中国NMPA申请加入PIC/S

JoanneLow

中国NMPA申请PIC/S会员资格，向全球监管合规迈出重要一步！ 此举凸显了我们对确保中国制药行业监管合规和产品安全的承诺。 获得 PIC/S 会员资格通常需要 3 至 6 年时间。 评估期间，可能需要实施PIC/S委员会建议的各种变更和改进； 如有必要，PIC/S代表团将进行后续评估访问，以验证纠正措施的适当性。

为了成功完成这一旅程，所有中国制药商都必须审查 PIC/S 指南和出版物，以了解其潜在影响。 对于加工多种产品的制药商来说，《PIC/S 健康暴露限值设定指南》至关重要，需要仔细审查。 （见附件）

欢迎联系我洽谈！ 随时欢迎您提出想法和问题。 >> jlow@affygility.com

PIC/S新闻网站：https://picscheme.org/en/news/china-applies-for-pics-membership#:~:text=Geneva%2C%2020%20November%202023%3A,%2FS%20pre%2Daccession%20process.

China's NMPA has taken a significant step towards global regulatory alignment by applying for PIC/S membership! This move underscores the commitment to ensuring compliance and product safety in the Chinese pharmaceutical landscape. It usually takes between 3 and 6 years before PIC/S Membership is achieved. During the assessment period, various changes and improvements recommended by the PIC/S Committee may have to be; if necessary, follow-up assessment visits are undertaken by a PIC/S delegation to verify the suitability of corrective implemented actions.

To navigate this journey, it's crucial for all Chinese pharmaceutical manufacturers to review the PIC/S guidelines and publications, understand their potential impact. For pharmaceutical manufacturers processing multiple products, the PIC/S Guideline on Setting Health Based Exposure Limits will be key and require careful review. (see attached)

Feel free to reach out to me for a discussion! Your thoughts and questions are always welcome. >> jlow@affygility.com

PIC/S News Website: https://picscheme.org/en/news/china-applies-for-pics-membership#:~:text=Geneva%2C%2020%20November%202023%3A,%2FS%20pre%2Daccession%20process.

老K

谢谢分享

准圣级药老

中国也就三年时间

琦瑞福生

上次验证培训的时候，马老师说大约2026年

hayao202yao

选择省做代表吧

xqliu

学习了，谢谢提供分享。

知行致用

谢谢分享     

小邢

学习了，谢谢提供分享。