PharmAsia News: Pharmarama To Source Drugs For Chinese Clinical Trials

SHANGHAI - Pharmarama will begin sourcing pharmaceutical products for comparator clinical trials in China, the company announced Nov. 14 at BIO-Europe 2007 in Hamburg, Germany.

“Pharmarama will source new drugs into China for the purposes of conducting comparator clinical studies and for named patient programs where no suitable alternative product exists,” Pharmarama Spokesperson Scott Solomon told PharmAsia News. “Chinese drug makers will now have the opportunity to use the same drugs which are being used outside of mainland China for comparator clinical studies.” The service is available immediately, he said.

In China, procuring comparator drugs for clinical trials is a regular component of the clinical trial process, though the associated logistics make it a complex and time-consuming process. With increasingly stricter 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, according to the company.

“China is set to be among the top five largest pharmaceutical markets in the world by 2010 and is becoming a major location for clinical trials,” said Angus Cameron, Pharmarama’s director of business development and spearhead of the company’s China operations. “Holding a clinical trial 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.”

“We are continuing to put in place the protocols that ensure compliance with the State Food and Drug Administration’s new drug registration regulations, and can also provide our clients with a complete pedigree on any comparator drug sourced within China for their global trials,” added Cameron.

SFDA implemented the newly revised provisions for drug registration on Oct. 1 (PharmAsia News, July 23, 2007) .

An investigational drug used for an international multi–center clinical study has to be one already registered in a foreign country or in Phase II or Phase III clinical trials, according to the newly revised provisions for drug registration.

“The comparator drug should be one which has already been sold on shelves in the domestic market,” Dermot Zhang, a lawyer in Shanghai-based Haworth & Lexon law firm, told PharmAisa News. “As for the especially imported ones, before being put into clinical trials, prior approvals of SFDA should be obtained, and such drugs should also have passed the quality inspections by the Drug Inspection Authority at the arrival port.”

Clinical trials for pharmaceuticals in China are typically conducted through one or more of the 251 Chinese hospitals licensed by the SFDA. These hospitals have been selected nationwide according to a set of specific criteria and focus on various clinical specialties.

Established in 2006, as the U.S. affiliate of UK-based BR Pharma Ltd., Pharmarama sources and procures pharmaceutical products for clinical trials for international pharmaceutical companies and clinical research organizations.

“Our protocols will ensure trial sponsors and CROs of the total reliability of the comparators chosen, from the manufacturer through to the clinic,” said Cameron. “We also have the procedures and relationships in place to provide Chinese-licensed European comparators into the vast Chinese clinical trial market, through both international multi-center programs, as well as in cooperation with the 251 major hospitals licensed by the SFDA to conduct clinical trials.”

– Dai Jialing (pharmasia@elsevier.com)