Spring Intro 2023

16/02/2023

MA Application approval

Lifecycle Strategy

Benefit / Risk Assessment

Efficacy

Safety

PIP maintenance

Safety variations

New Indications

Minimizing risks

Expanding Opportunity

Conditional MA

PSURs

Label enhancements

Renewals

RMPs

PAMs

PAES

PASS

Maintaining compliance

EMA/ NCA

MAH

Sunset Clause monitoring GxP inspections PSMF

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Committees of EMA (1)

Committee for Medicinal Products for Human Use (CHMP) ● The CHMP plays a vital role in the authorisation of medicines in the European Union (EU). In the centralised procedure, the CHMP is responsible for: – conducting the initial assessment of EU-wide marketing authorisation applications; – assessing modifications or extensions ('variations') to an existing marketing authorisation; – considering the recommendations of the Agency's Pharmacovigilance Risk Assessment Committee on the safety of medicines on the market and when necessary, recommending to the European Commission changes to a medicine's marketing authorisation, or its suspension or withdrawal from the market. – The CHMP also evaluates medicines authorised at national level referred to EMA for a harmonised position – They also have a a role in providing scientific advice to MAHs, preparation of EU scientific guidelines and harmonisation of scientific guidelines Pharmacovigilance Risk Assessment Committee (PRAC) The PRAC is responsible for assessing all aspects of risk management of human medicines, including: - the detection, assessment, minimisation and communication of the risk of adverse reactions - design and evaluation of post-authorisation safety studies - pharmacovigilance audit. - provides recommendations on questions on PV and risk-management systems to CHMP, CMDh, EMA secretariat and European Commission

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