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    CHMP Meeting

    09.05.2017
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    The Committee for Medicinal Products for Human Use (CHMP) is the European Medicines Agency's (EMA) committee responsible for human medicines. Its members and alternates are nominated by corresponding National Competent Authorities. They are chosen based on the level of their qualifications and expertise in scientific assessment of medicinal products.

    The CHMP plays a pivotal role in the authorisation of medicines in the European Union (EU). In the centralised procedure, the CHMP is responsible for:

    • conducting the initial assessment of EU-wide marketing authorisation applications;
    • assessing modifications or extensions (‘variations’) to an existing marketing authorisation;
    • considering the recommendations of the Agency's Pharmacovigilance Risk Assessment Committee on the safety of medicines on the market and, when necessary, recommending to the European Commission changes to a medicine’s marketing authorisation, or its suspension or withdrawal from the market.

       

    Also, the CHMP evaluates medicines authorised at national level that are referred to EMA for a harmonised position across the EU. For more information, see Referral procedures.

     

    In addition, the CHMP and its working parties contribute to the development of medicines and medicine regulation, by

    • providing scientific advice to companies researching and developing new medicines;
    • preparing scientific guidelines and regulatory guidance to help pharmaceutical companies prepare marketing authorisation applications for human medicines;
    • working with international partners on the harmonisation of regulatory requirements.

     

    The CHMP's assessments are based on a comprehensive scientific evaluation of data. They determine whether the medicine meets the necessary quality, safety and efficacy requirements and whether it has a positive risk-benefit balance. An internal peer-review system safeguards the accuracy and validity of the opinions of the committee.

    The joint Strategic Review and Learning Meeting of the CHMP and the Pharmacovigilance Risk Assessment Committee (PRAC) will take place in Radisson Blu Hotel Olümpia, Tallinn, October 17-18.