2026.01. 30 本文字数：2393，阅读时长大约4分钟 作者 | 第一财经 吴斯旻 《药品管理法实施条例》（下称《条例》）实施23年，历经三次修订后，新版《条例》将于今年5月 15日起实施。 近年来，中国医药产业发展迅速，已进入全球药物研发第二梯队并稳居全球第二大医药市场。新修订 的《条例》回应了创新药行业发展需求。 一方面，《条例》通过完善和引入药品试验数据保护和市场独占期制度，平衡创新与仿制的关系，鼓 励儿童用药和罕见病用药研发；另一方面，将突破性治疗药物程序、特别审批程序上升到行政法规要 求的层面，缩短药品研制和注册进程；此外对于境外已上市药品获批前商业规模批次产品进口以及符 合条件的创新药分段生产予以支持并完善持有人责任。 国家药监局副局长徐景和30日发表署名文章，对于《条例》如何通过监管创新支持创新药发展进行 了详细解读，第一财经由此总结了四大亮点。 亮点一："数据保护"拓展至含有新型化学成分的药品 药品试验数据保护是与专利保护相并行，鼓励药物研发创新、推动仿创平衡的重要措施。 该制度对药品上市许可持有人（即MAH，下称"持有人"）自行取得且未披露的试验数据和其他数据 实施保护；待保护期限届 ...

国家药监局正积极推动制定《药品试验数据保护实施办法》 《药品管理法实施条例》（下称《条例》）实施23年，历经三次修订后，新版《条例》将于今年5月15 日起实施。 近年来，中国医药产业发展迅速，已进入全球药物研发第二梯队并稳居全球第二大医药市场。新修订的 《条例》回应了创新药行业发展需求。 一方面，《条例》通过完善和引入药品试验数据保护和市场独占期制度，平衡创新与仿制的关系，鼓励 儿童用药和罕见病用药研发；另一方面，将突破性治疗药物程序、特别审批程序上升到行政法规要求的 层面，缩短药品研制和注册进程；此外对于境外已上市药品获批前商业规模批次产品进口以及符合条件 的创新药分段生产予以支持并完善持有人责任。 国家药监局副局长徐景和30日发表署名文章，对于《条例》如何通过监管创新支持创新药发展进行了详 细解读，第一财经由此总结了四大亮点。 一年前，国家药监局已就《药品试验数据保护实施办法（试行，征求意见稿）》向社会公开征求意见。 不过彼时《条例》仍处于修订阶段。 随着新修订的《条例》正式"出炉"，徐景和表示，国家药监局积极推进《药品试验数据保护实施办法》 的制定，聚焦保护范围、保护期限、保护方式等核心要素进行深入论证 ...

Core Insights - The first version of the commercial insurance innovative drug directory has been released, including 19 new drugs from 18 innovative pharmaceutical companies, with a roughly equal share of domestic and imported drugs [1][2] - Approximately 70% of the drugs included are oncology treatments, featuring five high-cost CAR-T products, indicating a significant focus on cancer therapies [1][8] - The inclusion of rare disease medications and Alzheimer's treatments in the directory is expected to enhance commercial insurance payment opportunities and favorable policies for hospital access [1][10] Summary by Category Drug Inclusion - A total of 19 drugs have been included in the first commercial insurance innovative drug directory, with a selection rate of about 16%, aligning with industry expectations [4][6] - The directory features a mix of oncology drugs, rare disease treatments, and Alzheimer's medications, with a notable emphasis on high-priced innovative drugs [1][8] Market Dynamics - The directory's limited number of drugs (around 20) is seen as a strategic move to facilitate implementation and avoid complications in local insurance products [6][10] - The commercial insurance market is expected to leverage the directory to enhance patient access to high-value drugs, particularly in the oncology sector [9][11] Regulatory and Policy Framework - The National Healthcare Security Administration (NHSA) encourages local insurance departments to support the integration of the commercial insurance innovative drug directory into retail pharmacies and monitor pricing [7][14] - The directory aims to provide a reference for various commercial insurance entities, allowing them to negotiate with innovative drug companies without the need for exclusive selections [11][14] Patient Impact - The drugs listed in the directory are characterized by a small patient base or specific indications, minimizing the risk of clinical misuse and aligning with commercial insurance risk management strategies [8][13] - The directory includes several drugs for rare diseases, which are expected to fill clinical gaps and provide essential treatments previously unavailable in China [12][13]