Effective on January 23, 2025, new Guidelines has been approved to regulate and clarify monopolistic practices in the pharmaceutical sector, to strengthen the enforcement of the China Antimonopoly Law and other Anti unfair competition regulations. The Guidelines define the Relevant Product Market primarily based on demand-side substitutability and establishes a Safe Harbor framework to assess agreements that are not considered anti-competitive.
Companies are required to demonstrate that their agreements have no impact on drug prices or supply, with particular emphasis on preserving competition and ensuring proper management of BMI funds. The Guidelines also distinguish substitution criteria for procurement tenders and highlight potential intersections with rules on unfair competition.