China’s long-awaited Personal Information Protection Law (PIPL) has potentially significant implications for pharmaceutical and medical device companies doing business in China or with the market in China. Personal health information is considered sensitive personal information and is now subject to enhanced data compliance requirements for collection, processing, and cross-border transfer. After two rounds of draft versions, the PIPL was finally passed by the Standing Committee of the National People's Congress on August 20, 2021 and will become effective November 1, 2021.
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The FDA announced on March 18 that it is suspending onsite routine domestic inspections in an effort to slow the spread of the coronavirus (COVID-19) and help flatten the pandemic curve.
The US Court of Appeals for the Federal Circuit’s February 10 decision in Acetris Health, LLC v. United States provides important guidance regarding the determination of a product’s country of origin, which is a gating issue for prescription drug products the US government is permitted to buy.
The PRC Ministry of Finance has announced it will audit 77 randomly selected drug makers in China, examining the companies’ costs and profits to determine the reasonableness of their drug pricing mechanisms, in a bid to drive down medical costs.