According to a document made public last month, during talks in April EU officials put forward the idea that, rather than conducting duplicate inspections, US regulators could accept good manufacturing practice (GMP) compliance certificates issued by the EMA and vice versa.
They also suggested certificates issued to manufacturing facilities outside Europe and the US be accepted as proof a plant is up to code by the issuing regulator’s counterpart on the opposite side of the Atlantic.
To facilitate such mutual recognition the EU team suggested EMA and FDA drug approval requirements would need to be more closely aligned – everything from preclinical testing through to production – adding that guidelines would need to be developed in collaboration.
What is TTIP?
The Transatlantic Trade and Investment Partnership is a free trade agreement being negotiated between the EU and US. It will open up their export markets, eliminating all tariffs and other barriers on trade for pharmaceuticals, among other products.
It will also standardise many regulations, and – a sticking point for many dissenters – enforce very strong IP protection.
13 rounds of negotiation have taken place so far, with implementation expected by the end of the year
Industry calls
The comments about regulatory alignment fit with what Eli Lilly’s President of Biomedicines, Dave Ricks, called for at BIO 2015.
He told attendees at the industry conference TTIP was needed "to force regulators to cooperate."
The EMA and US FDA have "entrenched positions" on scientific advice which often differ, such as which comparators to use in trials or the rules on conducting clinical trials on children. The differences force pharma companies to repeat studies, wasting time and money and delaying development, he said.
Novo Nordisk’s Head of Corporate Government Affairs Morten Pedersen, also speaking at BIO last year, said TTIP will synchronise regulations for manufacturing as well as trials.
Under the agreement, FDA and EMA will not need to duplicate each others' inspections of pharmaceutical facilities, as "visits several weeks apart add no extra value and it is better to free up resources," he said.
The EMA which previously told us it supported the TTIP proposals has been exploring the idea of supplier inspection databases since April 2015 as part of its network 2020 strategy.
Wishful thinking
But a facility inspection expert we asked said at this stage the idea is "wishful thinking" and added that the regulatory harmonization required would be a significant challenge for the EMA and FDA.
"The real work concerning the details - article 7 inspections - is referred to as to be ‘set out in Annex XX . . .' but this will be the most difficult work to agree upon considering the different history of GMPs in both regions."
He also said differences in inspection processes and priorities in Europe and the US would also need to be taken into account.
The 14th round of the TTIP negotiations is due to take place next month.