Spring Intro 2023

03/03/2023

What is the centralised procedure?

The centralised procedure allows applicants to obtain a single marketing authorisation that is valid in all EU Member States as well as in the European Economic Area (EEA) countries Iceland, Liechtenstein and Norway ● See Regulation (EC) 726/2004 of the European Parliament for further details Applications are made directly to the European Medicines Agency (EMA) and are scientifically evaluated by the appropriate EMA committee ● The Committee for Medicinal Products for Human Use (CHMP) is the European Medicines Agency's (EMA) committee responsible for human medicines A Rapporteur and co-Rapporteur are assigned to lead the evaluation on behalf of CHMP While there may be strategic reasons for choosing one route to authorisation over another (MRP/DCP/National/Centralised), it should be noted that the data requirements and standards governing the authorisation of medicines are the same regardless of the review process

EMA link: marketing authorisation

The Organisation for Professionals in Regulatory Affairs

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Overview Of The Pathway To MAA Approval

There are multiple stages in the pathway to having an MAA approved in the EU, starting with early R&D, and activities continue post-marketing

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: interactive timeline “from lab to patient”

The Organisation for Professionals in Regulatory Affairs

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