China: Food and Drugs Law

License-in/out transactions have become a key strategic approach for innovative drug and medical device (including medical aesthetics) companies to expedite the research and development of the products and expand market presence.

On August 9, 2024, the State Administration for Market Regulation (SAMR) released the Anti-Monopoly Guidelines for the Pharmaceutical Sector (Draft for Public Comment) (hereinafter referred to as the Pharmaceutical Anti-Monopoly Guidelines or the Guidelines) to solicit opinions from the public.

When determining whether the replacement between two groups in a pharmaceutical compound is common knowledge in the art, bioisosterism may generally be considered.