Publications/ China and Hong Kong
| Published by Drug Delivery Technology |
April 2008 |
| By Ames Gross and John Minot |
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| For pharmaceutical companies in China, today is a very exciting time, but also a highly challenging one. Thanks to a rapidly rising economy (GDP growing over 11% in 2006) and newly prosperous citizens wanting better healthcare, the pharmaceutical market there is growing quickly, at about 15% per year. In 2010, some experts predict that China will be the fifth-largest drug market in the world.
However, due to demographic and regulatory changes, the market’s structure and incentives are shifting rapidly. Some Chinese drug manufacturers are going out of business, while others are changing just to survive. Foreign drug companies continue to have many market advantages for their high-end products, but they will also need to move rapidly to keep this position. |
| Published by Pacific Bridge Medical |
April 2008 |
| By Ames Gross and John Minot |
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| China Pharmaceutical Regulatory Report 2008 is a comprehensive report covering all aspects of Chinese regulations on pharmaceuticals. Included is a brief overview of the medical and healthcare industry in China, as well as a listing of all the relevant laws and regulations that govern the testing, registration, manufacture, import, marketing, sale of pharmaceutic al products. Specific topics include: product registration, pricing and reimbursement, importation, orphan drugs, ICH compliance, and intellectual property protection. In addition, this report provides translations of about ten of the latest key pharmaceutical regulations in China. |
| Presented in Pacific Bridge Medical Webcast |
March 2008 |
| By Pacific Bridge Medical |
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| China’s medical device market has grown to $6 billion, the second largest in Asia after Japan. From 2004 to 2005, the number of device manufacturers grew by thousands. However, 2007 saw many quality control problems with recalls and scandals. To be successful in this fast growing market, attend this webcast to learn more about China's current medical device market and its newest regulations. |
| Published by Pacific Bridge Medical |
2008 |
| By Ames Gross and John Minot |
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| China’s pharmaceutical market is not only large and growing quickly – at almost 20% in 2007 – in the near future, it will also join the world’s biggest pharmaceutical markets. This makes it strategically crucial for Western pharmaceutical companies to succeed there. However, the Chinese drug market has unique characteristics which must be understood to make the China potential a reality. |
| Presented in Pacific Bridge Medical Webcast |
March 2007 |
| By Pacific Bridge Medical |
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| Do you know what it takes to succeed in today's ever evolving China pharmaceutical market? What are profitable foreign and domestic drug companies doing in China to maximize growth and increase sales? What are the current market trends and how can you apply these effectively for your company? China is the ninth largest pharmaceutical market in the world, worth approximately $20 billion. Buy a webcast CD today, before it's too late, to learn more about marketing and selling effectively and developing your high-return business strategy. |
| Presented in Pacific Bridge Medical Webcast |
October 2007 |
| By Pacific Bridge Medical |
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| The recent crackdown by the SFDA has meant new regulations and stricter enforcement for all aspects of the Chinese medical device market. Make sure you know of all the recent regulatory changes in China and the SFDA’s plan for the future. This webcast CD will cover dossier preparation and product registration processes in addition to recent new Chinese medical device regulations. |
| Published by MX |
November/December 2007 |
| By Ames Gross and John Minot |
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| The People's Republic of China has become the foremost manufacturing center in the world today. Chinese manufacturing output increased from 4% of the global total in 1995 to 10% in 2006. Over the past 15 years, gross domestic product has grown at about 9% per year. With Western companies continuing to flock to China to source or manufacture products, the country is permanently altering the economic landscape. |
| Presented in Pacific Bridge Medical Webcast |
March 2007 |
| By Pacific Bridge Medical |
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| China’s pharmaceutical market is currently ninth largest worldwide and worth approximately $20 billion. With analysts predicting this market to be fifth largest by 2010, one cannot ignore China’s potential. This webcast will provide an overview of drug registration in China as well as discuss the most recent regulatory issues of the Chinese State Food and Drug Administration (SFDA). |
| Published by Pacific Bridge Medical |
April 2007 |
| By Ames Gross and John Minot |
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| China Pharmaceutical Regulatory Report 2007 is a comprehensive report covering all aspects of Chinese regulations on pharmaceuticals. Included is a brief overview of the medical and healthcare industry in China, as well as a listing of all the relevant laws and regulations that govern the testing, registration, manufacture, import, marketing, sale of pharmaceutic al products. Specific topics include: product registration, pricing and reimbursement, importation, orphan drugs, ICH compliance, and intellectual property protection. In addition, this report provides translations of about ten of the latest key pharmaceutical regulations in China. |
| Presented in Specialty Pharma |
January/February 2007 |
| By Ames Gross and Momoko Hirose |
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| China is the fastest growing economy in the world today. In 2004, GDP in China grew by 9%, while in 2005 it grew by 9.8%. Analysts predict that China’s economy will continue to grow at 8% to 9% per annum through 2010. China’s pharmaceutical market is currently the ninth largest worldwide and worth approximately $20 billion. Analysts forecast that China’s pharmaceutical market will become the fifth largest in the world by 2010, with the OTC market growing to be the largest in the world within ten years. This article describes the requirements for drug registration, in addition to new regulations and other opportunities for medical companies interested in China. |
| Published in Medical Device & Diagnostic Industry |
January 2007 |
| By Ames Gross and John Minot |
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| China’s economy is growing rapidly, and so are standards of production. As its manufacturers continue to develop more sophisticated processes and products, quality standards are increasing dramatically. Medical devices are no exception. China’s medical device market has grown to $6 billion, the second largest in Asia after Japan. From 2004 to 2005, the number of device manufacturers grew by thousands. Capacity is growing both for exporting abroad and manufacturing for China’s domestic market. More standards, national and industrial, are becoming required. While these standards help Chinese sources achieve higher degrees of quality and standardization, they can also present pitfalls. This article briefly describes device GMP and QA regulations and practices in China, as well as recent and coming changes to the system. |
| Presented in Pacific Bridge Medical Webcast |
October 2006 |
| By Pacific Bridge Medical |
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| This webcast provides an overview of China's current Quality Certification systems, Good Manufacturing Practices, and Vigilance, as well as discuss the most recent regulatory issues. Topics covered include new SFDA regulations, supervision inspections, penalities for non-compliance, and quality system audits. |
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| Published
in Medical Device & Diagnostic Industry |
September/October 2006 |
| By Ames Gross and Nancy Loh |
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| The Asian economy has experienced tremendous
GDP growth over the past decade, and is expected to continue at a healthy
pace for the next several years. In particular, the medical device market
has been growing quite rapidly. More and more companies are going to Asia
to sell and manufacture their medical devices. In addition, Asian governments
are developing new or more rigorous regulatory regimes to raise the quality
of medical devices in their countries to international standards. This
article highlights some of the recent regulatory developments for medical
devices in China and Japan. |
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| Presented in OMTEC 2006 |
June 2006 |
| By Ames Gross |
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| Sourcing Medical Devices from China discusses how companies
can successfully source medical devices from China. This presentation includes
discussion of key steps in the sourcing process, including establishing
initial communications, due diligence, contract negotiations and important
contract terms to include when transferring technology, market research,
choosing the right distributor, and important cultural considerations when
doing business with the Chinese. Also included is brief overview information
of the Asian medical device and orthopedic markets. |
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| Presented in Nashville Healthcare
Council |
June 2006 |
| By Ames Gross |
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| Opportunities in the Chinese Medical
Markets includes a brief overview of the medical markets in China. It also
includes discussion of several examples of foreign health services and
hospital companies that are operating in China, as well as new policies
for Taiwanese doctors and investors operating in China. This presentation
also discusses some important points to consider when doing business in
China, including marketing your product, choosing a distributor, and successful
contract manufacturing in China. |
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| Presented
in Pacific Bridge Medical Webcast |
February
2006 |
| By Pacific Bridge
Medical |
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This
webcast provides an overview of the medical device regulations
of the Chinese State Food and Drug Administration (SFDA) as well
as discuss the most recent regulatory issues. Topics covered
include a number of new SFDA regulations, pitfalls
to avoid, and strategies for a successful product registration.
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| Presented at Canadian Association
for Pharmacy Distribution Management Annual Conference 2005 |
May 2005 |
| By Ames Gross |
| As
China and India continue to improve their pharmaceutical regulatory environments
through the implementation of new and stricter regulations, an increased
number of foreign companies are entering these markets. This presentation
provides information on sourcing medical products in China and India, including
how to identify product manufactures, communication issues, pricing, contract
negotiations and due diligence. Outsourcing strategies are also described,
such as outsourcing clinical trials and R&D, and numerous company examples
are given. This presentation also reviews the various types of business
structure options in China and India, such as a representative office,
branch office, and joint venture. |
| |
| Presented at AdvaMed |
April 2005 |
| By Ames Gross |
| China’s
rapidly growing medical market is attracting more and more U.S. companies.
This presentation provides information on distributor searches, contract
manufacturing, and establishing offices in China. Strategies are provided
to help identify, communicate with, and secure contracts with manufacturers
in China. Types of Chinese business structures, including equity joint
ventures (EJVs), cooperative joint ventures (CJVs), and wholly foreign-owned
enterprises (WFOEs), are described, as well as basic recruiting trends
and strategies. Finally, Chinese cultural issues and considerations are
introduced in order to aid U.S. companies in their Chinese business dealings. |
| |
| Published by Pacific Bridge Medical |
March 2005 |
| By Ames Gross and Rachel Weintraub |
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| One of the fastest
growing economies in the world today is China, growing at a rate of around
9 percent per year. The country’s medical device market is currently
worth approximately $3.5 billion. Following China’s entry into
the World Trade Organization (WTO), the State Food and Drug Administration
(SFDA) is making greater efforts to create a better medical device regulatory
environment. In August 2004, the SFDA implemented new registration requirements,
simplifying the device application and review process. Moreover, exporting
to China is becoming easier for foreign companies, and tariffs on most
medical devices have been reduced to less than four percent as of January
2005. The US is the leading exporter of medical devices to China, contributing
nearly one-third of all China’s foreign imports. |
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| Published by Pacific Bridge Medical |
February 2005 |
| By Ames Gross |
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| The Chinese medical device
market is currently worth about $2.5 billion and it is growing rapidly.
Exporting to China is becoming easier and tariffs on most medical devices
have been reduced to 3.9% as of January 1, 2005. The U.S. is the leading
exporter of medical devices to China, with U.S. products making up 1/3
of all imports. Despite relaxed restrictions, there remain many
difficulties in exporting medical devices to China. Local procurement
policies, test requirements, protection of intellectual property, restrictions
on the types of business activities foreign firms can engage in and complex
product registration processes all present potential hurdles to medical
device exporters. |
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| Published in Medical Device
& Diagnotics Industry |
January 2005 |
| By Ames Gross and Loren
Heinold |
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| Outsourcing medical device manufacturing
to China has become increasingly attractive in the last several years.
China was once seen as an option for producing only relatively simple
medical products. Yet, significant improvements in Chinese manufacturers’
sophistication, technology, and—most importantly—product quality
have made China much more popular for medical device OEMs. But popularity
does not always guarantee an easy process. Finding the right factory can
be challenging. There are eight steps that should be part of any medical
device outsourcing project for China. |
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| Presented at RAPS 2004 Annual Conference |
October 2004 |
| By Ames Gross |
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| With a steady increase in foreign trade over the past twenty
years and entry into the World Trade Organization, China offers many new
opportunities for medical product companies. This article provides incite
for foreign companies entering China’s medical product market, including
information on finding distributors in China. Several options for Chinese
distributors are available: Chinese state-owned distribution companies,
namely foreign trading companies (FTC) and industrial trading companies
(ITC), privately owned trading companies, and Hong Kong distributors. Additionally,
information on foreign investment enterprises (FIE), including Equity Joint
Ventures (EJV), Contractual Joint Ventures (CJV), and Wholly Foreign-Owned
Enterprises (WFOE) is provided. |
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| Published in MedPro
Month |
August 2000 |
| By Ames Gross |
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| Once severely restrictive in practice
and economically limited, markets in China are beginning to hold brighter
prospects for successful entry by foreign manufacturers and suppliers.
Medical product companies looking for product import, distribution and
manufacturing opportunities in China will find promise in recent trends
including a growing economy, a rising middle class with growing per capita
incomes, an increased awareness of the benefits of better healthcare,
and China’s entry into the World Trade Organization (WTO). Through
the discussion of the available business strategies, this article will
assist medical product companies in addressing new opportunities in an
ancient land. |
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| Published in Medical Data International |
July 2000 |
| By Ames Gross |
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| Currently, China’s medical device market is worth about
$1.4 billion. As this market continues to grow, more and more foreign medical
device companies will look for ways to expand into China. This article
discusses business strategies available to these companies setting up or
expanding business in China. First, a company should develop a market entry
strategy, based on factors such as the demand for the product, future growth,
and the time frame to enter the market. Distribution options differ, depending
on whether a foreign medical company exports to China, or manufactures
devices in China. When exporting to China, a company may choose between
the following three options: a China state-owned distribution company,
a privately owned trading company, or a Hong Kong distributor. Foreign
companies that manufacture in China may use a Foreign Investment Enterprise,
including Equity Joint Ventures, Contractual Joint Ventures, and Wholly
Owned Foreign Enterprises. Moreover, China’s entry into the WTO and
the related changes taking place, will also help foreign medical companies
establish and expand their businesses in China. |
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| Published by Pacific Bridge Medical |
April 2000 |
| By Ames Gross |
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| China’s pharmaceutical market is the second largest
in Asia, worth $22.5 billion, and will likely increase upon China’s
entrance into the WTO. In March 1998, the Chinese government created the
State Drug Administration (SDA) to oversee drug importation, improving
the enforcement and inspection processes of pharmaceuticals. Since its
formation, the SDA has revised several drug importation regulations, including
the procedures for obtaining a drug import approval, applying for an import
drug license, and making changes to an import license. |
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| Published by Pacific Bridge Medical |
2000 |
| By Ames Gross and Caroline Tran |
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| China’s medical device market is one of the largest
in the world, and with China’s accession to the WTO, foreign medical
companies have an even greater opportunity to enter this fast-expanding
market. As people in China continue to demand better healthcare, the need
for advanced medical equipment is growing. This article offers information
on entering China’s medical device market, including an example of
FONAR Corporation’s (Melville, NY) expansion into this market. Moreover,
distribution options are described for companies interested in exporting
to China or manufacturing in China. Distribution through Foreign Trading
Companies, Industrial Trading Companies, and Foreign Investment Enterprises
is discussed. |
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| Published by Pacific Bridge Medical |
November 1999 |
| By Ames Gross |
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| China’s pharmaceutical market is booming, and with
the formation of the State Drug Administration (SDA) in 1998, enforcement
of pharmaceutical regulations has greatly improved. An increase in drug
supervision, through stricter punishments for drug research, declaration
and registration violations, was implemented by the State Administration
for the Supervision and Management of Medicine. In 1999, the Chinese government
revised its GMP standards, to improve pharmaceutical production and quality.
In addition, this article provides updated information on pharmaceutical
patents, over-the-counter and prescription drug classification, insurance,
healthcare, and pricing. |
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| Published by Pacific Bridge Medical |
December 1998 |
| By Ames Gross |
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| With an average growth rate of about 18%-20% per year, China’s
pharmaceutical market is expected to be the world’s largest market
by the year 2020. Despite complexities within the Chinese system, including
confusion over monitoring and approving certain drugs, and restructuring
of provincial and local level pharmaceutical regulatory systems, foreign
pharmaceutical companies have great investment opportunities. The Chinese
government is working on many market reforms to improve the system. Previously,
China’s Bureau of Drug Policy and Administration (BDPA) and the State
Pharmaceutical Administration of China (SPAC) were both responsible for
the majority of regulatory processes. However, the newly created State
Drug Administration (SDA) is now responsible for regulatory procedures,
eliminating functional overlap and confusion. This article discusses the
additional regulatory changes made by the Chinese government, including
pricing and reimbursement, classification, registration, clinical testing,
and intellectual property rights. |
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| Published by Pacific Bridge Medical |
September 1998 |
| By Ames Gross |
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| As China’s standards of living steadily improves
and healthcare access progresses, foreign manufacturers will have ample
opportunities to invest in China’s growing medical device market.
Recent regulatory reforms and market adjustments have greatly improved
the medical device regulation procedures. This article highlights the
changes in the regulatory processes, including product registration
of imported and domestic devices, penalties for violating regulations,
product testing requirements, quality system inspection, intellectual
property protection and marketing regulations. China’s medical
device market holds tremendous investment opportunities for foreign
device manufacturers as long as foreign companies monitor regulatory
changes |
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| Published by Pacific Bridge Medical |
1995 |
| By Ames Gross |
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| There are a myriad of opportunities for foreign companies
looking to invest into China, whether in electronics, energy, medical
products, telecommunications or various other sectors. This article
provides comprehensive information on the variety of methods in which
a foreign company can penetrate the Chinese market. First, a foreign
company can export products to China via a Hong Kong distributor, which
can be quick and easy but may not allow full market penetration. Second,
a company can enter the market via a direct channel in China. This
method is time consuming but will allow fuller market penetration.
Lastly, market entry via a joint venture may be the best option for
both parties-Chinese and Western-by allowing full market penetration
and control by both parties. Each market entry strategy yields advantages
and disadvantages, and each strategy’s success will depend on
the demand for the firm’s product. |
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| Published in BioPharm |
January/February 1995 |
| By Ames Gross |
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| The Chinese biotech industry is becoming one of Beijing’s
priorities, as biotechnology becomes one of the world’s most
dynamic and essential modern technologies. Four types of institutions
in China already engage in biotechnology research including Academia
Sinica (a think tank), university institutes, medical schools, and
specialized production facilities. Additionally, Beijing has implemented
the 863 Plan (National High-Tech Research and Development Program)
to concentrate specifically on high-tech medicines and vaccines, protein
engineering, and gene therapy. As the biotech market in China expands,
the government will rely heavily on international imports, technological
expertise, and collaboration on research development from Western biotech
companies. As a result, foreign companies have ample opportunities
to invest in China’s quickly growing market. This article provides
advice for foreign companies seeking opportunities to penetrate China’s
biotech market. Also included is an appendix of Chinese foreign investment
enterprises. |
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| Published in Medical Industry
Executive., a publication of Medical Industry Publication |
April/May 1994 |
| By Ames Gross |
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| As China becomes the fastest growing economy in the world’s
fastest growing region, foreign manufacturers are eager to take advantage
of China’s quickly expanding markets, particularly the medical
market. Whether a company decides to enter the market through a Hong
Kong distributor, a direct channel in China, or through a Foreign Investment
Enterprise (FIE-joint venture), each opportunity offers pluses and
minuses. This article serves as a guide for foreign medical device
manufacturers who are looking to invest in the dynamic Chinese medical
market. Additionally, lists of co-production agreements in China, existing
manufacturing medical device joint ventures, different types of Chinese
FIEs, and statistics of medical device imports are also mentioned. |
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| Published in Clinica, a publication
of PJB Publication, Ltd. |
November 1993 |
| By Ames Gross |
|
| Although China’s healthcare system is run by the
central government, its slow decentralization is prompting a multitude
of changes. Chinese consumers have growing incomes and are looking
for more advanced treatments, sometimes preferring Western-style treatments
over Chinese traditional medicine. Additionally, hospitals are now
able to make independent decisions regarding medical equipment and
modern technologies to accommodate the growing demand for modern treatment.
However, as the cost of treatment goes up, the uninsured population,
over 800 million people, only receive the treatment that they can afford.
This article examines the basic features of China’s complex healthcare
system. Western companies should understand the Chinese healthcare
system before investing in this quickly expanding market. |
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| Published in Clinica,
a publication of PJB Publication, Ltd. |
October 1993 |
| By Ames Gross |
|
| Hong Kong’s large open market economy has been
encouraging foreign trade for decades, including the importation of
medical devices. The U.S., Japan, China and Germany are all leading
exporters in Hong Kong’s medical device market and the market
is already worth well over $342 million, with expectations to increase.
This article discusses the tremendous opportunities for foreign medical
device suppliers in the Hong Kong medical market. The article includes
information about the basic functions of the Hong Kong healthcare system,
including the role of the Hospital Authority and the Government Supplies
Department (GSD). Additionally, information regarding the future prospects
of diagnostic equipment is mentioned, as there are no domestic producers
in Hong Kong. Furthermore, increasingly high incomes in Hong Kong mean
more spending on healthcare by its citizens and the government, which
will provide abundant opportunities for success for foreign medical
manufacturers. |
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| Published in Clinica,
a publication of PJB Publication, Ltd. |
April 1993 |
| By Ames Gross |
|
| This article is a general overview of the many opportunities
available for foreign device manufacturers interested in entering China’s
medical device market. Key topics include the current healthcare system
and its basic features, market entry strategies and business relationships
in China. Although Western medical imports have been limited in the
past, increasing economic growth and more affluent patients are leading
to a greater demand in improved healthcare and modern foreign medical
technology. As a result, medical device imports are expected to grow
at least 8% per year, providing huge potential in China’s healthcare
market for foreign manufacturers. |
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