US/EU agree pharma deal

23 June 1997 00:00  [Source: ICB]

Terms of a mutual recognition agreement (MRA)have finally been agreed between the European Union and the US. The agreement will be fully implemented for pharmaceuticals within three years.

The move should reduce costs and shorten delays in trade between the EU and the US. When fully implemented, the agreement will recognise the results of product testing or certification requirements set by both governments, eliminating the need for duplicative testing, inspection and certification requirements.

'Under this landmark agreement US regulatory agencies, for the first time, have entered into a cooperative international agreement that strives to reduce regulatory costs while at the same time seeks to expand market access and protect the health and safety of consumers on both sides of the Atlantic,' said US Commerce Secretary William Daley.

The agreement was concluded with the support of the Transatlantic Business Dialogue (TABD) an initiative set up by EU and US governments in association with industry.

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