Module 1 2021

30/06/2021

Regulation global environment

EU

US

Japan 10 years

Australia 5 years (similar to regular products)

Market exclusivity 10 years

7 years

Research grants National and Horizon 2021- 2017

e.g. NIH

Governmental funds

-

Financial incentive

Defined by MS/EMA

Tax reduction Potentially

Tax reduction -

“voucher program”

Reconsideration of OD Possibility for accelerated assessment

Yes – after 6 yrs No

Yes

Yes – every 12 months

Yes

Yes

Yes

Yes

Other

Centralized Procedure

Paediatric development exempted

The Organisation for Professionals in Regulatory Affairs

27

Stakeholders in global environment

Patients / care givers Health specialists Academia Health Authorities / regulators Health Technology Assessment (HTA) Politicians

The Organisation for Professionals in Regulatory Affairs

28

14