Module 1 2021

25/06/2021

China Regulatory Reform since 2015: Summary Encourages new drug innovation/Accelerate Review Process  Priority review process in place in 2016

More CDE reviewers in place: 80 (2015) to 800+ (2018)



 IND timeline improvements: 12M, to 6M, to 3M (60WD silent approval)  NDA timeline improvements: 18-24M to 6M-9M  RA/EC in performed in parallel: startup timeline around 10M

Pre-IND and pre-NDA meetings encouraged



No need for foreign CPP for NDA submission



 Conditional approval on rare disease, or serious life-threatening diseases More Harmonisation with Global Requirements  Open FIH phase I to foreign company  CFDA joining ICH in July 2017  ICH guidance implementation

 Improved timelines means that Global trials can now incorporate China.  Global data is now acceptable for China registration Strengthen Quality  Clinical trial data quality: self-inspection and then audited by NMPA  Generic drug quality: Re-evaluation of quality and safety-efficacy  New MA holder system: emphasises the responsibility of the MAH, strengthening the responsibility for drug quality and safety reporting © 2014 DIA, Inc. All rights reserved.

The Organisation for Professionals in Regulatory Affairs

29

Rise of Asian R&D companies will adjust paradigm

Use data gathered in US/EU to justify registration in Asia

Japanese, Korean, Chinese, Taiwanese enterprises will seek access to US, EU

The Organisation for Professionals in Regulatory Affairs

30

15