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GMP News No. 172
27 February 2002
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In December 2001 the three-year transition period of the MRA agreementbetween the EC and the USA expired. The purpose of this transition periodwas to allow time to confirm the equivalence of the inspection systems inorder to be able to do dispense with the need for reciprocal inspections.Whereas the EC evaluation of the American system is nearing completion,the FDA has only evaluated one EC member state, the United Kingdom, todate.
This means that the transition phase will have to be extended.
According to EMEA, the European regulatory authority, a plan is stillneeded as to how to proceed further in order to be able to consider anextension. Particularly since the EC demands a pledge from FDA that theevaluation of all the EC states will really be completed during theextended transition period. FDA is still hesitant in this regard since,according to Joseph C. Famulare of the Office of Compliance, CDER, MRAis only being processed as the internally available resources allow.
In the year 2000 the USA already published the sequence in which theother EC states were to be evaluated:
According to Famulare, the main reasons why the process is dragging somuch are translation problems and lack of resources. Famulare said thatthe paper review of the EC states would be delayed by months since most ofthe countries had submitted their documents in their national languages.The USA then returned the documents to the EC commission asking for themto be translated since they were not in a position to have the documentstranslated themselves. The EC Commission then assured the USA that atleast certain documents would be translated. Famulare said that jointaudits to confirm the inspection practice could not begin before the paperreview had been completed.
The FDA's suggestion of a "rolling implementation" ofindividual EC states by the USA was greeted by the Europeans with reservesince it contradicted the concept of a united Europe.
FDA responded to this with an interesting suggestion for speeding upthe procedure, an "interim step". The idea is for theparticipating states to exchange inspection reports already during thetransition phase. With the help of these inspection reports FDA coulddecide not to send any inspectors to the individual countries for jointaudits. This seems to be acceptable for the Europeans, too.
The expansion of the EU to include eastern European countries mightcause 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 thealready existing SOPs to permit an exchange of field alert reports. TheEuropeans, however, would rather complete the transition period first. Itwas extremely difficult to coordinate the currently valid SOPs within theEC.
What is more, at present the confirmation by the EC concerning thehandling of confidential commercial information is still pending.
A new aspect concerning the MRA agreement are the critical remarksof the US industry. They fear that the absence of FDA inspections inEurope upon completion of the transition period will lead to injusticesin the follow-up measures to inspections. There is also even the fearin some quarters that fewer pharmaceutical companies will be set up in theUSA.
The former head of the Office of Compliance, Stephanie Gray, has alsowarned of inequalities in the strictness of inspections in and outside ofthe USA.
The MRA agreement between the EC and Canada , which also becameeffective at the end of 1998, but which provided for a transition periodof only 18 months, has been all but forgotten. The operational phaseshould actually have started long ago, but here too commencement has beenpostponed to the end of 2002.
An MRA agreement between the EC and Switzerland is scheduled forratification in mid-2002.
Sources:Gold Sheet, October 2001
We must therefore continue to expect FDA audits in cases wherewe export to the USA. In order to prepare you for FDA's specialrequirements, we offer you the following Education Courses: