GMP News No. 524
3 March 2005
GRANTED OBSERVER STATUS
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
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.