US/Europe pharma licensing falls in line

06 February 1997 00:00  [Source: ICB]

Harmonisation of European and US drug licensing moved a step closer last week following talks on a joint pharmaceutical practice recognition agreement.

If, or when, the subsequent licensing agreements are met it could lead to a cut in the time and money spent on clinical tests by pharma-companies trying to meet approval of tough US Food and Drug Administration standards.

Although the Mutual Recognition Agreement (MRA) on drug manufacture, discussed at the EU/US summit meeting in Paris, is yet to be signed, participants say they are confident it will be.

President of the European Commission Jacques Santer applauded the talks, adding in a statement: 'We have seen good progress in our negotiations on the MRA which will bring enormous trade benefits to both sides. We hope to conclude the agreement within the next few days.'

A spokesman for Glaxo Wellcome said: 'We believe it will have significant benefits in reducing duplication of regulation. We have been involved in discussions with the European Union and the US authorities to enter into it.'

A spokesman for the Association of the British Pharmaceutical Industry welcomed the licensing, adding: 'It is not yet signed - until the ink is on the blotting paper we cannot be sure but it is looking good. It means they will accept our licensing and we will accept theirs - there will be no need for double inspections.'

But a spokeswoman for the European Federation of Pharmaceutical Industry Associations was more sceptical, saying that talks were welcome but only provided that the European position was fully represented. 'We hope for an agreement but not one at any price. We want our position considered.'

Also contained in the talks was the Chemical Precursor Agreement which is designed to curb the diversion of chemicals used in the manufacture of illicit drugs. Leon Brittan, the vice president of the European Commission, and his US counterpart at the meeting Charlene Barshefsky are expected to sign the agreement by the 11 June deadline.

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