Track CHMP meeting schedules, approval timelines, and key regulatory deadlines for the European Medicines Agency. Essential planning tool for European submissions.
Committee for Medicinal Products for Human Use - Official Meeting Dates
13-16, 27-30
10-13, 24-27
10-13, 24-27
7-10, 28-May 1
12-15, 26-29
9-12, 23-26
14-17, 28-31
No meeting (summer break)
8-11, 22-25
13-16, 27-30
10-13, 24-27
8-11
Note: CHMP opinions are typically published 2-3 weeks after each meeting. Agendas and highlights are available on the EMA website following each session.
Standard timeline from MAA submission to European Commission decision (approximately 210 days + 67 days)
Marketing Authorization Application (MAA) submitted via centralized or national procedure
EMA validates application completeness. Requests missing information if needed.
Rapporteur and Co-Rapporteur prepare assessment reports. CHMP reviews.
List of questions sent to applicant regarding deficiencies or clarifications needed
Applicant submits responses to questions (clock stops during this period)
Rapporteurs assess responses. May request additional information or oral explanation.
CHMP adopts final opinion (positive or negative) on marketing authorization
European Commission adopts final legally binding decision based on CHMP opinion
Published monthly after CHMP meetings
Frequency: ~2-3 weeks after meeting
Impact: High - Indicates upcoming marketing authorizations
Draft guidelines open for stakeholder comments
Frequency: Ongoing - check quarterly
Impact: Medium - Shape future regulatory requirements
EMA publishes priorities and planned activities
Frequency: Q4 annually (typically November)
Impact: High - Strategic planning for next year
Applications for scientific advice meetings
Frequency: Monthly - typically 2 months before desired meeting
Impact: High for applicants
Safety reviews and harmonization procedures
Frequency: As needed - check monthly
Impact: High - May affect marketed products
Typical timing for major guideline updates by therapeutic area (subject to change)
Priority: High
Typical Updates: Q1, Q3 typically
Priority: High
Typical Updates: Q2, Q4 typically
Priority: High
Typical Updates: Q2, Q3 typically
Priority: Medium
Typical Updates: Ongoing
Priority: Medium
Typical Updates: Q1, Q3 typically
Priority: Medium
Typical Updates: Q4 typically
Avoid August (CHMP summer break) and December (reduced staffing) if possible
Agendas published before meetings—track competitor products and relevant discussions
Build 3-6 month buffer into project timelines for questions and responses
Or use RegulatoryAlerts to automatically track all EMA updates filtered to your areas
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