EMA/ FDA Mutual Recognition Agreement moving forward
A possible agreement between the European Medicines Agency EMA and
the US Food and Drug Administration FDA on mutual recognition of drug facility
inspections could already be signed in January 2017. This is noted in a
report of the EU Commission: "The state-of-play and the organisation of
the evaluation of the US and the EU GMP inspectorates were discussed. In light
of the progress achieved, the conclusion of a mutual recognition agreement of
Good Manufacturing Practices (GMPs) inspections by January 2017 is under
consideration."
But, according to the Commission, some issues are still not
resolved - like, for example, the exchange of confidential information and
the inclusion of veterinary products in the scope of the text.
The
"Report of the 15th Round of
Negotations for the Transatlantic Trade and Invesment Partnership" summaries the 15th
round of negotiations for the Transatlantic Trade and Investment Partnership
(TTIP) from 3rd to 7th October 2016 in New York.
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