With the increasing acknowledgement of the need to develop an overarching scheme to enhance support for sponsors developing medicines, tackling unmet medical needs to ensure timely access to beneficial therapies, the EMA launched the PRIME scheme in March 2016.
This scheme was designed to build upon the existing regulatory framework supporting faster access to new medicines where they are urgently required. PRIME is a voluntary scheme for medicines not authorised in the EU and can aid in the optimisation of the clinical development programme to support an expedited review process. This enables earlier patient access across the EU (early appointment of a Rapporteur, continuous support ahead of an MAA, accelerated MAA assessment, parallel EMA/HTA advice etc.).
In April 2014, two years prior to the introduction of PRIME, the Early Access to Medicines Scheme (EAMS) was launched in the UK. EAMS is a mechanism enabling early patient access in the UK to important medicines targeted for the treatment, diagnosis or prevention of seriously debilitating or life threatening conditions, prior to submitting a full marketing authorisation.
The PIM designation, which represents step I of the EAMS, provides sponsors with an opportunity to interact with regulators and receive validation of a product earlier in clinical development. Importantly, a PIM designation indicates that the UK Regulatory Agency, the MHRA, considers the product to be a promising candidate for entry into stage II of EAMS, where the sponsor has the opportunity to receive advice related to the clinical development programme from the MHRA and NICE / SMC, and the possibility to make the product available to patients in UK.
To discuss this further and learn more about Kinesys Consulting’s considerable experience with PRIME & EAMS / PIM applications, meet us at EuroMeeting 2017.
To schedule a meeting, please contact us at firstname.lastname@example.org or call our Glasgow office at +44 141 582 1211.
To Access the DIA EuroMeeting 2017 Program, click: here