1. Market Research
  2. > Pharmaceutical
  3. > Drug Discovery and Development Market Trends
  4. > Latest Guidebook for Conducting Pharma Clinical Trials in China:From Regulations to Practice(2014 Edition)

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

  • July 2014
  • -
  • Access China Management Consulting Ltd.
  • -
  • 172 pages

Summary

Table of Contents

Executive 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 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. 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.

The organizations of this guidebook are arranged as follows. Chapter 2 provides an overview of the Chinese applicable laws and regulations for drug clinical trials. Chapter 3 introduced an overview of Chinese regulatory authorities for drug clinical trials to give the direction of gateway for clinical trials of imported drugs. Chapter 4 elaborated the definitions of some basic terms used in application and approval process of 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). Chapter 5 introduced the general regulations on application and approval for clinical trials of imported drug registration. Chapter 6 introduced the every party’s responsibilities in clinical trials for imported drug registration. Chapter 7 delineated an entrie process of application and approval procedures for clinical trials of imported drug registration. Chapter 8 provided the full text in English of “Drug Registration Application Form for Imported Drug” to guide you fill it step by step. Chapter 9 gave 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.

Chapter 10 provided 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. Chapter 11 introduced 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 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. Chapter 12 Appendices provided the full text in English of “Drug Administration Law of the People’s Republic of China”, “Regulations for Implementation of the Drug Administration Law of the People’s Republic of China” and “The Chinese Good Clinical Practice of Pharmaceutical Products”.

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.

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.
- 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.

Who should buy this report?
- 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.

Get Industry Insights. Simply.

  • Latest reports & slideshows with insights from top research analysts
  • 60 Million searchable statistics with tables, figures & datasets
  • More than 25,000 trusted sources
Get This Report
24/7 Customer Support

Talk to Ahmad

+1 718 618 4302

Purchase Reports From Reputable Market Research Publishers
Opportunity in Clinical Trials Market in India - 2017

Opportunity in Clinical Trials Market in India - 2017

  • $ 4500
  • Industry report
  • March 2017
  • by Feedback Business Consulting

This report provides insight into the current market scenario, structure and practices. In depth market scenario includes: - Current market size estimate - Revenues by players - Top 5 Companies - Market ...

Global Clinical Trial Management System Growth, Trends and Forecasts (2017 - 2022)

Global Clinical Trial Management System Growth, Trends and Forecasts (2017 - 2022)

  • $ 4250
  • Industry report
  • February 2017
  • by Mordor Intelligence LLP

The Global market for Clinical Trial Management System is expected to reach $2 billion by the end of 2020 growing at a CAGR of around 12.5% from 2014 to 2021. Clinical Trial Management System is a system ...

Global Clinical Trials Market Growth, Trends and Forecasts (2017 - 2022)

Global Clinical Trials Market Growth, Trends and Forecasts (2017 - 2022)

  • $ 4250
  • Industry report
  • January 2017
  • by Mordor Intelligence LLP

The global clinical trials market has been estimated to reach USD 14.2 billion in 2016 and is projected to reach around USD 22 billion by the year 2021, growing at a CAGR (compounded annual growth rate) ...


ref:plp2014

Reportlinker.com © Copyright 2017. All rights reserved.

ReportLinker simplifies how Analysts and Decision Makers get industry data for their business.