Company: SXTPW
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001013762-25-003343
Chunk: 62

Company: 60 DEGREES PHARMACEUTICALS, INC.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1
Chunk 62
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2005/28/EC. Pursuant to Directive 2001/20/EC and Directive 2005/28/EC, as amended, a system for the approval of clinical trials in the
European Union has been implemented through national legislation of the E.U. member states. Under this system, approval must be obtained
from the competent national authority of each E.U. member state in which a study is planned to be conducted. To this end, a clinical
trial application is submitted, which must be supported by an investigational medicinal product dossier (“IMPD”), and further
supporting information prescribed by Directive 2001/20/EC and Directive 2005/28/EC and other applicable guidance documents. Furthermore,
a clinical trial may only be started after a competent Ethics Committee has issued a favorable opinion on the clinical trial application
in that country.

In April 2014, the European Union passed the
new Clinical Trials Regulation, (EU) No 536/2014, which will replace the current Clinical Trials Directive 2001/20/EC. To ensure that
the rules for clinical trials are identical throughout the European Union, the new E.U. clinical trials legislation was passed as a regulation
that is directly applicable in all E.U. member states. All clinical trials performed in the European Union are required to be conducted
in accordance with the Clinical Trials Directive 2001/20/EC until the new Clinical Trials Regulation (EU) No 536/2014 becomes applicable.
According to the current plans of EMA, the new Clinical Trials Regulation will become applicable in 2019. The Clinical Trials Directive
2001/20/EC will, however, still apply three years from the date of entry into application of the Clinical Trials Regulation to (i) clinical
trials applications submitted before the entry into application and (ii) clinical trials applications submitted within one year after
the entry into application if the sponsor opts for old system.

The new Clinical Trials Regulation aims to simplify
and streamline the approval of clinical trials in the European Union. The main characteristics of the regulation include: a streamlined
application procedure via a single entry point, the E.U. portal; a single set of documents to be prepared and submitted for the application
as well as simplified reporting procedures that will spare sponsors from submitting broadly identical information separately to various
bodies and different member states; a harmonized procedure for the assessment of applications for clinical trials, which is divided in
two parts-Part I is assessed jointly