Module 1 2021

30/06/2021

Centralised Procedure

For ATMPs: Commision Advanced Therapies (CAT) involved

• Day 1 - Start of Procedure • Day 80 - Preliminary Assessment Reports by Rapporteur an Co-Rapporteur (sent to CHMP and applicant) • (before Day 120 PRAC Risk Management Plan Assessment report and List of Questions prepared) • Day 120 - List of Questions adopted by CHMP Clockstop • Day 120 - Submission Responses • Day 157 - joint Assessment Report from CHMP and PRAC (Co-)Rapp • Day 180 - CHMP Discussion on the need for adoption or list of outstanding issues Clockstop • Day 181 - submission of responses or oral explanation • Day 194 - CHMP (Co-) Rapp/PRAC Rapp joint Assessment Report • Day 210 - Adoption of CHMP Opinion

• Day 277 - days Final Commission Decision

The Organisation for Professionals in Regulatory Affairs

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 Appointed from the CHMP Members ● Applicant’s proposal/preference not considered ● Appointment (usually) in accordance with expertise (therapeutic area) ● ATMPs: (Co) Rapporteurs appointed amongst CAT Members ● PRAC Rapporteur and Co-Rapporteur Appointed  Spokesperson of the CHMP  Prepares initial Assessment Report  Important for the Applicant ● Maintain good and Open Relationship;  Supported by Product Team ● National experts ● Product Team Lead nominated by EMA; primary contact applicant; liaison between EMA, Rapporteur, Applicant Rapporteur

The Organisation for Professionals in Regulatory Affairs

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