美国 FDA 药品质量办公室（OPQ）于 8 月 17 日发布 2020 财年《药品质量状况》报告，这是 OPQ 连续第三年发布这一报告，“报告总结制药行业向美国患者和消费者提供优质药品能力的关键指标”。识林对报告内容做了全文翻译，供大家阅览。 FDA 在报告中指出，“我们在此报告...

+Draft Guidance for Public Comments 【CDE】关于公开征求《研究者手册中安全性参考信息撰写技术指导原则 (征求意见稿) 》及《安全性参考信息示例 (征求意见稿) 》意见的通知 本指导原则是执行《药品注册管理办法》第二十八条，对于药物临床试验期间出现的可疑且...

China Patent Link System 药品专利链接制度或者药品专利纠纷早期解决机制是指将药品上市审批程序与药品专利纠纷解决程序相衔接的制度。2017年10月，中共中央办公厅、国务院办公厅印发《关于深化审评审批制度改革鼓励药品医疗器械创新的意见》，要求探索建立药品专利链接制度。2019年1...

From November 1st to November 30th, Shilin released 360 updates, including 128 from the National Medical Products Administration (NMPA) and provincial drug regulatory departments, 99 from US FDA, 40 from EU, 8 from UK MHRA, 37 from WHO and 42 origin...

Based on two drafts issued in December 2017 and November 2019 respectively, the CDE issued the Technical Guideline for Conditional Approval of Drug Products (for Trial Implementation) on November 19, 2020. Related documents The contents regarding ...

During the review process, the CDE will notify applicants to add technical information to the original submissions (referred to as amendment), if necessary, or simply require applicants to explicate the original submissions. This line is thus formulated ...

A site master (SMF) is only used by the drug regulatory department to formulate and implement an inspection plan. It shall be prepared by the domestic pharmaceutical manufacturing enterprise holding a Drug Manufacturing Certificate as required. As the p...

There are 17 articles in the Regulations on Annual Reports for Drug Products (Draft), which have not been formally promulgated and implemented. The annual report refers to the report generated by the marketing authorization holder (MAH) by aggregating a...

The document is designed to implement the Vaccine Administration Law of the People’s Republic of China, further standardize the writing of annual reports on vaccine quality by the vaccine MAH, and the MAH to sort out and summarize the manufacturing and...

From the Announcement of the National Medical Products Administration on Direct Reporting of Adverse Reaction by Marketing Authorization Holders (No.66 of 2018), and the Announcement of the National Medical Products Administration on Issuing Guideline for ...

NMPA has released the third edition of the Supervision and Administration of Online Drug Sales (Draft), which had been revised for three years according to the new Drug Administration Law. The Draft is mainly divided into General Provisions, Administra...

Shall submission package for the registration of active pharmaceutical ingredients still be prepared in accordance with the requirements of the Announcement on Issuing the Requirements for Submissions of Chemical Drug Products Under New Registration Categ...

The National Medical Products Administration has issued the Announcement on Adjusting the Review and Approval Procedures for Clinical Trials (No.50 of 2018), and put into practice the acquiescence system for clinical trials and the pre-IND consultation sy...

The CDE revised the Summary of Pharmaceutical Study Information on Phase I Clinical Trial Applications for Chemical Drug Products which attached to the Technical Guidance on Phase I Clinical Trial Applications for New Drugs (No.16, 2018) of the former CF...

In view of the adjustment of the FDA’s CPP issuance policy , the CDE agreed that the FDA approved drug products exported from countries outside of the U.S. will no longer be required at the time of registration. The applicant shall provide screenshots...

2020年9-10月 FDA 和 EMA 药品申请和补充申请报告 识林报告旨在向用户介绍，在2020年9-10月期间美国 CDER 和 EMA 集中审评的药品审评审批情况，包括补充申请。 根据识林药品数据库，9-10 月间 FDA 和 EMA 新药批准和补充申请情况如下： FDA 批准了 14 个 NDA、1 个BL...

根据识林药品数据库，总结了7-8月间FDA和EMA批准的新药和补充申请。 FDA批准了23个NDA、6个BLA和146个ANDA： FDA批准诺和诺德的Sogroya（somapacitan）上市，用于治疗生长激素缺乏症。Somapacitan是一种每周一次的人生长激素类似物，是目前美国市场上唯一一款长效生长激素产品。 FDA...

On October 17, China's National People's Congress (NPC) formally adopted the revised patent law, which will take effect on June 1, 2021. The formal passage of the new Chinese Patent Law marks the most significant change in the intellectual property...

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