Company: RVRC
Filing Date: 2025-10-03
Form Type: S-1/A
Source: 0001213900-25-096094
Chunk: 145

Company: Revium Rx.
Filing Date: 2025-10-03
Form: S-1/A
Chunk 145
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 market any medicinal product outside
of the United States, a company must also comply with numerous and varying regulatory requirements to generate relevant data for the purpose
of establishing its quality, safety and efficacy. There are specific rules governing, among other things, clinical trials, marketing authorization,
commercial sales and distribution of products. Regardless of the product approval status in the United States, an applicant will need
to obtain the necessary approvals granted by the comparable foreign regulatory authorities before it can commence clinical trials or marketing
of a medicinal product in those countries or jurisdictions.

The processes governing approval of medicinal
products in the EU and UK generally adopt a similar approach to that applied in the United States. They entail satisfactory completion
of preclinical studies and adequate and well-controlled clinical trials to establish the safety and efficacy of the product for each proposed
indication. Data should be generated to demonstrate that a drug substance and a drug product can be manufactured and controlled according
to the pre-specified quality standards. The data relating to quality, preclinical testing and clinical trials should be submitted to the
relevant competent authorities in a marketing authorization application (“MAA”) for regulatory review in order to determine
whether a marketing authorization can be granted. Even if a marketing authorization has been granted, there is a need to obtain a pricing
and reimbursement decision before a new medicinal product can be marketed and sold in the EU and/or the UK (as applicable).

Clinical Trial Approval

Pursuant to the currently applicable Regulation
(EU) No 536/2014 (CTR) and Directive 2005/28/EC on GCP, an applicant must obtain approval from the national competent authority of an
EU member state in which the clinical trial is to be conducted, or in multiple member states if the clinical trial is to be conducted
in a number of member states. Furthermore, the applicant can only start a clinical trial at a specific site after a research ethics committee
has issued a favorable opinion. The clinical trial application must be accompanied by an investigational medicinal product dossier with
supporting information prescribed by the CTR and corresponding national laws of the member states. All suspected unexpected serious adverse
reactions to the investigational medicinal product that occur during the clinical trial have to be reported to the national competent
authorities and research ethics committees of the member state where they occurred.

Pursuant to the CTR, a sponsor must submit
a single application for a new clinical trial authorization through a centralized EU clinical trials portal called the Clinical Trials
Information System (“CTIS”). One