Company: RVRC
Filing Date: 2025-10-03
Form Type: S-1/A
Source: 0001213900-25-096094
Chunk: 147

Company: Revium Rx.
Filing Date: 2025-10-03
Form: S-1/A
Chunk 147
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. Since the CTR was not in force in the EU at the time
when the UK exited the EU, it was not retained in UK law on exit day under the terms of the European Union (Withdrawal) Act 2018. Following
a public consultation which was conducted in early 2022, the UK authorities are in the process of developing legislation which seeks to
improve and strengthen the clinical trials regulatory regime in the UK. The extent to which the regulation of clinical trials in the UK
will mirror the CTR is unknown at present.

Accelerated Assessment Pathways

The EU’s Priority Medicines (“PRIME”)
scheme is intended to encourage drug development in areas of unmet medical need and facilitates accelerated assessment of medicinal products
representing substantial innovation reviewed under the centralized procedure. Eligible products must target conditions for which there
is an unmet medical need (there is no satisfactory method of diagnosis, prevention or treatment in the EEA or, if there is, the new medicine
will bring a major therapeutic advantage) and they must demonstrate the potential to address the unmet medical need by, for example, introducing
new methods of therapy or improving existing ones. Products from small- and medium-sized enterprises may qualify for earlier entry into
the PRIME scheme. Many benefits accrue to sponsors of therapeutic candidates with PRIME designation, including but not limited to, early
and proactive regulatory dialogue with the EMA, frequent discussions on clinical trial designs and other development program elements,
and accelerated MAA assessment once a dossier has been submitted. Importantly, an EMA contact and rapporteur from the Committee for Human
Medicinal Products (“CHMP”), or Committee for Advanced Therapies are appointed early in the PRIME scheme facilitating increased
understanding of the product at the EMA’s Committee level. A kick-off meeting initiates these relationships and includes a team
of multidisciplinary experts at the EMA to provide guidance on the overall development and regulatory strategies. Where, during the course
of development, a medicine no longer meets the eligibility criteria, support under the PRIME scheme may be withdrawn.

The UK’s Innovative Licensing and Access
Pathway (“ILAP”) aims to accelerate the time to market of innovative medicinal products. It is open to both commercial and
non-commercial applicants, who are based in the UK or global, and who are developing medicinal products which include products containing
new chemical entities, biological medicinal products, new indications and repurposed medicinal products. It comprises of an Innovation