210
Days CP Timeline
27+
EU Member States
eCTD
EU CTD Format
CHMP
Scientific Committee
EU Authorization Procedures
Centralized Procedure (CP)
EMA/CHMPMandatory for biotech, orphan drugs, HIV, cancer, neurodegenerative diseases. Results in EU-wide authorization.
Decentralized Procedure (DCP)
RMS + CMSFor products not yet authorized in any EU state. Applicant chooses Reference Member State.
Mutual Recognition (MRP)
RMS + CMSFor products already authorized in one EU state. Recognition by other states.
National Procedure
NCAAuthorization in single member state only. Rarely used for new products.
Centralized Procedure Timeline
Pre-Submission
Scientific Advice
Optional meeting with CHMP for development guidance
Pre-submission Meeting
Discuss submission strategy and validate timeline
Parallel Scientific Advice
Joint advice with HTA bodies (EUnetHTA)
Submission & Validation
MAA Submission
Electronic submission via CESP or eAF
Validation
10-day validation of completeness
Procedure Start
Day 0 - clock starts for 210-day procedure
Assessment
Day 80 Assessment Report
Rapporteur and Co-Rapporteur initial assessment
Day 120 List of Questions
CHMP adopts consolidated list of questions
Clock Stop
Applicant time to respond (usually 3-6 months)
Day 180 Joint Assessment
Assessment of responses
Opinion & Decision
Day 210 Opinion
CHMP issues positive or negative opinion
EC Decision
67 days for European Commission decision
Marketing Authorization
Valid in all EU member states
Reference Documents
EMA Guideline on Bioequivalence
CHMP guideline on the investigation of bioequivalence
Document Viewer
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Notice to Applicants Volume 2
EU pharmaceutical regulatory framework and procedures
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Key Legislation
2001/83/EC
EU Medicinal Products Directive
Reg 726/2004
Centralized Procedure Regulation
CTD Guidance
EU Module 1 Specifications
Vol 2A-C
Notice to Applicants
CHMP Guidelines
Scientific Guidelines
GMP Annex 15
Qualification and Validation