Covance says SFDA GLP certification for Shanghai early-phase facility will save sponsors time and money in China and elsewhere.
The contract research organisation (CRO) received good laboratory practices (GLP) accreditation earlier this week for the facility it opened in 2010 as a China hub for non-clinical safety assessment, in vivo pharmacology and bioanalytical and DMPK services.
Covance told Outsourcing-pharma.com that: “The SFDA GLP certification is significant because unlike in the United States, where a facility can claim compliance to GLP without prior inspection, a facility must have been in operation under GLP for at least 12 months and have completed validation studies prior to applying for SFDA inspection and obtaining a certification.
“Without SFDA certification, data generated from the facility will not be accepted by SFDA for regulatory approvals.”
The firm also said that the award – which adds to the accreditation it received from the Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC) Belgian GLP Monitoring Authority in 2011 – will give it an edge over other global CROs operating in China.
"Covance is the only global CRO with SFDA GLP certification in China. With our SFDA GLP certification, our clients can now file an IND in China and other global regulatory authorities based on the one set of GLP studies - a significant advance that will offer time, as well as cost, savings for clients in their drug development projects.”
Competition in China’s preclinical research services is increasing with Covance being only the latest global CRO to be positioning for growth in the country.
Early last month fellow US-based contractor Charles River Laboratories (CRL) bought a controlling stake in Beijing-based Vital River citing an uptick in demand for its research models business from academia, government and biopharmaceutical companies.
Local players are also upping their game. In October Sino-US CRO Pharmaron bagged a discovery services contract with AstraZeneca .
A month prior to that China-based Wuxi PharmaTech partnered with US transgenic animals firm Open Monoclonal Technology (OMT) to boost its antibody discover capabilities.