Following our joint conference with the MHRA, and continuing our regulatory theme on the BIA blog this month, today’s post takes a closer look at how the European Medicines Agency’s PRIME scheme is comparing to US and Japanese initiatives.
The last session of the day took an in-depth look at a recent area of innovation in regulation for the EMA: the Priority Medicines scheme (PRIME), which was launched in March 2016.
Like the adaptive pathway approach, PRIME works within the existing regulatory framework to accelerate the delivery of drugs that address high unmet need.
Jordi Llinares, Head of the EMA’s Product Development Scientific Support Department, explained that the three pillars of PRIME are patients, support for R&D, and a pan-European approach. The aim of PRIME is to facilitate earlier scientific and regulatory advice, develop a robust data generation strategy, and thus enable accelerated assessment.
Once a potential therapy receives PRIME designation, a Rapporteur is appointed for products at proof of concept to guide the company through every stage of the process, including meetings with relevant committees to discuss development options and regulatory strategy. Iterative scientific advice is also given throughout and there are fee incentives for SMEs.
Jordi said that the scheme had been well-received, with 18 eligibility submissions in its first applications round, 11 of which were from SMEs. All were in scope and of sufficient detail for assessment, Jordi said, but there was a problem with too few submitting paediatric investigation plans (PIPs) or waivers. Although it is very early days for PRIME, its initial popularity shows industry’s need for such a scheme.
PRIME is modelled on the US Federal Drug Agency’s (FDA) breakthrough therapy designation, launched in 2012, and follows in the footsteps of the Japanese SAKIGAKE strategy launched in 2014. All three schemes aim to facilitate discussions between developers and regulators earlier in the process and provide a more hands-on approach from regulators throughout.
As PRIME is very much in its infancy, the BIA and MHRA invited Rhian Thomas, Executive Director, Global Regulatory Affairs, Amgen, to speak of her company’s experience gaining approval of Blincyto. Rhian told the conference that the breakthrough therapy designation was valuable but developers shouldn’t under-estimate how labour-intensive the process is.
In the panel Q&A session, Jordi said that the EMA will be exchanging notes with the FDA to compare their schemes and working practices to see what they could learn from each other. Robert Hemmings, member of the EMA’s Committee for Medicinal Products for Human Use (CHMP), who was also on the panel, noted that the FDA has already been stretched by the popularity of the breakthrough designation but that the EMA was confident it could meet demand. But he also sounded a word of caution; developers should not expect Europe to achieve the same acceleration as the US.