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14 Item(s)

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  1. Latest Guidebook for Chinese In-vitro Diagnostic Reagent GMP Regulations

    By: Access China Management Consulting Ltd
    , Published: Nov-2015
    , Product code: ACMC201511006
    China has an indispensable in-vitro diagnostic reagent market for overseas and multinational in-vitro diagnostic reagent companies. Chinese healthcare market has maintained annually average growth rate above 16 % since 1990s. Among them, in-vitro diagnostic reagents represented dynamical growth since 2007. By 2014, total value of in-vitro diagnostic reagents on Chinese healthcare market has reached 4.3 billion US dollars. The in-vitro diagnostic reagents have been widely used in the process of disease prevention, diagnosis, treatment monitoring, prognosis observation, health status evaluation and inherited disease prediction. On the Chinese in-vitro diagnostic reagent market, imported overseas in-vitro diagnostic reagents made by overseas and multinational in-vitro diagnostic reagent manufacturers accounted for about a half, in which the high-tech and high-valued in-vitro diagnostic reagents are almost monopolized by the American Life Technologies, Roche, Abbott, Siemens, Beja Asian capital and other overseas and multinational companies. It is estimated that Chinese in-vitro diagnostic reagent market is likely to be more than 5.68 billion US dollars until 2015, and it is one of segment market of the most growth potentiality.
    $750.00

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

    By: Access China Management Consulting Ltd
    , Published: May-2015
    , Product code: ACMC201505008
    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.
    $750.00

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

    By: Access China Management Consulting Ltd
    , Published: Mar-2015
    , Product code: ACMC201503008
    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. The guidance provides an opportunity to reduce risk from the examination uncertainty and approval delays to eat up your time and energy to achieve a successful entry into such a lucrative drug market, and to avoid trouble for your business smoothly in China. The overseas and multinational pharmaceutical manufacturers must be compliance with the latest regulations.
    $1,495.00

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

    By: Access China Management Consulting Ltd
    , Published: Aug-2014
    , Product code: ACMC 201408003
    An overview of the Chinese applicable laws and regulations for drug clinical trials.
    $1,495.00

  5. Latest Guidebook for Conducting Medical Device Clinical Trials in China: From Regulations to Practices (2014 Edition)

    By: Access China Management Consulting Ltd
    , Published: Aug-2014
    , Product code: ACMC201408004
    Latest Guidebook for Conducting Medical Device Clinical Trials in China: From Regulations to Practices (2014 Edition) guide overseas and multinational medical device manufacturers and their senior executive officers engaging in regulatory affairs to use the Chinese trial venues to keep medical device development lean and achieve a successful approval for their products entry into the Chinese medical device market, from a comprehensive and thorough knowledge of the latest Chinese laws and regulations on clinical trials for imported medical device registration to the practical operation how to comply with the Chinese GCP .
    $750.00

  6. Latest guidebook for Chinese Drug Recall Regulations (2014 Edition)

    By: Access China Management Consulting Ltd
    , Published: Mar-2014
    , Product code: ACMC201403003-
    How to handle a drug recall smoothly in China? When is recall reporting voluntary vs. mandatory? What characteristics of the recall must you consider when making that determination? How to comply with Chinese drug recall regulations? The overseas and multinational pharmaceutical manufacturers and their senior executive officers engaging in regulatory affairs need a comprehensive and thorough knowledge of the Chinese regulations on drug recall. Otherwise the overseas and multinational pharmaceutical manufacturers and their imported drug into the Chinese mainland will lose a lucrative drug market. The regulations on drug recall between China and US-EU are different. Moreover, 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.
    $750.00

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

    By: Access China Management Consulting Ltd
    , Published: Mar-2014
    , Product code: ACMC201403002-
    How to report an adverse drug reaction and event to the Chinese regulatory authorities? Who should report adverse drug reaction and event to the Chinese regulatory authorities? How the Chinese regulatory authorities to monitor the adverse drug reaction and event reporting? How to comply with Chinese regulations for adverse drug reaction reporting and monitoring? A series of questions are facing overseas and multinational pharmaceutical manufacturers. The overseas and multinational pharmaceutical manufacturers and their senior executive officers engaging in regulatory affairs need a comprehensive and thorough knowledge of the Chinese regulations for adverse drug reaction reporting and monitoring. The regulations on adverse drug reaction reporting and monitoring between China and US-EU are different. Moreover, 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.
    $750.00

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

    By: Access China Management Consulting Ltd
    , Published: Feb-2014
    , Product code: ACMC20140203-
    How to report adverse events to the Chinese regulatory authorities? Who should report adverse events to the Chinese regulatory authorities? How the Chinese regulatory authorities to monitor the medical device adverse event reporting? How to comply with Chinese regulations for medical device adverse events reporting and monitoring? A series of questions are facing overseas and multinational medical device manufacturers. The overseas and multinational medical device manufacturers and their senior executive officers engaging in regulatory affairs need a comprehensive and thorough knowledge of the Chinese regulations for medical device adverse event reporting and monitoring. The regulations on medical device adverse event reporting and monitoring between China and US-EU are different. Moreover, the cultural difference between China and Western countries as well as the language barriers will increase the challenge faced by overseas and multinational medical device manufacturers and producers.
    $750.00

  9. Latest Guide to Chinese Pharmaceutical GMP Regulations (2013 Edition)

    By: Access China Management Consulting Ltd
    , Published: Jul-2013
    , Product code: ACMC 201307001-
    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 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 1450 billion RMB 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.
    $750.00

  10. China Pharmaceutical Guidebook: (2013 Edition) Latest Chinese Regulations for Imported Drug Registration

    By: Access China Management Consulting Ltd
    , Published: Jun-2013
    , Product code: ACMC 201306001-
    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 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 1450 billion RMB 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.
    $1,495.00

14 Item(s)

Page 1 of 2