Posted 22 February 2017
By Zachary Brennan
A deal to further harmonize and mutually recognize good manufacturing practice (GMP) inspections between the US and EU will not be delayed, as the EU ambassador to the US said Wednesday that the Transatlantic Trade and Investment Partnership (TTIP) is in a state of pause as there is no one within President Donald Trump’s administration with whom to continue discussions.
Despite the TTIP pause, a spokesman from the EU ambassador told Focus via email on Thursday evening that there is no delay in the GMP harmonization pact between the US and EU, meaning the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) could soon have a deal to mutually recognize GMP inspections.
In October, a report on the 15th round of TTIP negotiations said negotiations were progressing and a GMP mutual recognition deal was expected by January.
"TTIP is neither alive nor dead," EU ambassador to the US David O'Sullivan said in a speech at the International Institute for Strategic Studies Wednesday. "It’s paused for the moment…We stand ready to continue the discussions, if that is not [the Trump administration's] wish, we will see what they say."
And the most recent report on those negotiations from 17 January did indicate that a deal had been forged: “In the pharmaceutical sector, for example, we made substantial progress towards updating our mutual recognition agreement on good manufacturing practices (GMP) inspections, which would reduce duplicative requirements on manufacturers of pharmaceutical products and allow regulators to allocate resources more efficiently and where they are most needed, benefitting public health.
A major sticking point for both FDA and EMA is the question of trade secret information (inspections typically involve specifications of manufacturing equipment and processes for manufacturing drugs that are proprietary information).
Beyond the mutual recognition of GMP inspections, the EU said previously that there are a number of matters still to be agreed upon/discussed, particularly on the scope and implementation.
"For some provisions, first attempts of common language have been discussed. The EU raised in particular its Article 4 and 5 on collaboration in international organisations and implementation of international standards and Article 6.1 on medicinal products authorisation. Other issues discussed include the scope and definitions, the exchange of confidential information between regulators and the regulatory cooperation as well as the US proposals not covered in the EU text," the 15th round report says.
The EU stressed the need for collaboration on antimicrobial resistance and reiterated its interest in including veterinary products in the scope of the pharmaceutical text.
Currently, EMA has mutual recognition GMP agreements in place with Switzerland, Australia, New Zealand, Japan, Canada (with some limitations) and Israel (with some exclusions).