion US dollars) by 2015, and will surpass Japan to become the second largest medical device market behind t.....

Latest Guidebook for Conducting Medical Device Clinical Evaluation and Clinical Trial in China: From Regulations to Practices (2014 Edition)

$1,495.00
By:
, Published: Oct-2014

Executive Summary

China’s regulatory framework for medical devices is undergoing radical changes. The country’s new leaders have recognized that the regulations for supervision and administration of medical devices are far from perfect along with rapid population growth and thriving economy over the past 30 years. Chinese state council issued the latest “Regulations for the Supervision and Administration of Medical Devices” on February 1.....

Latest Chinese Guidebook for Application and Approval of Imported In-vitro Diagnostic Reagent Registration: From Regulations to Practices (2014 Edition)

$1,495.00
By:
, Published: Sep-2014

China’s regulatory framework for in-vitro diagnostic reagents is undergoing earthshaking changes. The country’s new leaders have recognized that the regulations for supervision and administration of in-vitro diagnostic reagents are far from perfect along with rapid population growth and thriving economy over the past 30 years. Chinese state council issued the latest “Regulations for the Supervision and Administration of Medical Devices” on Feb.....

Latest Guidebook for Conducting Pharma Clinical Trials in China: From Regulations to Practice (2014 Edition)

$1,495.00
By:
, Published: Aug-2014

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.....

Latest Chinese Guidebook for Application and Approval of Imported Medical Device Registration: From Regulations to Practices (2014 Edition)

$1,250.00
By:
, Published: Aug-2014

Now, Chinese regulations on medical devices are undergoing earthshaking changes. China’s new leaders have recognized that the regulations for supervision and administration of medical devices are far from perfect along with rapid economic and population growth over the pasted three decades. Chinese state council issued the latest “Regulations for the Supervision and Administration of Medical Devices” to try to completely change such imperfect.....

Chinese guidebook for Adverse Drug Reaction Reporting and Monitoring Regulations (2014)

$750.00
By:
, Published: Mar-2014

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, 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 .....

Latest guidebook for Chinese Drug Recall Regulations (2014 Edition)

$750.00
By:
, Published: Mar-2014

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, 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 .....

Latest guidebook for Chinese Medical Device Recall Regulations (2014 Edition)

$750.00
By:
, Published: Feb-2014

Summary

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, Chinese healthcare market has maintained annually average growth rate above 16 % since 1990s. Among them, medical devices represented dynamical growth since 2000s. By 2013, total value of medical devices on Chinese healthcare .....

Chinese guidebook for Medical Device Adverse Event Reporting and Monitoring Regulations (2014 Edition)

$750.00
By:
, Published: Jan-2014

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, Chinese healthcare market has maintained annually average growth rate above 16 % since 1990s. Among them, medical devices represented dynamical growth since 2000s. By 2013, total value of medical devices on Chinese healthcare market has rea.....

China Pharmaceutical Guidebook: (2013 Edition) Latest Chinese Regulations for Imported Drug Registration 2013 Edition Material and Clinical Trial Requirements of Application and Approval for Imported Drug Registration: A Guidebook of Registration Applic

$1,495.00
By:
, Published: Jun-2013

Executive Summary

China possesses a fourth population in the world and has one of the largest drug markets round the world. By 2012, sales on the Chinese drug market have reached RMB 926.1billion (about US$147 billion) reported by the «2012: Report of China Pharmaceutical Market» published by Chinese Academy of Social Sciences. It is estimated that it will exceed RMB 1,000 billion by 2013. A series of factors, such as an increasingly age.....

China Pharmaceutical Guidebook Series (3) 2013 Edition Material and Clinical Trial Requirements of Application and Approval for Imported Drug Registration: A Guidebook of Registration Application for Imported Biological Products

$750.00
By:
, Published: May-2013

The biopharmaceutical industry is one of the burgeoning industries. In the field of biopharmaceuticals, vast knowledge awaits people to explore. The biopharmaceuticals are diversified and complex. In China, the development of biopharmaceutical industry is far behind the developed countries. The requirements of materials and clinical trials for registration application of biopharmaceuticals stipulated by the Chinese pharmaceutical authority are.....

China Pharmaceutical Guidebook Series (4) 2013 Edition Material and Clinical Trial Requirements of Application and Approval for Imported Drug Registration: A Guidebook of Registration Application for Imported Traditional Chinese Medicines and Natural Med

$750.00
By:
, Published: May-2013

The traditional medicines in Orient, especially, the traditional Chinese medicines are always regarded by occidental as mysterious medicines. Until today not only the chemical composition of traditional Chinese medicines almost can not been expressed by a precise chemical structural formula, but also the indications of the majority of traditional Chinese medicines still can not been clearly described by the modern medical terminologies. How th.....

China Pharmaceutical Guidebook Series (1)_ 2013 Edition Latest Chinese Regulations for Imported Drug Registration: A Comprehensive Guidebook for Foreign Pharmaceutical Companies

$750.00
By:
, Published: Apr-2013

"China possesses a fourth population in the world and has one of the largest drug markets round the world. By 2012, sales on the Chinese drug market have reached RMB 926.1billion (about US$147 billion) reported by the «2012: Report of China Pharmaceutica

China Pharmaceutical Guidebook Series (2) 2013 Edition Material and Clinical Trial Requirements of Application and Approval for Imported Drug Registration: A Guidebook of Registration Application for Imported Chemical Drugs

$750.00
By:
, Published: Apr-2013

Since the reform and open door policy implemented by Chinese authorities in the late 1970s, the door of the Chinese drug market began opening up to the world step by step, which gave a fillip to the imported drugs from overseas pharmaceutical manufacturers and producers. By 2012, sales of imported drugs have shared one fourth on the Chinese drug market. As China joins the World Trade Organization (WTO) and integrates more completely into the g.....

China Pharmaceutical Guidebook Series (1) 2013 Edition Latest Chinese Regulations for Imported Drug Registration: A Comprehensive Guidebook for Foreign Pharmaceutical Companies

$750.00
By:
, Published: Apr-2013

China possesses a fourth population in the world and has one of the largest drug markets round the world. By 2012, sales on the Chinese drug market have reached RMB 926.1billion (about US$147 billion) reported by the «2012: Report of China Pharmaceutical Market» published by Chinese Academy of Social Sciences. It is estimated that it will exceed RMB 1,000 billion by 2013. A series of factors, such as an increasingly ageing population, acceler.....

Latest Guide to Chinese Medical Device GMP Regulations

$750.00
By:
, Published: Mar-2013

China is one of the fastest growing global economies with a fourth population in the world, and is one of the largest healthcare markets around the world. Along with sustained economic and population growth, Chinese healthcare market has maintained annually average growth rate above 16 % since 1990s. Among them, medical devices represented dynamical growth since 2000s. By 2010, total value of medical devices on Chinese healthcare market has re.....

Latest Guide to Chinese Pharmaceutical GMP Regulations

$750.00
By:
, Published: Jul-2012

China possesses a fourth population in the world and has one of the largest drug markets round the world. By 2011, sales on the Chinese drug market have reached RMB 1550 billion (about US$246 billion), an increase of 7.08 fold over 2000 level. A series of factors, such as an increasingly ageing population, accelerating growth of urban population as well as expansion of healthcare covering urban and rural will grow the Chinese drug market with .....

Latest Chinese Guide to Industrial Access for Foreign Companies and Investors

$400.00
By:
, Published: May-2012

Latest Chinese Guide to Industrial Access for Foreign Companies and Investors published by Access China Management Consulting Ltd provides the detailed guidance of latest Chinese industrial policies on license of industrial access for foreign companies and investors.

The Chinese government authorities issued the revised edition of 2011 for Catalogue for the Guidance of Foreign Investment Industries on December 24, 2011, which came into f.....

Guidebook Series for Investing in China (Second Edition)

$4,800.00
By:
, Published: Apr-2012

Access China Management Consulting Ltd has worked hard to the second edition of the Guidebook Series for Investing in China in order to deal with the latest revised most key regulation, Catalogue for the Guidance of Foreign Investment Industries, which determines the license of industrial access for foreign companies and investors entry into the Chinese lucrative market and low cost manufacturing base.

Guidebook Series for Investing in C.....

Invest in China: A Guidebook for Application and Approval of Establishment Registration for Foreign Investment Enterprises The Invest in China Guidebook Series (1) (Second Edition)

$2,000.00
By:
, Published: Apr-2012

Access China Management Consulting Ltd has worked hard to the second edition of the Guidebook Series for Investing in China in order to deal with the latest revised most key regulation, Catalogue for the Guidance of Foreign Investment Industries, which determines the license of industrial access for foreign companies and investors entry into the Chinese lucrative market and low cost manufacturing base.

Invest in China: A Guidebook for Ap.....

Collection of Chinese Laws and Administrative Regulations for Application and Approval of Establishment Registration for Foreign Investment Enterprises The Invest in China Guidebook Series (2) (Second Edition)

$2,000.00
By:
, Published: Apr-2012

Access China Management Consulting Ltd has worked hard to the second edition of the Guidebook Series for Investing in China in order to deal with the latest revised most key regulation, Catalogue for the Guidance of Foreign Investment Industries, which determines the license of industrial access for foreign companies and investors entry into the Chinese lucrative market and low cost manufacturing base.

Collection of Chinese Laws and Admi.....

Invest in China: A Guidebook for Application and Approval of Foreign Investment Projects and Business Scope The Invest in China Guidebook Series (3) (Second Edition)

$2,000.00
By:
, Published: Apr-2012

Access China Management Consulting Ltd has worked hard to the second edition of the Guidebook Series for Investing in China in order to deal with the latest revised most key regulation, Catalogue for the Guidance of Foreign Investment Industries, which determines the license of industrial access for foreign companies and investors entry into the Chinese lucrative market and low cost manufacturing base.

Invest in China: A Guidebook for Ap.....