Introducing Pacific Bridge, Inc.

Dear Sir or Madam:

I hope all is well with you.  I am writing this email to introduce myself
and my company.  Pacific Bridge, Inc., (www.pacificbridgemedical.com)
provides consulting services for medical companies (i.e. medical device,
pharmaceutical, bio-tech) seeking to enter and/or increase their penetration
of the Asian marketplace.  Our services include:

1) Product registration and other regulatory matters;
2) Setting up joint ventures / licensing technology;
3) Finding and qualifying distributors / agents to sell medical products;
4) Market research;
5) Sourcing; and
6) Recruiting.

Please contact me if you have any need for these services.

In addition, you may be interested to know that PBI publishes a FREE Asian
Medical eNewsletter.  The eNewsletter, delivered via email once a month,
offers timely, insightful, relevant Asian medical information (regulatory,
market entry strategies, etc.) free of charge to anyone who is interested.

For your perusal, a copy of our eNewsletter is attached to the bottom of
this email.  We hope that you find it valuable and informative.  If you
would like to continue receiving our free eNewsletter, simply hit the reply
button and type, "SUBSCRIBE" in the subject line.  However, if you are not
interested in receiving our free eNewsletter, please hit the reply button
and type "Remove" in the subject line.  Also, please feel free forward this
message to anyone you know who might be interested in our Asian medical
information.  Thank you for your interest in PBI.

Thanks and Best Regards,

Ames Gross
President

Pacific Bridge, Inc.
1155 Connecticut Ave. N.W.
Suite 850
Washington, D.C. 20036
(202) 467-5020 - Phone
(202) 833-2279 - Fax
info@xxxxxxxxxxxxxxxxxxxxxxxx - Email
www.pacificbridgemedical.com - Website

* * * * * * * * * *
PBI ASIAN MEDICAL eNEWSLETTER * Volume 2, Number 12 * March 4, 2003

This Issue:
1. Counterfeit Drugs in China:  Shanghai Steps Up Drug Monitoring Systems
2. Promoting Taiwan's Medical Equipment Market in the International Arena
3. Singapore Launches Standardization for Medical Devices
4. Effects of Genome-Based Medicine on Japanese Medical Regulation


* * * * * * * * * *

COUNTERFEIT DRUGS IN CHINA: SHANGHAI STEPS UP DRUG MONITORING SYSTEMS

In January 2003, the Shanghai Drug Administration Bureau announced its
resolve to tighten controls over pharmaceuticals and drug distribution as
well as create more efficient systems for reporting adverse reactions to
medication.  According to recent reports by the bureau, of 14,980 drugs
inspected in 2002, 1,833 were found to be below quality standards.  China is
also the largest producer of counterfeit drugs in the world.  Some of these
imitation or counterfeit pharmaceuticals are composed of materials that do
not contain proper active ingredients; some are filled with talcum powder or
flour, while others contain toxic materials.

Shanghai will be the first city to implement these tighter controls.  In
many cities, even members of the police act as informants to medical
distributors, alerting them of impending spot checks.  A system is already
in place in Shanghai to prevent pharmacies and drug manufacturers from being
tipped off prior to inspection visits.

Greater efforts will also be made to strengthen the capabilities of the
Shanghai Drug Adverse Reaction Monitoring Center.  The city plans to create
a more effective system of adverse drug reporting and response in order to
protect the safety and health of local residents.   Last year, the center
received 960 calls regarding adverse reactions to medication from local
medical facilities.  This is three times greater than the number of calls
received in 2001.

According to the Shenzhen Evening News, approximately 192,000 Chinese people
have died because of fake drugs.  Since China's accession to the WTO
(December 2001), the Chinese government has made concerted efforts to crack
down on the counterfeit drug industry.  In the first half of 2002, the
government uncovered 70,000 cases of counterfeit drug production; this
figure exceeds the total number of cases uncovered in the whole of 2001.

Director of the Shanghai Drug Administration Bureau, Wang Longxing, stated
"In the year 2003, the bureau will spend more time monitoring the drug
market following the whole process from manufacturing to selling.  Moreover,
we will strengthen the registration system for new medicines and appliances
to control the market."


PROMOTING TAIWAN'S MEDICAL EQUIPMENT MARKET IN THE INTERNATIONAL ARENA

With the help of University of Chicago professor Chin-Tu Chen, Taiwanese
medical equipment makers are determined to strengthen their position in the
international market.  Dr. Chen was invited by Taiwan's National Health
Research Institute (NHRI) to assist in the development of the country's
medical equipment and biomedical instrument industries.  Currently, medical
equipment manufacturers are utilizing two means to establish a foothold in
the international market: 1) through contract production, and 2) by
aggressively promoting Taiwanese own-brand products in developing countries.

Dr. Chen believes that Taiwan's medical equipment market has the most
promise for growth of local companies.  Through utilizing infrastructure
that is currently available, such as industrial infrastructure for
electronics, semiconductors, and telecommunications, Taiwanese companies can
produce medical equipment relatively quickly.  Through the integration of
these infrastructures, local medical manufacturers will be able to win more
contract production business from international companies.

Local medical equipment makers are heeding Dr. Chen's advice by planning a
joint international marketing company to assist them in penetrating emerging
markets.  Among the local companies that will be major investors in this
venture are: Bioteque Corporation, President Life Sciences Company, and Apex
Medical Corporation.  Medical equipment manufacturers recognized the need
for assistance in promoting their products in the international market due
to intense competition particularly from China.  Prospective shareholders of
the marketing venture proposed that the company be initially capitalized at
$575,000.  In order to promote these ventures, the Taiwanese government has
also announced that it would be subsidizing certain international marketing
ventures.  According to the Ministry of Economic Affairs (MOEA), the
government will set aside a budget of $5.2 million for relevant endeavors in
2004.


SINGAPORE LAUNCHES STANDARDIZATION FOR MEDICAL DEVICES

SPRING Singapore (Standards, Productivity and Innovation Board) and the
Economic Development board launched Singapore's first efforts to standardize
the country's medical devices industry on January 17, 2003.  The standard
proposed by the governing authorities is called the Technical Reference for
Medical Device Components, or TR for short.  It is based largely on the US
FDA Quality System Regulations (QSR).  The TR is currently on a two-year
trial and will be open to feedback by the medical device industry before
being fully implemented.  The Singaporean government hopes their initiative
will bring about greater harmonization of quality standards.

The first of the technical references launched this month was the Quality
System for Medical Device Components.  This interim standard was developed
specifically for the biomedical sector in order to cut costs and facilitate
Singapore's scheme to become a biomedical hub.  Lee Suan Hiang, Chief
Executive of SPRING Singapore, stated, "The Technical Reference is expected
to help them [medical device multinationals] save costs, as well as
facilitate audit checks on their quality systems.  At present, the quality
systems used by manufacturers vary and each supplier needs to have its
quality system checked by its customers.  With a common standard, suppliers
can upgrade their capabilities independently, thus reducing the resources
required to meet the different requirements of each customer."

Singapore's medical device industry generates approximately S$1.6 billion
(US$928 million) per year and filled 3,900 jobs in 2001.


EFFECTS OF GENOME-BASED MEDICINE ON JAPANESE MEDICAL REGULATION

The advent of genome-based medicine and pharmacogenomics (the medical field
that analyzes the reasons why people have different reactions to similar
treatment) is expected to transform the medical regulatory environment in
Japan.  As the human genome is decoded, development of new medicines will be
based upon individuals and their unique genetic makeup.  Instead of generic
drugs, designer drugs developed specifically for individuals will become the
norm.  Due to these reasons, the current standards for clinical testing for
new pharmaceutical products will no longer apply.  Instead, testing for the
safety and efficacy of a particular drug product would only need to be done
on specific groups of people for which the drug was designed rather than on
a pool of randomized subjects.  Masatoshi Ishizuka, the Director of the
Research and Development Promotion Department at the Organization for
Pharmaceutical Safety and Research (OPSR) believes that genome-based
research will vastly increase the success rate and shorten the time of
medical product development in Japan.  As a result, costs will be
considerably lowered.

Dr. Stefan Wohlfiel, head of Bayer Yakuhin, Ltd.'s research center in Kyoto
illustrated this quickening in product development as well as lowered costs
when he said, "Our research goal has been to increase yearly CDs [candidate
drugs] from two in 1995 to 20 by 2004.  This entails increasing productivity
by 30% and efficiency by 17% per year while, at the same time, decreasing CD
costs by 75%."

Although changes are expected to occur in Japan's regulatory environment due
to the advances in genome-based medicines, these changes will not occur at a
rapid pace.  Hirotaka Yabuki, Vice President of The Boston Consulting Group
K.K. believes that the approval process that currently averages 14.7 years
"could be reduced by two to three years by a genomics-based approach, such
as industrialization of target identification, pharmacogenetics and
parallelization of the discovery process."  Even though the speed of
regulatory approval may not decrease considerably, the differing quantity
and quality of data will facilitate the job of the regulators significantly.


* * * * * * * * * *

Thank you for reading our eNewsletter!

Pacific Bridge, Inc. provides consulting services to international medical
companies that are looking to expand their presence in Asia.  Questions?
Comments? Email us at AsianMedNewsletter@xxxxxxxxxxxxxxxxxxxxxxxx or visit
our website, www.pacificbridgemedical.com.

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