Company: APM
Filing Date: 2025-07-15
Form Type: DRS
Source: 0001213900-25-063899
Chunk: 226

Company: Aptorum Group Ltd
Filing Date: 2025-07-15
Form: DRS
Chunk 226
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 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, 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, including products for the treatment of cancer. For products with a new active
substance indicated for the treatment of other diseases and products that are highly innovative or for which a centralized process is
in the interest of patients, the centralized procedure may be optional.

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