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  • European Medicines Agency (EMA)
    The European Medicines Agency is a decentralised agency of the European Union responsible for the evaluation, supervision and safety monitoring of medicines
  • Medicines | European Medicines Agency (EMA)
    The European Medicines Agency (EMA) facilitates development and access to medicines for countries within the European Union (EU) EMA evaluates applications for marketing authorisation submitted via the centralised procedure, monitors the safety of medicines across their lifecycle and provides information to healthcare professionals and patients
  • Human regulatory: overview - European Medicines Agency (EMA)
    Information on the regulation of medicines for human use in the European Union (EU), with a focus on the centralised procedure The European Medicines Agency (EMA) plays a key role in this procedure
  • Whats new | European Medicines Agency (EMA)
    Evaluation, supervision and safety monitoring of medicines in the EU
  • Scientific guidelines - European Medicines Agency (EMA)
    The European Medicines Agency's Committee for Medicinal Products for Human Use prepares scientific guidelines in consultation with regulatory authorities in the European Union (EU) Member States, to help applicants prepare marketing authorisation applications for human medicines Guidelines reflect a harmonised approach of the EU Member States and the Agency on how to interpret and apply the
  • News | European Medicines Agency (EMA)
    Search EMA's news announcements Ojemda addresses unmet need for patients aged 6 months and older with paediatric brain tumour with BRAF alterations
  • Search | European Medicines Agency (EMA)
    This page addresses common questions from marketing-authorisation holders (MAHs) about Article-61 (3) notifications It outlines the European Medicines Agency's (EMA) position on issues typically discussed with MAHs during the post-authorisation phase
  • News and events - European Medicines Agency (EMA)
    The European Medicines Agency's news announcements, information on meetings and events, public consultations and related information
  • National registers of authorised medicines - European Medicines Agency . . .
    The national medicine registers in the different Member States of the European Union (EU) and European Economic Area (EEA) contain information on medicines authorised in those countries, including links for the summary of product characteristics (SmPC) and the package leaflet
  • Marketing authorisation | European Medicines Agency (EMA)
    The European Medicines Agency (EMA) is responsible for the scientific evaluation of centralised marketing authorisation applications (MAA) Once granted by the European Commission, the centralised marketing authorisation is valid in all European Union (EU) Member States, Iceland, Norway and Liechtenstein





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