为提升药品注册审评效率、加强监管信息化水平，国家药品监督管理局（NMPA）近日宣布，化学药品和生物制品的注册申请将全面实施电子申报制度。根据新规，自2024年起，所有新提交的化学药和生物制品上市许可申请、补充申请及再注册申请，均须通过国家药监局指定的电子申报平台进行提交，不再接受纸质材料。电子申报系统将实现申报资料的标准化、结构化管理，有助于加快审评流程、减少人为差错，并提升数据可追溯性与安全性。同时，该举措也与国际通行做法接轨，有利于我国医药企业参与全球药品注册与合作。申请人需提前熟悉电子申报技术要求，包括文件格式（如PDF/A）、电子签名规范及元数据标准等，确保资料合规上传。此举标志着我国药品注册管理向数字化、智能化迈出关键一步，不仅优化了营商环境，也为公众用药安全提供了更高效的技术保障。
To enhance the efficiency of drug registration reviews and strengthen regulatory digitalization, China’s National Medical Products Administration (NMPA) recently announced that electronic submissions will be mandatory for all registration applications of chemical drugs and biological products. Starting in 2024, all new marketing authorization applications, supplemental applications, and re-registration submissions for chemical and biological products must be filed exclusively through NMPA’s designated e-submission platform—paper submissions will no longer be accepted.The electronic submission system enables standardized and structured management of application dossiers, accelerating review timelines, reducing human errors, and improving data traceability and security. This move also aligns China’s regulatory practices with international standards, facilitating greater participation by domestic pharmaceutical companies in global drug registration and collaboration. Applicants are advised to familiarize themselves in advance with technical requirements, including acceptable file formats (e.g., PDF/A), electronic signature protocols, and metadata standards, to ensure compliant submissions.This policy marks a significant step toward digital and intelligent drug regulation in China, optimizing the business environment while providing more efficient technological safeguards for public drug safety.
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