The European Medicine Agencies


During its monthly meeting this week, the European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) focused on the broad spectrum of its responsibilities which cover all aspects of the risk management of the use of medicines. The Committee did not initiate or conclude a referral. More information on all ongoing safety reviews is included in the table below.

The PRAC’s full range of work includes pre-authorisation activities, such as the assessment of risk-management plans for medicines under evaluation including any studies or risk minimisation activities planned for authorised use. Post-authorisation activities also include risk management planning as well as the evaluation of periodic safety update reports (PSURs) to assess the safety and benefit-risk balance of a medicine throughout its lifecycle. The PRAC also evaluates safety signals, a key public-health function that ensures that new or changing safety issues are rapidly detected, evaluated and, when appropriate, product-labelling changes or restrictions are introduced for the benefit of patients.

“The switch of the healthcare system to the insurance model will start in 2017 and it will last for three years. The transformation will begin from the launch of family medicine of the European model on the basis of the primary chain of the Ukrainian healthcare system (out-patient hospitals and ambulance clinics),” Kovtoniuk said.

He said that the introduction of insurance medicine would be accompanied minor changes to legislation.

The Agency plays an important role in the development, approval and monitoring of medicines for older people.

The Agency is responsible for the evaluation of new medicines in the EU, including medicines for diseases affecting older people. These include all medicines for neurodegenerative conditions, which affect the way the brain and nervous system work, such as Alzheimer’s disease and Parkinson’s disease. The Agency is also responsible for evaluating medicines for cancer and diabetes.

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