Regulatory Changes Position China as a Global Clinical Trial Destination

Global biopharma companies have long held concerns over China’s slow drug and medical device approval

Philip Gregory

system, with long processing times and rigid intellectual property (IP) restrictions delaying market launch and uptake. Throughout this year, the China Food and Drug Administration (CFDA) has been addressing these issues to adjust evaluation and approval procedures, in an effort to attract advanced foreign drugs to China. The CFDA has also just announced that it will formally join ICH GCP, further strengthening the need for international harmonization of the drug approval process in China.

The challenges for foreign pharma companies in China lie in drug development, optimization and approval, with success being largely dependent on regulatory know-how. Imported drugs are often approved three to six years later than other countries.

In order to address this lag in approval, the CFDA have considered measures to reduce the time to market, in order to ease drug shortages and meet the public demand for affordable medicines. Proposed updates to the CFDA regulations include removing the requirement for global multi-center trials to be in Phase II or III clinical trials for prior foreign approval; and allowing pharma companies to apply directly for market authorization for imported drugs, once clinical trials are complete. The CFDA will also prioritize innovation, to ensure faster approval.

Foreign pharma companies are increasingly opting to follow the Category I pathway (the default for drugs not approved elsewhere) for which the CFDA requires a comprehensive clinical drug development program. An imported drug may be submitted for market approval under Category I, which may result in swifter evaluation and approval.

The increase in drug approvals sought under Category I will result in global multi-center trials with programs in China becoming a key strategy for drug developers. The CFDA’s recent pledge to reduce unreasonable demands and streamline regulatory approval process is a promising development, and will ensure China remains a critical player in the global pharmaceutical market. The key to obtaining faster China approvals will be to conduct quality trials and utilize efficient research networks.

George Clinical is a leading Asia-Pacific contract research organization (CRO), offering high-quality and comprehensive clinical trial research services, underpinned by scientific expertise across a broad range of therapeutic disciplines. With offices in Beijing and Shanghai and operations in 10 other China cities, George Clinical China offers full CRO services across a network of more than 260 trial centers.

Philip Gregory is Managing Director of George Clinical.