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 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.
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 drug
recall for those that drugs made by overseas and multinational pharmaceutical
manufacturers.
View summary of this report @ http://www.radiantinsights.com/research/latest-guidebook-for-chinese-drug-recall-regulations-2014-edition
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.
Latest
guidebook for Chinese Drug Recall Regulations (2014 Edition) is an essential
resource for overseas and multinational pharmaceutical manufacturers and
producers to handle a drug recall smoothly in China, which provides a detailed
guidance of comprehensive and thorough knowledge of the Chinese drug recall
regulations.
Download sample Copy of This Report at: http://www.radiantinsights.com/research/latest-guidebook-for-chinese-drug-recall-regulations-2014-edition#tabs-4
Latest
guidebook for Chinese Drug Recall Regulations (2014 Edition) provide highlights
as followings:
An
overview of organizational structure of Chinese regulatory authorities for drug
recall and the complete picture of organizational structure of Chinese
regulatory authorities for drug recall.
The
Chinese general regulations for drug recall, which cover the definitions
relating to drug recall, the answers of who, where and how to submit the report
relating to drug recall, the pharmaceutical manufacturer’s duty for drug
recall, the distributor and user facility’s duty for drug recall, the
investigation and evaluation of drug safety hazards, the classification for
drug recall, as well as the special regulations for overseas manufacturers of
imported drugs.
The
detailed regulations for voluntary recall of drugs, from the time limits of
notifying, the indispensable content of the recall plan and the investigation
and evaluation report, the report of recall program implementation situation to
smoothly navigate complex regulatory requirements step by step for agents
within the territory of China designated by overseas manufacturers of imported
drugs, because they must be in compliance with these regulations.
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An
entire process of voluntary recall of drug.
The
detailed regulations for mandatory recall of drug, which covers how would
trigger a mandatory recall of drug, how the pharmaceutical manufacturer copes
with a mandatory recall of drug, and how to handle a mandatory recall of drug
smoothly in China for agents within the territory of China designated by
overseas manufacturers of imported drugs, because they must be in compliance
with these regulations.
An
entire process of mandatory recall of drug.
The
detailed legal liabilities for the pharmaceutical manufacturer, the
distributors, and the user facilities of drugs for drug recall.
A
case study of drug recall to expose practical operation.
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 the latest Chinese Drug
Recall Regulations. After having skimmed through this guidebook, audiences can
clearly acquire a comprehensive and thorough knowledge of the latest Chinese
Drug Recall Regulations. 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 market, and smoothly operate their
companies in China.
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