Company: RVRC
Filing Date: 2025-08-13
Form Type: S-1/A
Source: 0001213900-25-075747
Chunk: 136

Company: Revium Rx.
Filing Date: 2025-08-13
Form: S-1/A
Chunk 136
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 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 national competent authority (from the reporting EU member state selected by the applicant)
takes the lead in validating and evaluating the application, as well as consulting and coordinating with the other concerned member states
in which the clinical trial is to be conducted. If an application is rejected, it may be amended and resubmitted through CTIS. A concerned
member state may in limited circumstances declare an “opt-out” from an approval and prevent the clinical trial from being
conducted in that member state. By January 31, 2025, all ongoing trials approved under the CTD must comply with the CTR and information
relating to such clinical trials must be recorded in CTIS. The CTR aims to streamline and simplify the rules on safety reporting, and