China is planning to enact changes that will view the intentional forging of clinical trial and other data submitted to gain drug approvals as a criminal offence, punishable by prison terms of up to three years.
In a document issued April 10, China’s top court, the Supreme People’s Court, has said it is planning to make clinical data forgery and similar violations criminal acts subject to formal legal punishment.
The court listed three categories of behavior that will be considered criminal under the proposed changes:
FDA regulation was painted as an obstacle to US dominance in the cell and gene therapy space even as panelists at an agency event praised the Office of Therapeutic Products' track record under Nicole Verdun.
At this year’s DIA China meeting, the national regulator updated its policy focus areas for this year, including clinical trial data protection and pilot projects to shorten IND approval times.
Legislation prohibiting work with certain Chinese biopharma firms will be reintroduced soon, Democratic Sen. Gary Peters said. And it will not be the only bill tied to international biotech competition and security concerns that will be considered.
As the US FDA expands unannounced foreign inspections building on pilots in India and China, experts expect higher scrutiny of overseas sites and perhaps even an industry shakeout in the longer term, though staffing and enforcement challenges could slow things down.
