Module 1 2021

25/06/2021

USA FDA cf China NMPA

China – NMPA (National Medicinal Product Administration)

USA – FDA

• Around 12000 total employees • 400 pharma companies, 300 biotech companies • Excellent infrastructure, • Progressive, innovative, transparent, accountable • PDUFA - set standards for review timelines • IND review fast

• Drug technical reviewers: only 70-80 in CDE by year 2015. The key challenge faced is resource: • Approx. 5000 pharma manufacturers, including biotech companies • 7,000-10,000 applications yearly including IND/NDA/ANDA/variation/renewal etc. • Need to improve technical knowledge and better understand international review practices (FDA/EMEA) • New hiring of CDE reviewers started in 2015. By early 2017, there are 400+ reviewers. By early 2018, it became 800+.

The Organisation for Professionals in Regulatory Affairs

19

Harmonisation?

GCC

The Organisation for Professionals in Regulatory Affairs

20

10