According to EMEA, the European regulatory authority, a plan is still
needed as to how to proceed further in order to be able to consider an
extension. Particularly since the EC demands a pledge from FDA that the
evaluation of all the EC states will really be completed during the
extended transition period. FDA is still hesitant in this regard since,
according to Joseph C. Famulare of the Office of Compliance, CDER, MRA
is only being processed as the internally available resources allow.
In the year 2000 the USA already published the sequence in which the
other EC states were to be evaluated:
- Ireland
- Germany
- Spain
- Denmark
- Sweden
- Finland
- Italy
- France
- Belgium
- Austria
- Greece
- Luxemburg
- The Netherlands
- Portugal
According to Famulare, the main reasons why the process is dragging so
much are translation problems and lack of resources. Famulare said that
the paper review of the EC states would be delayed by months since most of
the countries had submitted their documents in their national languages.
The USA then returned the documents to the EC commission asking for them
to be translated since they were not in a position to have the documents
translated themselves. The EC Commission then assured the USA that at
least certain documents would be translated. Famulare said that joint
audits to confirm the inspection practice could not begin before the paper
review had been completed.
The FDA's suggestion of a "rolling implementation" of
individual EC states by the USA was greeted by the Europeans with reserve
since it contradicted the concept of a united Europe.
FDA responded to this with an interesting suggestion for speeding up
the procedure, an "interim step". The idea is for the
participating states to exchange inspection reports already during the
transition phase. With the help of these inspection reports FDA could
decide not to send any inspectors to the individual countries for joint
audits. This seems to be acceptable for the Europeans, too.
The expansion of the EU to include eastern European countries might
cause additional problems. How does FDA want to deal with the new members?
The rapid alarm system which is already in operation is to be expanded.
Unfortunately there are problems here, too. FDA wanted an expansion of the
already existing SOPs to permit an exchange of field alert reports. The
Europeans, however, would rather complete the transition period first. It
was extremely difficult to coordinate the currently valid SOPs within the
EC.
What is more, at present the confirmation by the EC concerning the
handling of confidential commercial information is still pending.
A new aspect concerning the MRA agreement are the critical remarks
of the US industry. They fear that the absence of FDA inspections in
Europe upon completion of the transition period will lead to injustices
in the follow-up measures to inspections. There is also even the fear
in some quarters that fewer pharmaceutical companies will be set up in the
USA.
The former head of the Office of Compliance, Stephanie Gray, has also
warned of inequalities in the strictness of inspections in and outside of
the USA.
The MRA agreement between the EC and Canada , which also became
effective at the end of 1998, but which provided for a transition period
of only 18 months, has been all but forgotten. The operational phase
should actually have started long ago, but here too commencement has been
postponed to the end of 2002.
An MRA agreement between the EC and Switzerland is scheduled for
ratification in mid-2002.
