Spring Intro 2023

30/03/2023

EMA (Centralised) Scientific Advice

Procedure divided into 2 phases • Planning phase with/without a preparatory meeting, and • Evaluation phase without discussion meeting (40 day procedure) or with a discussion meeting (70 day procedure)

Main stages of 70 Day procedure with no Preparatory meeting • Submission & Validation 20 days - appointment of two main reviewers (Coordinators) • 30 Day Evaluation • Day 30 - Assessment Report & List of Issues adopted by SAWP and sent to Applicant • Day 60 – Discussion meeting between Applicant and Coordinators/SAWP to address outstanding issues • Day 63 – Final Coordinators report & advice letter adopted by SAWP • Day 70 – CHMP adopt final advice letter

The Organisation for Professionals in Regulatory Affairs

Centralised Scientific Advice

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National Scientific Advice

Most EU national legislation requires the national regulatory agency to provide a scientific advice service • Timelines 3-4 months; opportunity for F2F meetings • Work with your affiliate Particularly applicable to • Where Co/Rapporteurs are known or where agency members sit on guidelines Working Parties “Expert authority” • To understand/influence divergent EU opinion prior to Centralised advice

Top tip – Quality of advice will depend on the expertise at the agency so select national agencies carefully

The Organisation for Professionals in Regulatory Affairs

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