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GMP News No. 13
25. September 1998
Philippe Meyer von der EG-Kommission spricht über den aktuellen Stand
zum MRA-Abkommen:
MRA 'Plus'?
On September 10, Philippe Meyer of DG I of the European Commission spoke at an
evening reception organized by APIC and CONCEPT HEIDELBERG in Brussels. Among other
things, Mr. Meyer is wokring on the trade agreement between the USA and the EC. The MRA
which, in addition to the pharmaceutical sector, is concerned with other industries is
primarily an agreement for the reduction of trade restrictions. Mr. Meyer explained that,
at the beginning of the MRA negotiations it was not even clear that the pharmaceutical
sector was to be integrated. To the surprise of all concerned and in contrast to
information to the contrary, the three-year transition period has not yet begun! Since
June of this year the EC has concluded all the administrative implementation procedures,
but the USA (FDA) has not yet reached the same stage. It is feared that the FDA wishes to
enforce an ‘MRA Plus’, i.e. additional demands, and that this will further delay
the implementation phase. One thing, however, seems to be clear: The ideal that the
EC’s GMP inspectorates will be evaluated as a unit, cannot be realized. According to
this, some countries will be recognized as equal earlier while others are audited by the
recognized member states.
In addition to the evaluation system of the joint inspections the individual countries
must prove that they have established the formal framework (training programs for
inspectors, guidelines for implementation, etc.). It remains to be seen whether Germany
will be successful in supplying the proof of equivalence.
Additional MRAs concerning the pharmaceutical sector, e.g. of the EU with Canada, New
Zealand, Australia and Switzerland are currently soon to be passed. An MRA concerning the
active ingredients and excipients, but not the finished medicinal product, has been
concluded with Israel. |
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