Spring Intro 2023

03/03/2023

Centralised procedure timetable

Like all EMA procedures, a strict timetable must be adhered to & is critical for planning:

EMA link: Initial (Full) Marketing Authorisation application assessment timetables

The Organisation for Professionals in Regulatory Affairs

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Opinion Phase

Negative CHMP Opinion • You should know well in advance this is coming. Day 157 assessment report will contain recommendation for negative opinion • Prepare for the oral explanation – possibility for issues to be resolved on the day • Options in case of negative opinion: - Can you negotiate a second clock stop and 2nd OE? - Withdrawal? Still made public on EMA website - Accept negative opinion and request a re-examination. New Rapporteurs are assigned - Accept negative opinion Positive CHMP Opinion • Before Day 210: Final (English) SmPC, PIL, mock-ups, list of post-authorization commitments • Day 210: CHMP adopts Opinion, Assessment Report and timetable for translations

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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