Company: RVRC
Filing Date: 2025-12-12
Form Type: S-1/A
Source: 0001213900-25-121070
Chunk: 144

Company: Revium Rx.
Filing Date: 2025-12-12
Form: S-1/A
Chunk 144
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 been revised via the Windsor
Framework. Under the Windsor Framework, from January 1, 2025, all new medicinal products for the UK market will be authorized by
the UK’s Medicines and Healthcare products Regulatory Agency (“MHRA”) (see further below).

In the UK, clinical trials of medicinal products
are primarily governed by the Medicines for Human Use (Clinical Trials) Regulations 2004, as amended (the UK Regulations). The UK
Regulations sought to implement the CTD while the UK was a member state of the EU. 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