EMA: New pathways and Ebola vaccines can help expedite approvals

In March this year​ the European Medicines Agency invited companies to participate in a pilot project on a new adaptive approval approach aimed to speed up the licensing times of certain drugs and improve patient access.

The approach builds on regulatory processes already in place - including scientific and compassionate use, pharmacovigilance tools that allow collection of real-life data – and will allow early authorisation of a medicine in a restricted patient population for treatments of serious conditions where there is an unmet medical need.

According to Senior Medical Officer at the EMA Dr Hans-Georg Eichler, is part of a series of changes at the agency to help balance its role as “gatekeeper and enabler.”​

Eichler was speaking at the FT Global Healthcare and Biotech Conference in London, UK on Monday where he told delegates that for pharma “the entire business model is underpinned by regulation,”​ differentiating it from other industries and leading to increased costs and slower development for drugmakers.

“The adaptive pathway was in response to demands from industry and patient groups to address the conundrum between timely access and sufficient evidence,”​ he said. “We are caught between a rock and hard place as whatever we do as a regulator we will always be criticised either from the left or from the right, and has happened for years.”​

The new pathway will satisfy the greatest medical need, simultaneously allowing continuous development, observation and growth of knowledge for not just the agency but industry and the payers, Eichler said, adding he hopes this will build further on the guidance introduced in 2009​ for novel drug development methodologies that aims to provide qualification advice on innovative methods and drug development tools, and “address the inefficiency in the research space.”​

Learn from Ebola​

As drugmakers look to expedite vaccines and treatments for the Ebola virus sweeping through West Africa, GSK’s CEO Sir Andrew Witty recently said: “We are literally doing in maybe five or six months what would normally take five or six years.”​

Eichler said that in 2009 a vaccine had been sped through development to deal with the outbreak of Swine Flu but, but when asked why such expedited development cannot be applied more generally he was unable to say whether this is the harbinger of things to come.

“If the drug is out the door then the worst thing that could happen is that we learn nothing. What has to be in place is a rapidly learning healthcare system [to benefit from this exceptional vaccine development],”​ he said, making use of as much data as possible.