Chinese guidebook for Adverse Drug Reaction Reporting and Monitoring Regulations

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Chinese guidebook for Adverse Drug Reaction
Reporting and Monitoring Regulations
One-Stop Shop for Business Information
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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. 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.
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The Chinese healthcare market will attract more
and more overseas pharmaceutical manufacturers
and producers to penetrate such market. However,
when searching on website of the Chinese
regulatory authority of drugs, China Food and
Drug Administration, you may find there are many
announcements of adverse drug reaction reports
for those that drugs made by overseas and
multinational pharmaceutical manufacturers. 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?
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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.
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Chinese guidebook for Adverse Drug Reaction
Reporting and Monitoring Regulations (2014) is an
essential resource for overseas and multinational
pharmaceutical manufacturers and producers to
handle an adverse drug reaction reporting
smoothly in China, which provides a detailed
guidance of comprehensive and thorough knowledge
of the Chinese adverse drug reaction reporting
and monitoring regulations. Chinese guidebook
for Medical Device Adverse Event Reporting and
Monitoring is an essential resource for overseas
and multinational medical device manufacturers
and producers to handle a medical device adverse
event reporting smoothly in China, which provides
a detailed guidance of comprehensive and thorough
knowledge of the Chinese medical device adverse
event reporting and monitoring regulations.
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The organizations of this guidebook are arranged
as follows. Chapter 2 provides the general
regulations for medical device adverse event
reporting and monitoring, which cover the
definitions and reporters relating to medical
device adverse event reporting and the special
regulations for medical device adverse event
reporting of overseas manufacturer for imported
medical devices. Chapter 3 introduces the
detailed manufacturers duty for medical device
adverse event reporting, from the
responsibilities and obligations, main monitoring
systems and operation procedures, medical device
adverse event reporting, archives of adverse
event monitoring required by
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the Chinese regulatory authorities for medical
device monitoring to an entire process of medical
device adverse event reporting for manufacturer,
which is important for agents within the
territory of China designated by overseas and
multinational medical device manufacturers,
because they must be in compliance with these
regulations. Chapter 4 addresses the
distributors duty for medical device adverse
event reporting, also from the responsibilities
and obligations, main monitoring systems and
operation procedures, medical device adverse
event reporting, archives of adverse event
monitoring to an entire process of medical device
adverse event reporting for distributor,
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which is important for the distributors within
the territory of China of overseas and
multinational manufacturers of imported medical
devices, because they must be in compliance with
these regulations. Chapter 5 elaborates the user
facilitys duty for medical device adverse event
reporting. Chapter 6 provides a brief
introduction of citizens, legal persons and other
social organizations right for medical device
adverse event reporting.
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Table of Contents

1. Introduction
2. General Regulations for Adverse Reaction
   Reporting and Monitoring
3. An Overview of Chinese Monitoring Network for
   Adverse Drug Reaction Reporting
4. Manufacturers Duty for Adverse Drug Reaction
   Reporting
5. Distributors Duty for Adverse Drug Reaction
   Reporting
6. Medical Institutions Duty for Adverse Drug
   Reaction Reporting
7. Citizens, Legal Persons and other Social
   Organizations Right for Adverse Drug Reaction
   Reporting
8. Information Disclosure and Feedback
9. Legal Liabilities

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