CRED 8 Presentations

01/07/2024

Potential outcomes at D181

 You are the responsible Regulatory Affairs Manager

 You have explained the Centralised Procedure to your management

 What is the reality? ● Timelines ● Accelerated review

The Organisation for Professionals in Regulatory Affairs

13

Managing Internal Expectations – Duration of 112 recent original MAA reviews

Teriparatide Sun

1095

Rayvow Qdenga

Flu and COVID 19 vaccines Combinations of older medicines

730

365

Procedure Duration (Days)

0

Individual MAA Procedures

Refused Withdrawn Approved

Teriparatide Sun is an authorized generic approved 18 Nov 22

The longer the review the less likely a positive outcome

The Organisation for Professionals in Regulatory Affairs

14