Company: APM
Filing Date: 2025-12-05
Form Type: 424B5
Source: 0001213900-25-118752
Chunk: 247

Company: Aptorum Group Ltd
Filing Date: 2025-12-05
Form: 424B5
Chunk 247
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 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 pediatric population, unless the EMA has granted a product-specific waiver, class waiver, or a deferral for
one or more of the measures included in the PIP.

The centralized procedure provides
for the grant of a single marketing authorization by the European Commission that is valid for all EU member states. Pursuant to Regulation
(EC) No. 726/2004,