Regulatory Dynamics

• 

  Comparison of the Requirements of 'Chemical Drug Registration Classification and Application Materials'

  2020-05-01
• 

  Medical Policies Weekly (Iusse 10， 2020）

  Edited by CRO_Yeedozencom

  2020-05-01
• 

  No. 57 Document- NMPA issued “Good Clinical Practice (New Version)”, which will be carried out on July 1st, 2020.

  2020-04-27
• 

  Drug Registration Regulation (New)

  Decree of the State Administration for Market Regulation
  No. 27

  2020-04-08
• 

  Regulations for Supervision of Drug Production

  Drug Manufacturing Surveillance Regulation has been deliberated and adopted at the first council meeting of the State Administration for Market Regulation in 2020 on Jan 15th,2020. It is hereby promulgated and shall be implemented by Jul 1st,2020.
  

  2020-03-31
• 

  Guidelines for Classification of Adverse Events in Clinical Trials of Preventive Vaccines

  为进一步规范预防用疫苗临床试验的安全性评价，加快不良事件分级标准与国际接轨，国家药品监督管理局组织起草了《预防用疫苗临床试验不良事件分级标准指导原则》，并于2019年12月31日予以发布。2005年原国家食品药品监督管理局发布的《预防用疫苗临床试验不良反应分级标准指导原则》（国食药监注〔2005〕493号）废止。

  2020-01-06