Medical Device Legal News with Sam Bernstein: Episode 11
This is the second in our 2025 Year in Preview series examining important trends in white collar law and investigations in the coming year. We will be posting further installments in the series throughout the next several...more
China's State Administration for Market Regulation (SAMR) has released the draft Compliance Guidelines for Healthcare Companies to Prevent Commercial Bribery Risks (Draft Guidelines) for public comment. The Draft Guidelines,...more
While the definition of sensitive personal information in China has always been different to other jurisdictions, with a focus on risk of harm at its heart, new draft guidance should make it easier for organisations to map...more
On June 30, 2023, China’s antitrust authority – the State Administration for Market Regulation (SAMR) – released draft guideline on standard essential patents (SEPs) for public comment. The comment period ends on July 29,...more
Report on Research Compliance 18, no. 9 (September, 2021) - A former Harvard Medical School and Massachusetts General Hospital (MGH) researcher who was the principal investigator on a 2014 NIH award of $939,495.27 and...more
The Chinese Ministry of Ecology and Environment (MEE), formerly the Ministry of Environmental Protection (MEP), issued the “Measures on the Environmental Management of New Chemical Substances” (MEE Order No. 12) on April 29,...more
On April 26, 2018, the China Drug Administration (CDA) released a draft guideline of implementing rules on pharmaceutical data exclusivity for public comments. The draft guideline expands the scope of data protection from...more
This is the first time the China Drug Administration (CDA) provides details on how the data exclusivity applies to pre-clinical and clinical data submitted to the agency. Companies with plans to launch pharmaceutical products...more
The Cyberspace Administration of China (CAC) issued Draft Measures for public comment on April 11 on Security Assessment for Cross-border Transmission of Personal Information and Critical Data (the Draft Measures). The Draft...more
Popularity of the EB-5 Immigrant Investor Program has surged in recent years among foreign investors from mainland China. As a result, the demand for EB-5 visas by foreign investors born in mainland China has exceeded total...more
Recently, the National Development and Reform Commission (NDRC) and Ministry of Commerce (MOFCOM) of the People’s Republic of China (PRC) jointly released a draft of the new Foreign Investment Guidance Catalogue for public...more