Company: BLRX
Filing Date: 2025-03-31
Form Type: 20-F
Source: 0001178913-25-001123
Chunk: 93

Company: BioLineRx Ltd.
Filing Date: 2025-03-31
Form: 20-F
Item: Item 3
Chunk 93
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, the CTR has immediate effect for the whole EU and did not have to be transposed into national law. While national
laws implementing the CTD varied to a great extent, the CTR provides for a significant further harmonization of the law governing clinical
trials in the EU. After significant delay, the CTR became applicable on January 31, 2022. The CTR now harmonizes the assessment and supervision
processes for clinical trials throughout the EU via the Clinical Trials Information System (CTIS), which includes a centralized EU portal
and database for clinical trials. From 31 January 2023 onwards, clinical trial sponsors need to apply to start a clinical trial via CTIS.
From 31 January 2025, any trials previously approved under the CTD that continue to run after such date will need to comply with CTR and
their sponsors must have recorded the required information on such trials in CTIS. The CTR provides inter alia:

  Consistent rules for conducting clinical trials throughout the EU;  

  Making information on the authorization, conduct and results of each clinical trial carried out in the EU publicly available;  

  Harmonized electronic submission and assessment process for clinical trials conducted in multiple member states;  

  Improved collaboration, information sharing and decision-making between and within member states;  

  Increased transparency of information on clinical trials; and  
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  Higher standards of safety for all participants in EU clinical trials.  

The authorization of a clinical trial (Phase 1-3) in an EU member
state requires the submission of a clinical trial application (CTA) via the EU Portal, CTIS. The application will be reviewed by the competent
authorities of the member states where the trial is supposed to take place. The application and approval process is conducted by the member
states under the cooperation system set forth in the CTR. Particularities under member states’ national law still apply to some
extent. In general, the CTA should include, among other documents, the study protocol, results of the nonclinical studies and manufacturing
information and analytical results. Also, the sponsor has to suggest one of the concerned member states as reporting member state. The
CTR aims at speeding up the validation and review of clinical trial applications and therefore provides strict deadlines.

Marketing Authorization Procedures

A medicinal product may only be placed on the market in the EEA
if it has obtained a marketing authorization according to the applicable EU and/or member state law