Company: APM
Filing Date: 2025-04-30
Form Type: 20-F
Source: 0001213900-25-037669
Chunk: 144

Company: Aptorum Group Ltd
Filing Date: 2025-04-30
Form: 20-F
Item: Item 4
Chunk 144
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 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.

Under the centralized procedure,
the Committee for Medicinal Products for Human Use, or the CHMP, established by the EMA is responsible for conducting the assessment of
a product to define its risk/benefit profile. Under the centralized procedure, the maximum timeframe for the evaluation of an MAA is 210
days, excluding clock stops when additional information or written or oral explanation is to be provided by the applicant in response
to questions of the CHMP. Accelerated evaluation may be granted by the CHMP in exceptional cases, when a medicinal product is of major
interest from the point of view of public health and, in particular, from the viewpoint of therapeutic innovation.

If the CHMP accepts such a
request, the time limit of 210 days will be reduced to 150 days, but it is possible that the CHMP may revert to the standard time limit
for the centralized procedure if it determines that it is no longer appropriate to conduct an accelerated assessment.

Periods of Authorization and Renewals

A marketing authorization
is valid for five years, in principle, and it may be renewed after five years on the basis of a reevaluation of the risk benefit balance
by the EMA or by the competent authority of the authorizing Member State. To that end, the marketing authorization holder must provide
the EMA or the competent authority with a consolidated version of the file in respect of quality, safety and efficacy, including all variations
introduced since the marketing authorization was granted, at least six months before the marketing authorization ceases to be valid. Once
renewed, the marketing authorization is valid for an unlimited period, unless the European Commission or