[PDF] eu regulatory authority

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  • What is the EU regulatory authority?

    Regulatory Authorities
    The primary regulatory bodies in the European Union (EU) are the European Parliament, the Council of the European Union, and the European Commission.

  • What is the EU version of the FDA?

    European Medicines Agency (EMA) : EMA is a decentralized body of the European Union, located in Amsterdam in the Netherlands.
    It is responsible for the scientific evaluation, supervision, and safety monitoring of medicines for human and veterinary use in the EU.

  • Is the EMA a regulatory authority?

    EMA is one of the tree components of the regulatory framework of medicines in the EU, together with the European Commission and regulatory Authorities from the EU-EEA countries.

  • Is the EMA a regulatory authority?

    The EMA is the European Union's equivalent to the U.S.
    Food and Drug Administration (FDA). The EMA is sometimes called the European Medicines Evaluation Agency or EMEA, although this is not its official name.

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