US FDA GRANTED OBSERVER STATUS TO EUROPEAN PHARMACOPOEIA COMMISSION

GMP News No. 524

GMP News
3 March 2005
 

US FDA GRANTED OBSERVER STATUS
TO EUROPEAN PHARMACOPOEIA COMMISSION

 
The EDQM has announced that the United States Food and Drug Administration (FDA) has been granted Observer status to the European Pharmacopoeia Commission. This status will enable the FDA to participate in the scientific work of the Commission for the elaboration of quality standards in the field of blood products and to benefit from European experience in this area.

This status enables observers to participate in the scientific work of the Commission, to benefit from European experience in this area and to gain access to work on the quality control of medicines and the methods of analysis used.

The observers referred have the right to speak; they may not, however, make proposals unless these are put forward by one of the delegations referred.
The Commission may also, by a unanimous vote of the delegations casting a vote and a majority of the delegations entitled to sit on the Commission, admit to some of its sessions technically qualified observers, such as:

  • observers from Member States of the Council of Europe that are not parties to the Convention;
  • observers from States that are not Members of the Council of Europe;
  • observers from international governmental organisations;
  • observers from international non-governmental organisations.

The Commission may, by a unanimous vote of the delegations casting a vote and a majority of the delegations entitled to sit on the Commission, admit as observers in Groups of Experts or Working Parties, technically qualified persons from states or organisations admitted to the Commission as observers.

Source:

www.pheur.org

 

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