Company: CSCIF
Filing Date: 2025-04-09
Form Type: 20-F
Source: 0001641172-25-003456
Chunk: 55

Company: COSCIENS Biopharma Inc.
Filing Date: 2025-04-09
Form: 20-F
Item: Item 5
Chunk 55
---
 In Canada, the Therapeutic Products
Directorate of Health Canada is the Canadian federal authority that regulates pharmaceutical drugs and medical devices for human use.
Prior to being given market authorization, a sponsor must present substantive scientific evidence of a product’s safety, efficacy,
and quality as required by the Food and Drugs Act and other legislation and regulations. The requirements for the development and sale
of pharmaceutical drugs in Canada are substantially similar to those in the U. S., which are described above.

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The European Union. Medicines can be authorized
in the EU by using either the centralized authorization procedure (CP), or national authorization procedures. The EU has implemented
a centralized procedure coordinated by the EMA for the approval of human medicines, which results in a single marketing authorization
issued by the EC that is valid across the EU, as well as Iceland, Liechtenstein, and Norway. The centralized procedure is mandatory for
human medicinal products containing a new active substance for the treatment of HIV/AIDS, cancer, diabetes, neurodegenerative diseases,
autoimmune diseases, other immune dysfunctions, viral diseases, or that are designated as orphan medicinal products. In addition, the
CP is required for product types derived, for example, from biotechnological processes or genetic engineering. For medicines that do
not fall within these categories, an applicant has the option of submitting an application for a centralized marketing authorization
to the EMA, as long as the medicine concerned is a significant therapeutic, scientific or technical innovation, or if its authorization
would be in the interest of public health.

There are two national routes to authorize medicinal
products in several EU countries, which are available for investigational drug products that fall outside the scope of the centralized
procedure and result in a national marketing authorization:

  Decentralized procedure. Using the decentralized procedure, a sponsor                                                                      
  may apply for simultaneous authorization in more than one EU country of medicinal products that have not yet been authorized in any        
  EU country and that do not fall within the mandatory scope of the centralized procedure. After mutual approval national authorizations     
  will be granted separately by each member state involved. Mutual recognition procedure. In the mutual recognition procedure, a medicine    
  is first authorized in one EU Member State, in accordance with the national procedures of that country. Following this, further marketing  
  authorizations can be sought from other EU countries in a procedure whereby the countries concerned agree to recognize the validity        
  of the original, national marketing authorization.                                                                                         
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