Comparator trial procurement firm Pharmarama is to source drugs for clinical trials in China.
Announcing the move at BIO-Europe 2007 in Hamburg, Germany, Pharmarama said it believed that it was 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 five 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.
“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 Administration¹s (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,” Mr Cameron said.
“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 by ethical committees overseas and the program initiators are also from overseas.