Pharmarama, a leader in the procurement of pharmaceutical products for comparator trials and named patient programs, today announced today at BIO-Europe 2007 in Hamburg, Germany, that the firm will be providing complete services to source comparator drugs for clinical trials in China. Pharmarama believes that it is the first global clinical trial supply company to have the necessary relationships and protocols in place to source comparator drugs both into and out of mainland China.
BOREHAMWOOD, U.K. (Business Wire EON) November 14, 2007 --
Pharmarama, a leader in the
procurement of pharmaceutical products for comparator trials and named
patient programs, today announced today at BIO-Europe
2007 in Hamburg, Germany, that the firm will be providing complete
services to source comparator drugs for clinical trials in China. Pharmarama
believes that it is the first global clinical trial supply company to
have the necessary relationships and protocols in place to source
comparator drugs both into and out of mainland China.
“China is set to be among the top 5 largest
pharmaceutical markets in the world by 2010 and is becoming a major
setting for clinical trials,” said Angus
Cameron, Pharmarama’s Director of Business
Development and spearhead of the company’s
China operations. “Holding clinical trials in
China carries the benefit of reducing the time for a drug to reach the
rapidly growing local market, and also presents a large patient pool
important for worldwide drug development at a time when patient
recruitment is becoming increasingly difficult.”
However, procuring comparator drugs for clinical trials in China –
an often-key component of the trial process –
and the management of their associated logistics is a complex,
time-consuming process. Given stringent local regulations and recent
international concerns over the quality and safety of products
manufactured in China, the comparator drug procurement process has
become even more daunting.
“We are continuing to put in place the
protocols to ensure compliance with the State Food and Drug
Administration’s (SFDA) new Drug Registration
Regulation, in effect this October, and can provide our clients with a
complete pedigree on any comparator drug sourced within China for their
global trials,” continued Cameron. “This
will ensure trial sponsors and CROs of the total reliability of the
comparator chosen, from the manufacturer through to the clinic. We also
have the procedures and the relationships established to provide
Chinese-licensed European comparators into the vast Chinese clinical
trial market through both international multi-centre programmes, as well
as in cooperation with the 251 major hospitals licensed by the SFDA to
conduct clinical trials.”
Clinical trials for pharmaceuticals in China are typically conducted
through one or more of the 251 Chinese hospitals licensed by the SFDA.
These hospitals, found throughout China, have been selected according to
a set of specific criteria and are focused on various clinical
specialities. Bringing European licensed drugs into China for a
comparator trial is also possible as part of an international
multi-centre programme, where the protocols have been agreed to by
ethical committees overseas and the program initiators are also from
overseas.
About Pharmarama
Pharmarama is a licensed
wholesaler and importer of licensed and unlicensed medicines, based in
London, England, with offices located in the United States and Germany.
The company, in partnership with BR Pharma, provides validated
comparator drug services such as sourcing, supply chain management and
support services including drug warehousing, custom pharmaceutical
manufacturing, packing and translation services.
Pharmarama was founded in 2006
by Ben Rabin as the U.S. affiliate of UK-based BR
Pharma Limited, which first gained recognition for obtaining
regulatory permission to import Ritalin SR into the U.K. Rabin, a
pharmacist with over 40 years in the retail and wholesale pharmaceutical
industries, and BR Pharma have provided over a decade of service to the
world’s leading pharmaceutical companies and
clinical research organizations sourcing and procuring pharmaceutical
products for clinical trials, as well as providing services for named
patient programs. Pharmarama works in collaboration with BR Pharma as a
single point of contact for the sourcing, repacking, blinding and
distribution of comparator drugs worldwide.
For more information, please visit us on the Web at www.pharmarama.com
or www.brpharmaltd.co.uk.
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