Company: SXTPW
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001013762-25-003343
Chunk: 60

Company: 60 DEGREES PHARMACEUTICALS, INC.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1
Chunk 60
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 design controls without providing
new data. When the modification involves a change in material, the nature of the “new” material will determine whether a
traditional or Special 510(k) is necessary.

30

Review and Approval of Drug Products
in the European Union 

In order to market any product outside of the
United States, a company must also comply with numerous and varying regulatory requirements of other countries and jurisdictions regarding
quality, safety and efficacy and governing, among other things, clinical trials, marketing authorization, commercial sales and distribution
of products. Whether or not it obtains FDA approval for a product, the company would need to obtain the necessary approvals by the comparable
foreign regulatory authorities before it can commence clinical trials or marketing of the product in those countries or jurisdictions.
The approval process ultimately varies between countries and jurisdictions and can involve additional product testing and additional
administrative review periods. The time required to obtain approval in other countries and jurisdictions might differ from and be longer
than that required to obtain FDA approval. Regulatory approval in one country or jurisdiction does not ensure regulatory approval in
another, but a failure or delay in obtaining regulatory approval in one country or jurisdiction may negatively impact the regulatory
process in others.

Procedures Governing Approval of Drug
Products in the European Union 

Pursuant to the European Clinical Trials Directive,
a system for the approval of clinical trials in the European Union has been implemented through national legislation of the member states.
Under this system, an applicant must obtain approval from the competent national authority of an E.U. member state in which the clinical
trial is to be conducted. Furthermore, the applicant may only start a clinical trial after a competent Ethics Committee has issued a
favorable opinion. Clinical trial application must be accompanied by an investigational medicinal product dossier with supporting information
prescribed by the European Clinical Trials Directive and corresponding national laws of the member states and further detailed in applicable
guidance documents.

To obtain marketing approval of a product under
European Union regulatory systems, an applicant must submit a marketing authorization application (“MAA”), either under a
centralized or decentralized procedure. The centralized procedure provides for the grant of a single marketing authorization by the European
Commission that is valid for all E.U. member states. The centralized procedure is compulsory for specific products, including for medicines
produced by certain biotechnological processes, products designated as orphan medicinal products, advanced therapy products and products
with a new active substance indicated for the treatment of certain diseases. For products with a new active substance indicated for the