Latest Guidebook for Conducting Pharma Clinical Trials in China - From Regulations to Practice (2014 Edition), New Report Launched

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 aging 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. 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 (2014 Edition) 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.

Target Audience:

• Overseas pharmaceutical companies wishing to enter into the Chinese drug market.
• Multinational pharmaceutical companies have penetrated into the Chinese drug market.
• Companies interested in understanding the latest Chinese laws and regulations for pharmaceutical product clinical trials.
• Senior executive officers engaging in regulatory affairs for imported drugs into Chinese lucrative drug market.
• Senior executive officers engaging in conducting clinical trials for imported drugs in China.

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 entire 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.
• The practical guidance for clinical trials of imported biological product registration, also from the general and special regulations on clinical trials for imported biological product registration, the requirements for data and materials of application for approval of clinical trials for imported biological products to the data and materials submission of application for approval of clinical trials for imported biological products to smoothly navigate complex regulatory requirements step by step.
• The practical guidance for clinical trials of imported natural medicine and traditional Chinese medicine registration, again from the general and special regulations on clinical trials for imported natural medicine and traditional Chinese medicine registration, the requirements for data and materials of application for approval of clinical trials for imported natural medicines and traditional Chinese medicines to the data and materials submission of application for approval of clinical trials for imported natural medicines and traditional Chinese medicines to smoothly navigate complex regulatory requirements step by step.
• A set of full text in English of Chinese laws and regulations for pharmaceutical product clinical trials.

Spanning Over 191 pages, “Latest Guidebook for Conducting Pharma Clinical Trials in China: From Regulations to Practice (2014 Edition)” report covering the Chinese Applicable Laws and Regulations for Drug Clinical Trials, An Overview of Chinese Authorities for Drug Clinical Trials, Knowledge Preparation before conducting Imported Drug Clinical Trials, General Regulations on Application and Approval for Clinical Trials of Imported Drug Registration, Every Party’s Responsibilities in Clinical Trials for Imported Drug Registration, Application and Approval Procedures for Clinical Trials of Imported Drug Registration, Application Form for Imported Drug Registration, Practical Guidance for Clinical Trials of Imported Chemical Drug Registration, Practical Guidance for Clinical Trials of Imported Biological Product Registration, Practical Guidance for Clinical Trials of Imported Natural Medicine and Traditional Chinese Medicine Registration, Appendices.

See Table of contents & Purchase this publication at: - http://mrr.cm/Zss