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Key Takeaways from China's Pilot Plan for Segmented Production of Biological Products
Recently, the National Medical Products Administration (the "NMPA") issued the "Pilot Work Plan for the Segmented Production of Biological Products" (the "Pilot Plan"), introducing a pilot initiative for the segmented production of biological products. This represents a breakthrough in the regulation of segmented production, a long-awaited achievement in the biopharmaceutical industry. This breakthrough suggests the possibility of cross-provincial and even cross-border production of biological products, which marks the significant progress in optimizing resource allocation, reducing production costs, and improving production efficiency, and will promote the integration of China's biopharmaceutical industry into the global market, enhancing international competitiveness. In this article, we analyze the impact of the Pilot Plan, including the types of pilot products, requirements for pilot enterprises, international/cross-border collaboration, and tightened regulatory requirements. We hope to share our insights from these perspectives to provide a reference for the industry.
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New Measures on Syndicated Loans: Policy Shifts and Insights
The National Financial Regulatory Administration ("NFRA") issued the Administrative Measures for Syndicated Loan Business ("Administrative Measures") on 12 October 2024, which will take effect from 1 November 2024 and shall amend and replace the Guidelines on Syndicated Loan Business issued by the China Banking Regulatory Commission on 1 August 2011 (the “Business Guidelines”). NFRA released a draft of the Administrative Measures for public consultation on 22 March 2024. We summarized and interpreted the major amendments of the consultation draft (the "Consultation Draft") to the Business Guidelines (for more details, please refer to our previous article "Optimizing the Regulation of Syndicated Loan Business — Interpretation of the Administrative Measures for Syndicated Loan Business (Consultation Draft)"). The final version of the Administrative Measures includes several refinements and enhancements compared to the Consultation Draft, and some of these updates address the concerns we highlighted in our article in March.
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Navigating New Network Data Regulation: Highlights and Actions
On 30 September 2024, China's State Council announced the finalized Regulation for the Administration of Network Data Security (《网络数据安全管理条例》, "Network Data Regulation"), which will take effect on 1 January 2025. This regulation provides a framework for personal information (PI) protection, cross-border data transfers, network data security management and the responsibilities of internet platform providers. In this article, we draw on our experience in advising foreign-funded banks on PI protection policies and cross-border data transfers, to outline the key provisions of the regulations, their implications for the operations of these banks and their clients, and to provide guidance on how to align with the new regulatory requirements.
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Han Kun
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