Read The Fine Print: China's New Data Protection Plan Has Some Catches

17 May 2018

China SDA's newest proposal gives six and 12 years' data protection for innovative new drugs and therapeutic biologics, respectively, but certain terms and conditions apply.

Sand running through the bulbs of an hourglass measuring the passing time in a countdown to a deadline, on a dark background with copy space. — DATA PROTECTION TERMS PROPOSED IN CHINA • Source: Shutterstock

China's State Drug Administration (SDA) has proposed "encouraging" six-year and 12-year terms to protect clinical data for new drugs and biologics, but legal experts say many uncertainties remain.

Per the SDA proposal, released April 25, the newly established regulatory agency said the draft is designed to implement and...