2025年1月全球医药监管动态：中国与国际最新法规指南解读

The pharmaceutical and medical device industries operate within a dynamic and stringent regulatory environment. Staying abreast of new guidelines and draft documents is crucial for ensuring compliance, maintaining product quality, and facilitating successful market entry. This post summarizes significant regulatory updates released by Chinese and international authorities in January 2025, providing a concise overview for industry professionals.

制药和医疗器械行业在一个动态且严格的监管环境中运作。及时了解新的指南和草案文件对于确保合规性、维持产品质量以及促进成功市场准入至关重要。本文总结了2025年1月中国和国际监管机构发布的重要法规更新，为行业专业人士提供简明概述。

Key Domestic (China) Regulatory Updates

1. CFDI | Guidelines for Sterility Assurance in Drug Manufacturing

Release Date: 2025/01/17
This comprehensive 76-page guideline aims to standardize and guide the scientific and effective execution of sterility assurance for drug manufacturers, including Marketing Authorization Holders (MAHs), drug manufacturers, and API registrants. It focuses on controlling contamination and cross-contamination risks during the manufacturing of sterile drugs.

1. CFDI | 《药品无菌保证工艺指南》
发布时间： 2025年1月17日
这份长达76页的综合指南旨在规范和指导药品上市许可持有人（MAH）、药品生产企业及原料药登记人等，在无菌药品生产过程中进行科学、有效的无菌保证。其重点在于控制生产过程中的污染和交叉污染风险。

2. NMPA | Revised Appendices for "Good Manufacturing Practice for Drugs" (2010 Revision)

Release Date: 2025/01/02
These revised appendices strengthen supervision and guidance for sterile drugs and active pharmaceutical ingredients (APIs).

Appendix for Sterile Drugs: Clarifies requirements for ensuring the sterility of terminally sterilized and aseptically processed products, covering aspects like environmental monitoring, cleaning validation, water systems, and sterilization processes. It emphasizes maintaining cleanroom conditions through effective HVAC systems with proper pressure differentials.
Appendix for APIs: Details requirements for the production of APIs, mandating thorough documentation and control over every production step, especially for steps involving materials of animal origin or high-risk processes.

2. NMPA | 《药品生产质量管理规范（2010年修订）》附录修订
发布时间： 2025年1月2日
此次修订的附录旨在加强对无菌药品和原料药（API）的监督指导。

《无菌药品》附录： 明确了确保最终灭菌产品和无菌工艺产品无菌性的要求，涵盖环境监测、清洁验证、水系统和灭菌工艺等方面。强调通过有效的HVAC系统和适当的压差维持洁净室条件。

《原料药》附录： 详细规定了原料药生产的要求，要求对每个生产步骤，特别是涉及动物源性物料或高风险工艺的步骤，进行全面的文件记录和控制。

3. NMPA | Draft Revision of "Good Manufacturing Practice for Medical Devices"

Release Date: 2025/01/15 | Comment Deadline: 2025/02/14
This draft revision seeks to enhance the supervision of medical device manufacturing. Compared to the 2014 version, it introduces significant updates across 13 chapters and 131 articles, with new sections on "License Expansion" and "Entrusted Manufacturing." It emphasizes a product lifecycle approach, urging companies to strengthen their quality management systems and information technology applications.

3. NMPA | 《医疗器械生产质量管理规范》修订草案（征求意见稿）
发布时间： 2025年1月15日 | 意见反馈截止日期： 2025年2月14日
本次修订草案旨在加强医疗器械生产监管。与2014年版相比，其在13章131条中进行了大量更新，并新增了"许可变更"和"委托生产"等章节。它强调产品全生命周期管理，敦促企业加强质量管理体系和信息技术应用。

4. NMPA | Notice on Comprehensively Deepening Reform to Promote High-Quality Development

Release Date: 2025/01/03
This policy notice outlines a series of reform measures to optimize the drug and device review and approval lifecycle. Key initiatives include establishing a "green channel" for clinically急需 innovative products, implementing a "one product, one policy" approach, streamlining clinical trial timelines (potentially to under 30 days for approval), and strengthening intellectual property protection.

4. NMPA | 《关于全面深化审评审批制度改革促进医药产业高质量发展的通知》
发布时间： 2025年1月3日
该政策通知概述了一系列优化药品医疗器械审评审批生命周期的改革措施。关键举措包括：为临床急需的创新产品建立"绿色通道"，实施"一产品一策"方法，简化临床试验时间线（批准时间可能缩短至30天以内），以及加强知识产权保护。

5. CDE | Guidelines for Intermediate Testing of Oral Chinese Herbal Preparations

Release Date: 2025/01/17
These guidelines address common industry questions regarding the requirements for intermediate product testing during the stability study of oral Chinese herbal preparations. They provide clear criteria: studies exceeding 30 days generally require intermediate testing, while those under 30 days should be evaluated case-by-case.

5. CDE | 《中药口服制剂中间体检测研究指导原则》
发布时间： 2025年1月17日
该指导原则旨在解决业界关于中药口服制剂稳定性研究中中间体检测要求的常见问题。它提供了明确的标准：研究超过30天通常需要进行中间体检测，而短于30天的研究则应个案评估。

8. NMPA | Notice on Revising Instructions for Human Albumin Injections

Release Date: 2025/01/13
MAHs are required to submit revised package inserts and labels to the National Medical Products Administration or provincial counterparts by April 8, 2025. Key requirements include:

Revised labels must be submitted concurrently if changes involve labeling.
MAHs must conduct post-marketing studies, implement risk management measures, and educate healthcare professionals and patients.
Healthcare professionals should carefully review the changes for risk/benefit assessment.
Patients should read the instructions carefully and use prescription drugs under medical guidance.

8. NMPA | 《关于修订人血白蛋白注射剂说明书的公告》
发布时间： 2025年1月13日
要求药品上市许可持有人（MAH）在2025年4月8日前向国家药监局或省级药监部门提交修订后的说明书和标签。关键要求包括：

若变更涉及标签，应一并提交修订后的标签。

MAH必须开展上市后研究，实施风险管理措施，并对医护人员和患者进行教育。

医护人员应仔细审阅变更内容，进行充分的获益/风险评估。

患者用药前应仔细阅读说明书，处方药需严格遵医嘱使用。

Key Global Regulatory Updates

1. FDA | Draft Guidance on Complying With 21 CFR 211.110

Release Date: 2025/01/06 | Comment Deadline: 2025/04/06
This draft guidance elaborates on the requirements of 21 CFR 211.110 regarding sampling and testing of in-process materials and drug products. It provides considerations for modern manufacturing technologies and process validation strategies, applicable to both innovator and generic drugs.

1. FDA | 《21 CFR 211.110 合规性考量》草案指南
发布时间： 2025年1月6日 | 意见反馈截止日期： 2025年4月6日
该草案指南详细阐述了21 CFR 211.110关于中间体和药品取样与检验的要求。它为现代生产技术和工艺验证策略提供了考量要点，适用于创新药和仿制药。

2. WHO | Draft Guidance on Points for Continuous Manufacturing

Release Date: 2025/01/07
This draft guidance focuses on the continuous manufacturing of both chemical and biological drug products. It covers critical aspects such as process control strategies, real-time monitoring, system verification/validation, and continuous process verification, aiming to help industry adopt this technology while ensuring product quality.

2. WHO | 《药品连续制造考量要点》草案指南
发布时间： 2025年1月7日
该草案指南关注化学药和生物制品的连续制造。涵盖了工艺控制策略、实时监控、系统验证/确认以及持续工艺确认等关键方面，旨在帮助行业在采用该技术的同时确保产品质量。

3. APIC | FAQ on Data Integrity

Release Date: 2025/01/25
This document addresses frequently asked questions regarding data integrity, covering topics like electronic signatures, audit trails, and data review. It serves as a practical resource to help companies and individuals better understand and implement data integrity requirements to ensure data reliability and compliance.

3. APIC | 《数据完整性常见问题解答》
发布时间： 2025年1月25日
该文件解答了关于数据完整性的常见问题，涵盖电子签名、审计追踪和数据审核等主题。它是一个实用资源，旨在帮助公司和个人更好地理解和实施数据完整性要求，以确保数据的可靠性和合规性。

5. FDA | Draft Guidance on AI for Regulatory Decision-Making

Release Date: 2025/01/07
This draft guidance provides recommendations for using Artificial Intelligence (AI) to support regulatory decisions concerning drug safety and efficacy. It introduces a "predetermined change control plan" framework to help manage the reliability of AI models throughout their lifecycle in specific contexts of use.

5. FDA | 《使用人工智能支持药品和生物制品监管决策的考量》草案指南
发布时间： 2025年1月7日
该草案指南为使用人工智能（AI）支持有关药品安全性和有效性的监管决策提供了建议。它引入了"预定的变更控制计划"框架，以帮助管理AI模型在其特定使用场景下全生命周期的可靠性。

Conclusion and Strategic Implications

The January 2025 updates reflect a clear, global regulatory trend towards enhanced sterility assurance, advanced manufacturing oversight (including continuous manufacturing and AI integration), robust data integrity, and patient-centric risk management (evident in revised labeling requirements). For companies operating in or targeting the Chinese market, aligning with NMPA's reform agenda focusing on innovation acceleration and lifecycle management is particularly critical. Proactively understanding and implementing these evolving requirements is not merely a compliance exercise but a strategic imperative for ensuring supply chain resilience, maintaining market access, and ultimately delivering safe and effective products to patients worldwide.

2025年1月的法规更新反映了一个清晰的全球监管趋势：加强无菌保证、强化先进制造监管（包括连续制造和AI整合）、稳固的数据完整性以及以患者为中心的风险管理（体现在修订的标签要求中）。对于在中国市场运营或目标为中国市场的公司而言，顺应国家药监局以加速创新和全生命周期管理为重点的改革议程尤为关键。主动理解并实施这些不断发展的要求，不仅仅是一项合规任务，更是确保供应链韧性、维持市场准入并最终为全球患者提供安全有效产品的战略要务。

Note: This blog post provides a high-level summary for informational purposes. For detailed implementation, always refer to the official regulatory documents and consult with qualified regulatory affairs professionals.
注：本文仅为信息提供之目的进行高层摘要。具体实施请务必参考官方法规文件并咨询合格的注册事务专业人士。