CRED ERP 25

01/07/2025

EMA – new tasks as of 1 March 2022 (and later)

• New tasks (during crisis management) as included in the Regulation concern:

✓ monitoring and mitigating the risk of shortages of critical medicines and medical devices;

✓ providing scientific advice on medicines that may have the potential to treat, prevent or diagnose the diseases causing those crises;

✓ coordinating studies to monitor the effectiveness and safety of medicinal products intended to treat, prevent or diagnose diseases related to the public health crisis;

✓ coordinating clinical trials for medicinal products intended to treat, prevent or diagnose diseases related to the public health crisis;

✓ transferring of the EU Expert Panels for clinical evaluation of certain high-risk medical devices and invitro diagnostics of the Medical Device Regulation to the Agency.

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The Organisation for Professionals in Regulatory Affairs

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EMA – new tasks as of 1 March 2022 (and later)

• To perform these tasks new groups/platforms are being officially established

✓ Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG). Additionally, legal basis for involving ECDC (European Centre for Disease Prevention) to obtain epidemiological data to help forecast medicines needs and to request specific data from Member States and supply-chain stakeholders ✓ A Medical Devices Executive Steering Group on shortages and safety of Medical devices (MDSSG) has been established ✓ Emergency Task force (ETF) responsible for leading the scientific response to a declared public-health emergency (e.g. accelerated scientific advices, advice on clinical trials, undertake reviews of medicines to be used in the public-health emergency and provide recommendations on compassionate use of medicines and on use and distribution of unauthorized medicines) ✓ The Regulation provides a legal basis for the establishment of the vaccines monitoring platform and for DARWIN (Data Analysis Real World Interrogation Network).

NB: New pharma legislation will further extend this mandate

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The Organisation for Professionals in Regulatory Affairs

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