Company: APM
Filing Date: 2025-04-30
Form Type: 20-F
Source: 0001213900-25-037669
Chunk: 143

Company: Aptorum Group Ltd
Filing Date: 2025-04-30
Form: 20-F
Item: Item 4
Chunk 143
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 these authorities before the product can be marketed and sold in the EU.

Clinical Trial Approval

Pursuant to the currently
applicable Clinical Trials Directive 2001/20/EC and the Directive 2005/28/EC on cGCP, a system for the approval of clinical trials in
the EU (the equivalent of the IND process in the United States) has been implemented through national legislation of the EU member states.
Under this system, an applicant must obtain approval from the competent national authority of an EU member state in which the clinical
trial is to be conducted or in multiple EU member states if the clinical trial is to be conducted in a number of EU member states. Furthermore,
the applicant may only start a clinical trial at a specific study site after the independent ethics committee has issued a favorable opinion.
The clinical trial application, or CTA, must be accompanied by an investigational medicinal product dossier with supporting information
prescribed by Directive 2001/20/EC and Directive 2005/28/EC and corresponding national laws of the EU member states and further detailed
in applicable guidance documents.

In April 2014, the EU adopted
a new Clinical Trials Regulation (EU) No 536/2014, which is set to replace the current Clinical Trials Directive 2001/20/EC. It is expected
that the new Clinical Trials Regulation will apply in 2019. It will overhaul the current system of approvals for clinical trials in the
EU. Specifically, the new regulation, which will be directly applicable in all EU member states, aims at simplifying and streamlining
the approval of clinical trials in the EU. For instance, the new Clinical Trials Regulation provides for a streamlined application procedure
using a single entry point and strictly defined deadlines for the assessment of clinical trial applications.

Marketing Authorization

To obtain a marketing authorization
for a product under the EU regulatory system (the equivalent of the NDA process in the United States), an applicant must submit an MAA,
either under a centralized procedure administered by the EMA or one of the procedures administered by competent authorities in EU member
states (decentralized procedure, national procedure, or mutual recognition procedure). A marketing authorization may be granted only to
an applicant established in the EU. Regulation (EC) No. 1901/2006 provides that prior to obtaining a marketing authorization in the EU,
an applicant must demonstrate compliance with all measures included in an EMA-approved Pediatric Investigation Plan, or PIP, covering
all subsets of the