TTIP – EU/US make progress on generics and biosimilars
The EU repeated its interest in working towards aligned rules naming and labelling biosimilars
Negotiators continue to make solid progress in the talks to forge a Transatlantic Trade & Investment Partnership (TTIP) trade deal between the US and the European Union (EU) that includes regulatory harmonisation and mutual recognition of pharmaceutical rules.
Detailed progress reports issued by the European Commission have noted discussions which took place from 14–23 October in Miami and Washington.
Brussels said it would submit before the February 2016 round of talks in Brussels, a technical paper identifying opportunities for further collaboration and harmonisation on authorising generic medicines.
The EU also welcomed new and final US guidance on biosimilars; the EU repeated its interest in working towards aligned rules naming and labelling biosimilars.
Discussions will continue on establishing a system for exchanging confidential information (including trade secrets) between regulators. And future rounds of discussions will focus on parallel scientific advice by EMA and the FDA; plus authorising paediatric medicines, including transparency on pricing and reimbursement.
Meanwhile, a task force of EU and US regulators from the European Commission, the European Medicines Agency and the US Food & Drug Administration has continued to assess equivalence of EU and US GMP inspection systems.