The State Council's anti-monopoly commission officially issued Anti-Monopoly Guidelines for the Pharmaceutical Sector (the “Guidelines”) on January 24th, 2025. Comprising 7 chapters and 55 articles, the Guidelines aim to provide detailed interpretations of monopolistic practices, enforcement principles and criteria for determining violations, offering a comprehensive framework to tackle anti-competitive behaviors in the pharmaceutical industry. The “Guidelines” became effective on the same day. 

Covering production and business activities across the entire pharmaceutical sector, which includes traditional Chinese medicine, chemical drugs, and biological products, the Guidelines establish a comprehensive regulatory system that spans the entire chain of before, during, and after of the process, form systematic institutional designs including corporate compliance guidance, anti-monopoly reexaminations and investigations, regulation of administrative monopolies, and the transfer of clues related to illegal and disciplinary violations to enhance the scientific rigor, precision, and effectiveness of anti-monopoly regulation.

Here are two aspects related to the Guidelines:

On one hand, it’s specified that monopolistic practices and non-compliance with anti-monopoly investigations in the pharmaceutical sector will be subject to stricter and heavier penalties in terms of the law, thereby strengthening legal deterrence. On the other hand, in the Guidelines, the applicable conditions for exemption and leniency programs are refined, and ‘traffic lights' are set up with specific examples of scenarios that do not constitute monopolistic practices based on the concrete realities of the pharmaceutical sector, clarifying behavioral boundaries and effectively regulating the conduct of businesses in the pharmaceutical field.

The Guidelines will come into effect from the date of the issuance. The Anti-monopoly Guidelines of the Anti-Monopoly Committee of the State Council for the Active Pharmaceutical Ingredients sector will be repealed simultaneously.

From Tencent

January 25th, 2025