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Top 10 Q&As on 2023 China Healthcare Anti-Corruption Initiatives
Recently, China's healthcare industry has been subject to a rigorous inspection and rectification initiatives focusing on anti-corruption. These initiatives have attracted widespread attention in the industry, and we have received numerous media and customer inquiries regarding such issues. Based on our observations, this round of anti-corruption initiatives is not short-term with respect to its duration or effect, but is intended to be an in-dept rectification project lasting for at least one year with inspections and enforcement to be carried out in a more regular manner at a later stage. The direct goal of these anti-corruption initiatives is to purge some entrenched, corrupt unlawful activities in China's healthcare industry, and the vision is to lead the industry towards healthier development.
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The New U.S. Executive Order Compounds Compliance Dilemmas
On 9 August 2023, U.S. President Joe Biden signed the Executive Order on Addressing United States Investments in Certain National Security Technologies and Products in Countries of Concern (the "Executive Order"), to regulate U.S. persons engaged in transactions or investment activities in China (including mainland China, Hong Kong and Macau) that involve certain technologies and products. The U.S. Department of the Treasury (the "Department of Treasury") issued on the same day an Advance Notice of Proposed Rulemaking (the "ANPRM") to seek public comments in formulating the regulations to implement the Executive Order and to clarify its scope.
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China DCT Regulation and Implementation
The concept of "patient-centered" has become the core guiding principle in current research and development ("R&D") of drugs. "Patient-centered" drug R&D refers to the process of drug discovery, design, implementation and decision-making based on the patient's point of view, with the aim of efficiently developing clinically valuable drugs that better meet the needs of patients. Decentralized Clinical Trials ("DCT") are a new type of clinical trial that embodies the "patient-centered" concept, providing new solutions and motivation for drug R&D activities for marketing registration purposes. According to the latest Technical Guidelines for the Implementation of Patient-Centered Drug Clinical Trials (for Trial Implementation) ("Technical Guidelines for Implementation") released by the Center for Drug Evaluation ("CDE") of the National Medical Products Administration ("NMPA") on July 27, 2023, DCT refers to a new patient-centered clinical trial model, the implementation of which is not limited to the traditional on-site clinical trials. In simple terms, usually, DCT would be conducted using telemedicine as well as mobile or local medical care, allowing clinical trials to take place remotely while the subjects can remain at home.
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Han Kun
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