EMA to help priority medicines reach the market faster

The priority medicines (PRIME) scheme will offer a fast-track channel for the development and marketing authorisation of medicines where "early clinical data" shows that they have the "potential to benefit patients with unmet medical needs", the EMA said.

EU health commissioner Vytenis Andriukaitis said PRIME has the potential to support "earlier access to safe treatments" for patients with "rare cancers, Alzheimer’s disease and other dementias", as well as "to accelerate the development and authorisation of new classes of antibiotics or their alternatives in an era of increasing antimicrobial resistance".

Through PRIME, drug manufacturers can get access to support from the EMA and scientific advice from other stakeholders, including health technology assessment bodies, at an early stage of a drug's development to shape how eligible drugs are developed, the EMA said. It said the scheme would help manufacturers to build up the bank of data they need to support the case for those drugs to win marketing authorisation and that the decision on whether to allow drugs to be brought to market would be made through an accelerated assessment process.

"Our goal is to foster better planning of medicine development to help companies generate the high quality data we need to assess quality, safety and efficacy of medicines," professor Guido Rasi, the EMA’s executive director, said. "Patients with no or insufficient treatments could then benefit from scientific progress and cutting edge medicines as soon as possible."

Expert in life sciences Helen Cline of Pinsent Masons, the law firm behind Out-Law.com, said that the assistance offered and the early dialogue encouraged under the scheme aims to help companies to use the existing regulatory mechanisms and avoid costly delays in the development of innovative new drugs while also giving patients the opportunity to have earlier access to these drugs.

"While PRIME builds on the existing regulatory framework, a move away from what used to be standalone business approaches and interests including open innovation approaches to drug discovery and advancements in data analytics and digitalisation, allowing patient self-reporting, are helping to facilitate these moves to a more streamlined and flexible regulatory process and more efficient and cost effective drug development," Cline said.