CRED 8 Presentations

01/07/2024

New proposal Pharma Legislation EC

New Regulation (Reg) • Specific rules for the most innovative medicines such as orphans, antimicrobials • Rules on shortages • EMA governance

New Directive (Dir) • Placing on the market of all medicines • Authorisation and labelling requirements • Strong incentives for access

Several operational aspects will be later drafted via so called Implementing and Delegated acts after adoption of the Regulation and Directive

The Organisation for Professionals in Regulatory Affairs 35

35

Some aspects of the new Directive/Regulation

Digitalisation

Vouchers

Timetables (from 210 days to 180 days)

Restructuring Committees

Bio-hybrid

Shortage management plan

Additional Monitoring disappears

Environmental Risk Assesment

ASMF

No standard 5y renewal, unless…

No RMP for off-patent product, unless…

Borderline products

Priority antimicrobials

Rawdata

Temporary Emergency MA

Regulatory Sandbox

Phased reviews (=Rolling review)

ePI

Scientific advice

Inspections

The Organisation for Professionals in Regulatory Affairs

36

36

Made with FlippingBook Ebook Creator