Module 1 2021

25/06/2021

ICH/ICH-aligned countries: common characteristics

• Adoption of ICH guidelines • Independent review • Information sharing • Harmonisation

• Strong IPR and regulatory framework • Transparent and accountable authorities • Priority review • Rx-OTC separation • R&D facilitated

The Organisation for Professionals in Regulatory Affairs

13

Emerging/Emerged countries catching up

• Adoption of ICH guidelines: in part and tracking • Independent review: in part • Information sharing: regional • Harmonisation: regional convergence • Strong IPR and regulatory framework: developing • Transparent and accountable authorities: developing • Priority review: developing • Rx-OTC separation: developing • R&D facilitated: developing (where there is R&D)

The Organisation for Professionals in Regulatory Affairs

14

7