CRED ERP 25

3. Roles and responsibilities in the Centralised Procedure

European Medicines Agency (EMA) • An Agency of the European Commission • EMA provides the

Committee on Human Medicinal Products (CHMP) • Assessment of MAAs and maintenance activities (e.g., review of variations to MAA)

Pharmacovigilance and Risk Assessment Committee (PRAC) • Primarily responsible for assessing EU Risk Management Plans (RMP) and all aspects of risk management • Determines requirement for post-authorisation safety studies (PASS) • Assesses need for additionalrisk

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Preparation of the ‘opinion’ of the CHMP on any question relating to the evaluation of medicinal products for human use (opinion provided by EMAto EU Commission) Opinion based upon review of (Co-)Rapporteur Assessment Reports and selected review of MAA

framework within which the scientific committees perform their assessments

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minimisation measures (e.g., restricted distribution, patient / physician education)

(Co-)Rapporteurs •

EMA Procedure Manager (PM) • Applicant’s primary contact during course of evaluation procedures

EMA Product Lead (EPL) •

Leads the EMA product team Maintains oversight of the medicine throughout its lifecycle Accountable for the overall product knowledge Provides clinical and regulatory science input Supports consolidation of a committee position Facilitates cross-committee discussions and coordinates with the different experts/committees in EMA Reference for the defined products / disease area Should have oversight of all correspondence with Sponsor

Rapporteur and co- Rapporteurs are CHMP members assigned to lead the assessment of the MAA Responsible for the scientific assessment of the dossier Prepare separate Day 80 AR, Day 87 AR Prepare Joint Day 150 AR Propose positive / negative opinion, scientifically justifiable SmPC, conditionsfor use, obligations, RMP Identify need for input from external experts / SAG

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Provision of regulatory procedural guidance Ensures adherence to procedural guidelines and timelines Regulatory scientific support in simpler procedures Maintains process performance metrics Appointed at start of procedure

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Oversees management of procedure

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European Commission • The EC reviews the

Scientific Advisory Group (SAG) • Independent expert scientific advisory group • Convened by CHMP if external expert advice is

‘opinion’ of the EMA and prepares and issues the Final Commission Decision (the EU Marketing Authorisation)

required on specific assessment issue(s) CHMP ask SAG specific question(s) Normally occurs prior to CHMP discussion on the review

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Closed meeting (unlike US advisory committees) Sponsor invited to provide their point of view on issue being addressed Advice given by SAG may be disregarded by CHMP

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