What is Product Information Files, PIF?
卫生福利部食品药物管理署于2019 年5月30日公告「化妆品产品信息档案管理办法」及「应建立产品信息档案之化妆品种类及施行日期」，依据此公告，现有在2024 年 6 月 30 日前有效的「特定用途化妆品」许可证将转换为「产品信息档案」（Product Information Files, PIF）。
An Overview of Software as Medical Device
In this ever-changing generation, what was once envisioned as Software as a Medical Device (SaMD) is no longer just a concept and is progressively becoming a reality. SaMD primarily supports various medical activities within medical care institutions, including:
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What are Real World Data and Real World Evidence?
The Real World Data, RWD, is the data collected in real healthcare environment, but not the data from the strictly controlled clinical trials. The sources of the RWD can include any data related to health status or healthcare processes routinely collected such as hospital electronic heath record, National Health Insurance Research Database, post-marketing surveillance information, and data from wearable devices.
Regulatory Affairs Specialist
Job Description:
Conduct product registration, license applications/changes, and document writing for pharmaceuticals, medical devices, cosmetics, and food products. Compile product information according to relevant regulatory requirements and procedures, ensuring compliance with both domestic and international authority.
Regulation Amendments for Reporting Serious Adverse Reactions of Medicaments
The regulations for reporting severe adverse reactions of medicaments are established according to Article 45-1 of the Pharmaceutical Affairs Act and have been in effect for 20 years. The Ministry of Health and Welfare now references requirements and standards from the United States, European Union, Japan, and other countries, and aligns with the implementation of the Medical Devices Management Act. As the original regulations in the Pharmaceutical Affairs Act no longer apply to medical devices, the regulations and their title have been revised to 'Regulations for Reporting Severe Adverse Reactions of Medicaments'. These amendments will comprehensively take effect on January 1, 2025. The following are the key points of amendments to the regulations.
