Seven years after launching the PRIME (PRIority MEdicines) scheme, the European Medicines Agency (EMA) has made several significant changes aimed at strengthening support for the development of life-changing medicines.
The changes follow a five-year review that looked at ways to improve the scheme. One of the biggest advances is the introduction of a roadmap, which includes an excel file that innovator companies can use to compile information, as well as a product development tracker. The tools aim to support ongoing discussions between developers and regulators.
In addition, as part of a 12-month pilot, the PRIME scheme will offer expedited scientific advice. Regulators will also offer submission readiness meetings a year ahead of submitting a marketing authorization application.
The earlier assessment of submission readiness will also be documented within the roadmap, giving developers a better understanding of the process and greater assurance that their approach is in line with requirements.
The new features address the lack of sufficient tools and support needed for the innovation and development process. Undoubtedly, EMA’s experience with fast-track or rolling submissions to support the COVID-19 vaccines gave the agency greater insight into the types of tools and features that would assist with the development and approval of life-saving medicines.
In the latest update to its Regulatory Science Strategy to 2025 (mid-point achievements to end 2022), the agency highlighted the importance of promoting and investing in the PRIME scheme. Priorities include improving communication to better explain and promote the scheme, enabling greater flexibility and opportunities for more seamless discussions, finding ways to shorten the development and review process, exploring further engagement with key stakeholders, and considering expanding early entry to the scheme to more applicants.
The changes bring PRIME into closer alignment with the UK’s Innovation Licensing and Access Pathway (ILAP) from the Medicines and Healthcare products Regulatory Agency (MHRA). Since it was initiated in 2021, ILAP has provided tools that support companies throughout the process, “including facilitating the development of alternative clinical protocols and facilitating patient recruitment via a centralized search of health records databases”, Francesco Lanucara of Biopharma Excellence has previously noted.
ILAP has more closely mirrored the FDA Fast Track process, which enables rolling reviews and allows applicants to submit completed sections for review rather than waiting until the entire application is complete.
With the changes to PRIME, developers can expect a more transparent, easier process and the hope is that patients will have earlier access to life-changing treatments. Ultimately, these changes will help to drive greater harmonization across the major markets with regard to scientific advice and regulatory support for innovative products.