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
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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
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