Company: BLRX
Filing Date: 2025-03-31
Form Type: 20-F
Source: 0001178913-25-001123
Chunk: 86

Company: BioLineRx Ltd.
Filing Date: 2025-03-31
Form: 20-F
Item: Item 3
Chunk 86
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 of the product. Some
products are never approved. In recent years, there has been a trend towards shorter regulatory review times in the United States as well
as certain European countries, despite increased regulation and higher quality, safety and efficacy standards.

Historically, different requirements by different countries’
regulatory authorities have influenced the submission of applications. However, a trend toward harmonization of drug and medical device
approval standards, starting in individual countries in Europe and then in the EU as a whole, in Japan, the United Kingdom and in the
United States under the aegis of what is now known as the International Council on Harmonisation, or ICH (created as the International
Conference on Harmonisation in 1990), is gradually narrowing these differences. In many cases, compliance with ICH standards can help
avoid duplication of non-clinical and clinical trials and enable companies to use the same basis for submissions to each of the respective
regulatory authorities. The adoption of the Common Technical Document format by the ICH has greatly facilitated use of a single regulatory
submission for seeking approval in the ICH regions and many other countries worldwide.

Summaries of the United States, EU, United Kingdom and Israeli
regulatory processes follow below.

47

United States

In the United States, drugs are subject to rigorous regulation
by the FDA. The U. S. Federal Food, Drug and Cosmetic Act, or FDCA, and other federal and state statutes and regulations govern, among
other things, the research, development, testing, manufacture, storage, record-keeping, packaging, labeling, adverse event reporting,
advertising, promotion, marketing, distribution and import and export of pharmaceutical products. Failure to comply with the applicable
U. S. requirements may subject us to stringent administrative or judicial sanctions, such as agency refusal to approve pending applications,
warning letters, product recalls, product seizures, total or partial suspension of production or distribution, injunctions or criminal
prosecution.

Unless a drug is exempt from the NDA process or the Biologics License
Application, or BLA, process or subject to another regulatory procedure, the steps required before a drug may be marketed in the United
States include:

  preclinical laboratory tests, animal studies and formulation development;  

  submission to the FDA of an Investigational New Drug, or IND, application to conduct human clinical testing;  

  adequate and well controlled clinical trials to determine the safety and efficacy of the drug for each indication as well as to establish  

  submission to