Company: APM
Filing Date: 2025-07-15
Form Type: DRS
Source: 0001213900-25-063899
Chunk: 227

Company: Aptorum Group Ltd
Filing Date: 2025-07-15
Form: DRS
Chunk 227
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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 the competent authority decides,
on justified grounds relating to pharmacovigilance, to proceed with one additional five-year renewal period. Any authorization that is
not followed by the placement of the drug on the EU market (in the case of the centralized procedure) or on the market of the authorizing
Member State within three years after authorization ceases to be valid.

Regulatory Requirements after Marketing Authorization

Following approval, the holder
of the marketing authorization is required to comply with a range of requirements applicable to the manufacturing, marketing, promotion
and sale of the medicinal product. These include compliance with the EU’s stringent pharmacovigilance or safety reporting rules,
pursuant to which post-authorization studies and additional monitoring obligations can be imposed. In addition, the manufacturing of authorized
products, for which a separate manufacturer’s license is