On August 9, 2024, China’s State Administration for Market Regulation (SAMR) released a draft of the Anti-Monopoly Guidelines for the Pharmaceutical Sector (hereinafter referred to as the “AMGP”) for public comment. The AMGP is intended to supersede the Anti-Monopoly Guidelines for the Active Pharmaceutical Ingredient (API) Sector (hereinafter referred to as the “API Guidelines”) enacted in 2021, which focuses on the regulation of monopolistic behaviors in the API sector of chemical drugs. Compared to API Guidelines, the AMGP expands anti-monopoly regime to the entire pharmaceutical sector, including traditional Chinese medicine, chemical drugs, and biological products.Continue Reading China Proposed New Anti-Monopoly Guidelines for the Pharmaceutical Sector
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Overview of Recent Anti-Corruption Enforcement Actions in the Pharmaceutical Industry in China
On May 8, 2023, the National Health Commission of the People’s Republic of China (the “PRC”), along with 13 other government departments of the PRC, issued the “Key Highlights for Combating Corruption in the Medicine Purchase and Sale Industry and Medical Services Industry for the Year 2023” to launch a comprehensive anti-corruption campaign in the pharmaceutical industry. Subsequently, local health commissions in Beijing, Shanghai, Guangdong, Hainan, and various other provinces and cities in the PRC released notices for corrective actions specifically targeting the pharmaceutical industry. On August 15, 2023, the National Health Commission of the PRC further unveiled the “Questions and Answers Regarding the Comprehensive Anti-Corruption Campaign in the Pharmaceutical Industry,” providing additional direction and guidance on the anti-corruption campaign. All these actions collectively have had and will continue to have a profound impact on the pharmaceutical industry in China.Continue Reading Overview of Recent Anti-Corruption Enforcement Actions in the Pharmaceutical Industry in China