MedMira Headquarters Visited by China's State Food and Drug Administration
April 21 2005 - 10:08AM
PR Newswire (US)
MedMira Headquarters Visited by China's State Food and Drug
Administration Only Canadian Company to Receive State Agency Visit
HALIFAX, April 21 /PRNewswire-FirstCall/ -- MedMira Inc.,
("MedMira") (TSX Venture: MIR, NASDAQ: MMIRF) the global market
leader in rapid flow-through diagnostic technology, announced today
that two directors from China's State Food and Drug Administration
(SFDA) recently visited MedMira's corporate offices and
manufacturing facilities in Halifax, Nova Scotia. The directors
were part of an eight-member delegation from the SFDA, invited by
the United States and Canadian regulatory bodies. The SFDA is the
state authority in China governing all drug and medical devices
manufactured by both domestic and foreign companies. The Biological
Division of the SFDA is responsible for review and approval of HIV
testing devices, such as MedMira's currently approved MiraWell(TM)
Rapid HIV Test and the new rapid fingerstick whole blood test,
which is undergoing clinical trials in China. MedMira is the only
Canadian company currently licensed to import rapid HIV tests into
China. "We were pleased to visit MedMira and observe their
high-quality manufacturing facilities," said Dr. Yin Hongjhang,
Director of the Biological Division of the SFDA during his speech
at a dinner reception. "We are thrilled to have gained the
opportunity to view, first-hand, the upcoming products for which
MedMira plans to seek our approval." Dr. Chang Yongheng, Director
of the Product Registration Division of the SFDA, also presented an
updated SFDA approval algorithm for new medical devices at the
reception. "We greatly welcomed this visit from the SFDA delegates
in our Halifax facilities, and are extremely thankful to
representatives from our federal and provincial governments and
business community who joined us to greet our guests," said Stephen
Sham, Chairman and CEO of MedMira. "As we continue to increase our
product portfolio in the China market, we are delighted to see the
interest from these two directors in our newest innovations."
MedMira's MiraWell(TM) Rapid HIV test is currently used by public
health organizations in China's Jilin province, a result of the
first provincial government tender to be awarded to a Canadian
company. It was recently ranked the number one rapid HIV test in
overall performance in a 2004 China National Center for Disease
Control (CDC) report. About MedMira MedMira is the leading global
manufacturer and marketer of in vitro flow-through rapid diagnostic
tests for the clinical laboratory market. MedMira's tests provide
reliable, rapid diagnosis in just 3 minutes for the detection of
human antibodies in human serum, plasma or whole blood for diseases
such as HIV. The United States FDA and the SFDA in the People's
Republic of China have approved MedMira's Reveal(TM) G2 and
MiraWell(TM) Rapid HIV Tests, respectively. MedMira's Reveal(TM) G2
and MiraWell(TM) rapid HIV tests are currently used in clinical
laboratories and hospitals where professional counseling and
patient treatment are immediately available. The MiraCare(TM) Rapid
HIV Antibody Test is available over-the-counter (OTC) in pharmacies
throughout the Hong Kong and Macao Special Administrative Regions,
in the People's Republic of China. MedMira markets its rapid tests
worldwide in such countries as the United States, Canada, South
Africa and China. Its corporate offices and manufacturing
facilities are located in Halifax, Nova Scotia, Canada with a
representative office in Beijing, China. This news release contains
forward-looking statements, which involve risk and uncertainties
and reflect the company's current expectation regarding future
events. Actual events could materially differ from those projected
herein and depend on a number of factors including, but not limited
to, changing market conditions, successful and timely completion of
clinical studies, uncertainties related to the regulatory approval
process, establishment of corporate alliances and other risks
detailed from time to time in the company quarterly filings. The
TSX Venture Exchange has not reviewed and does not accept
responsibility for the adequacy or accuracy of this statement. For
more information visit MedMira's website at
http://www.medmira.com/. DATASOURCE: MedMira Inc. CONTACT: Dr.
James Smith, Investor Relations, Tel: (902) 450-1588, E-mail:
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