CRED ERP 25

01/07/2025

Main tasks of the CHMP

• Conducting initial assessment of EU-wide MAAs

• Assessing modifications ( variations ) to an existing EU-MA

• Deliver opinions to European Commission:

- on new medicinal products/variations/renewals/line extensions - on arbitration/referral procedures

• Providing scientific advice and protocol assistance to companies

• Preparing scientific guidelines & regulatory guidance

• Establish Working Parties, SAGs & Expert Groups (Operational expert groups /Temporary drafting groups/ European specialised expert communities=ESECs

• Interaction with other regulators (e.g. ICH process)

• Deliver Scientific opinions to WHO

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The Organisation for Professionals in Regulatory Affairs

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Main tasks of the PRAC

⚫ Responsible for all aspects of the risk management of medicines

• Detection, assessment, minimisation & communication on risk related to medicinal products

• PSURs and signal assessment (for CAPs and NAPs)

• Design and evaluation of post-authorisation safety studies

• Assessments of Urgent/ non-Urgent Union Procedure triggered due to safety concerns (safety referral procedures) • Regulatory oversight of RMP and assessment of outcome of risk minimisation measures in RMP for CAPs (for NAPs only in case of MS request for PRAC advice)

• Advice to CHMP on selected post-authorisation procedures

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The Organisation for Professionals in Regulatory Affairs

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