CRED 8 Presentations

01/07/2024

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. 17

The Organisation for Professionals in Regulatory Affairs

17

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

• To perform these tasks new groups are being established/formalised

 The role of the current EU Executive Steering Group on Shortages Caused by Major Events will be formalized

(MSSG). Additionally, the Regulation provides a 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) will be established

 Current Emergency Task force will be formalised 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). 18

The Organisation for Professionals in Regulatory Affairs

18