The PRIority Medicines Scheme (PRIME) of the European Medicines Agency (EMA) was started two years ago to support and optimise medicine development. The scheme provides early and enhanced scientific and regulatory support to medicines that have the potential to significantly address patients’ unmet medical needs. The EMA has published their two-year review and not surprisingly more than half of the applications are from small medium enterprises.
However, the jury is still out on the benefits of the PRIME scheme with 40% of applicants feeling that the follow-up after the kick-off meeting is inadequate. To keep this in perspective, a workshop on CAR T-cell therapy registries was recently held with attendance from all stakeholders. This early engagement enabled the group to not only explore in detail the opportunities and challenges of using the existing registries to support CAR T-cell therapy benefit-risk evaluations and post-authorisation follow up but also to align on a way forward.
A total of 177 requests for eligibility to the scheme have been received over a two-year period with 36 (21%) of these being accepted. It should be noted that the majority of these, in fact 83% were for rare diseases, a specialist area of work for Partners4Access.
What is proving beneficial for clients is early interaction with EU regulators. Developers of innovative or novel types of medicines and technologies are often presented with new scientific and regulatory challenges.
The first three marketing authorisation applications for medicines that were accepted for PRIME are all currently under evaluation with the first opinion expected later in 2018.
Partners4Access specialize in advising clients on market access of orphan and cell and gene therapies and diagnostics.
Further details on the announcement can be found at, http://www.ema.europ a.eu/docs/en_GB/document_library/Report/2018/05/WC500248828.pdf, however, If you require further advice with your market access strategy please get in touch at [email protected]
Author: Alison Kneen, Vice President International Operations
Email Alison at [email protected]