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News about GMP/cGMP


US/EU-Negotiations on GMP Inspections

In October, the 15th round of negotiations for TTIP (Transatlantic Trade and Investment Partnership) took place in New York. The European Commission has now published a report, which covers inter alia the mutual recognition of US/EU-GMP-inspections.


The  state of play and the organisation of the evaluation of the US and  the EU GMP inspectorates were discussed:

  • Both parties agreed that due to the progress achieved so far, the conclusion of a mutual recognition agreement (MRA) of GMP inspections by January 2017 is under consideration.
  • Audits of twelve additional EU countries are planned by the FDA in 2017.
  • The question of trade secret information is still up.

Beyond the MRA of GMP inspections, the harmonization in other areas was discussed. One of them is the EU proposal for an annex on medical devices. The EU and the US proposals for an annex on medical  devices have been put side by side in order to identify commonalities. For some provisions, notably the unique device identification, the regulated product  submission and the single audit first attempts  of common language have been discussed. In addition, the EU provided an update on the state of play of its new medical device regulations.


EC: Trade – TTIP. 15th negotiation round

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