When the mutual recognition
agreement for inspections between EC and USA became effective on
December 1, 1998 a three-year transition period was agreed. During
this transition period the evaluation of the equivalence of GMP in
the EU and the USA was to take place.
Regular meetings for the purpose
of evaluating the status achieved are scheduled to take place during
this transition period. The last meeting of the joint sectorial
committee took place at the end of June.
The meeting revealed very
distinct differences between FDA and the EU as regards the
activities to be completed during the three-year transition period.
The evaluation of the EU member
states by FDA will probably not take place during the agreed
3-year period. A new time-table drawn up by FDA assumes that by the
end of the transition period only one EU country, namely Great
Britain, will have been evaluated. The evaluation of four other
countries, including the Federal Republic of Germany, is not
expected to start before the period between June 2001 and July 2002.
FDA makes no statements
concerning the time-table according to which the remaining EU member
states are to be evaluated. This depends on the availability of
resources within FDA.
From the point of view of FDA the
agreement can only be applied completely in countries in which the
evaluation process has been fully completed.
The EU in turn sees the MRA as a
full package concluded with all the EU member states. It therefore
considers it unacceptable that it should be applied only to some
The EU now demands the agreement
of the USA that the evaluation of all the EU member states take
place within the agreed time frame. It has presented a time-table
for this. If the USA does not agree, the evaluation according to
schedule by November 2001 will become more than questionable.
FDA's new time-table shows that
it has planned 9 months for the evaluation of an EU member country.
In discussions on the evaluation of equivalence many detail-related
questions cropped up as regards the differences between GMP rules
and guidelines in the USA and the EU, causing one to expect
The MRA provides for an exchange
of inspection reports between authorities recognized as equivalent.
However, it was not defined what is to be understood under an
inspection report and in what language it is to be written.
FDA insists on English, but in
the EU these reports are usually compiled in the respective local
language. There is still a distinct need for coordination here.
Would you like to see what your
next GMP inspection report might look like?
A draft for a common format for
an inspection report is currently being used for inspection in the
EU. We already reported on it in our GMP News No. 52. The format is
now also available in German and can be obtained at http://dg3.eudra.org/pharmacos/docs/doc99/gmpformat/gmpform_de.doc
FDA has made it clear that it
also considers the transfer of the entire correspondence between
national authorities and the pharmaceutical company inspected also
forms part of the exchange of inspection reports. It also secures
itself the right to contact the inspected pharmaceutical company
directly - without the consent of the national authority - and, if
applicable, to issue a warning letter and to initiate further action.
From the point of view of FDA the
fact that an authority is recognized as equivalent does not replace
the United States' own laws.
Now the Joint Committee, the next
higher instance, is to be involved in order to clarify the questions
Sven Pommeranz, CONCEPT HEIDELBERG