Chinese trials could face more bureaucracy

Law firm Sidley Austin said the China Human Genetic Resources Administration Office (CHGRAO) indicated it should have the authority to approve clinical studies sponsored by foreign companies in China if the studies involve human sample collection. The approvals would include studies sponsored through local CROs and should be in place before clinical study agreements are signed with Chinese hospitals, according to law firm Sidley Austin.

Chen Yang, a partner at Sidley Austin in Beijing, said CHGRAO's new position could potentially extend the review time for clinical trial authorizations (CTAs) in China by six to eight months or longer, since it is unclear whether the office would allow its approval process to be conducted in parallel with China FDA approvals. CFDA requires reproductive toxicology data, CMC data and a sample of the compound and takes 8-10 months to review CTAs. In practice it takes longer, according to companies contacted by BioCentury (see BioCentury, Feb. 25, 2013). ...