Company: BLRX
Filing Date: 2025-03-31
Form Type: 20-F
Source: 0001178913-25-001123
Chunk: 92

Company: BioLineRx Ltd.
Filing Date: 2025-03-31
Form: 20-F
Item: Item 3
Chunk 92
---
 recovered from product sales in the United States, upon request of a
sponsor. This status is referred to as orphan designation (or sometimes “orphan status”). For a therapeutic candidate to qualify
for orphan designation, both the candidate and the disease or condition must meet certain criteria specified in the ODA’s implementing
regulations (set forth at 21 CFR Part 316). Orphan designation qualifies the sponsor of the candidate for various development incentives
of the ODA, including tax credits for qualified clinical testing, waiver of NDA/BLA user fees and eligibility for seven-year marketing
exclusivity, referred to as orphan exclusivity upon marketing approval. The granting of an orphan designation request does not alter the
standard regulatory requirements and process for obtaining marketing approval. Safety and effectiveness of a candidate must still be established
through adequate and well-controlled studies.

Expedited Programs for Serious Conditions

The FDA has put in place four programs intended to facilitate and
expedite development and review of a new drug intended to address an unmet medical need in the treatment of a serious or life-threatening
condition: fast track designation, breakthrough therapy designation, accelerated approval and priority review designation. Each program
offers the sponsor a defined set of opportunities such as expedited development and review, intensive FDA guidance during development,
marketing approval based on an effect on a surrogate endpoint or an intermediate clinical endpoint that is reasonably likely to predict
the drug’s clinical benefit, and a shorter time for review of marketing application. Fast Track and Breakthrough Therapy designations
may be requested during development, while Accelerated Approval and Priority Review relate to the marketing approval stage.

50

European
Union/European Economic Area

Clinical Trials

Within the European Union (EU) and the European Economic Area (EEA),
which is composed of the 27 member states of the EU plus Norway, Iceland and Liechtenstein, the authorization of clinical trials
occurs at member state level. The European Medicines Agency, or EMA, plays a key role in ensuring that GCP standards are applied across
the European Economic Area, or EEA, in cooperation with the member states. It also manages a database of clinical trials carried out in
the EU.

Clinical trials in the EU are regulated under Regulation (EU) 536/2014
(CTR), as amended on April 5, 2022. As opposed to the previous Directive 2001/20/EC (CTD), which as an EU directive was not directly applicable
in the member states