On Nov. 18, China issued the Anti-Monopoly Guidance for Active Pharmaceutical Ingredients (hereafter referred to as API Anti-Monopoly Guidance or Guidance), clarifying regulations against monopoly agreements, abuse of market power, and concentration of undertakings in the API industry.1
The API Anti-Monopoly Guidance, published by the State Council’s Anti-Monopoly Committee, marks China’s first detailed guidance for enforcing the Anti-Monopoly Law in the pharmaceutical industry.
This article is meant to introduce the Guidance’s application scope, interpret its highlight anti-monopoly regulations, and analyze its influence on China’s pharma industry.
API Anti-Monopoly Guidance’s Application Scope
The Guidance applies to
APIs: the active ingredients which serve as effective components in finished drug products, including chemical drug products’ active ingredients and traditional Chinese medicines’ raw materials. and
chemical raw materials and pharmaceutical intermediates used for producing APIs and pharmaceutical excipients in the upstream supply chain .
Baipharm, 26 November 2021