Spring Intro 2023

03/03/2023

Submission and Validation Phase

Initial MAAs are submitted to the EMA, Rapporteur and Co-Rapporteur, and then enter a period of validation

Objective is to ensure essential elements are included – it’s a technical/administrative check of the dossier rather than a scientific assessment You should include Notes to file to explain if anything is deliberately missing from the file, and might include for example justification for why any scientific advice received has not been followed…

Takes ~10 days – make sure you’re reachable in this time and that your team are ready to respond to your every demand!

Once it’s complete you’ll get a confirmation of validation letter and you can relax! (for a short while)

Note – extended validation will delay MAA procedure start

Access

Submission and validation of MAA

Research and development (several years before MAA)

Pre submission (~18 months before MAA)

EU Commission decision

Evaluation of MAA (~ 1 year)

EMA opinion

Continuous Safety Monitoring

EMA link: Marketing authorisation guidance documents

The Organisation for Professionals in Regulatory Affairs

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Evaluation Phase: Day 0-120

• The rapporteur and co-rapporteur conduct their own independent evaluation of the medicine, using their national team of assessors (eg. clinical, stats., non clinical, quality, etc experts) • They each produce an assessment report, and identify questions to be answered by the Applicant • The Pharmacovigilance Risk Assessment Committee (PRAC) assess the company’s risk management plan • Other CHMP/PRAC members then comment on the rapporteurs assessment report and identify additional questions • In addition to the Rapporteurs, the CHMP also appoint peer-reviewers to ensure rapporteurs assessments are robust • All viewpoints are consolidated into a single assessment report which is sent to the Applicant. • Evaluation is paused while Applicant responds to queries (clock-stop) - upwards of 200 queries is normal for a brand new MAA – project management is a key skill! Split into major and minor objections + start at D80!

Day 1: Start of procedure following validation

Day 80: Receipt of the DRAFT Assessment report from the Rapporteur and Co Rapporteur Day 94: Receipt of DRAFT PRAC Rapporteur Assessment report Day 120: Receipt of the List of Questions as well as the conclusions and review of the data

Day 120: Adoption by CHMP of request for GMP/GLP/GCP inspection, if necessary

Clock Stop (90 days)

Clock Stop (30 days)

Phase 1: 120 Days

Phase 2: 60 Days

Phase 3: 30 Days

EMA link: Marketing authorisation guidance documents

The Organisation for Professionals in Regulatory Affairs

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