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 member states.

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 additional delays.

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 still unanswered.

Source:www.eudra.org/emea.html

Author: Sven Pommeranz, CONCEPT HEIDELBERG