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INNOSC Theranostics and
Pharmacological Sciences Pediatric drug regulations in India

associated with filing a PPSR; however, sponsors who wish (a) Validation: up to 1 month
to complete WR as a component of a marketing proposal (b) Evaluation phase: 1 + 1 month
or supplementary application must supply the studies and (c) Conclusion phase: 40 days (which can be
pay any associated fees. shortened to 10 days upon the application).
7.4. When should the PIP, PSP, and PPSR be This creates a total of 190 days. However, during the
submitted? time between the first and second (obligatory) evaluation
phases, the sponsor has an infinite amount of time to reply
7.4.1. EU to the inquiries from the PDCO for modifications (referred
A PIP proposal has to be filed early in the medication to as the clock-stop period). Although the EMA suggests a
advancement procedure in the EU, usually after response time of 90 days, in practice, it typically lasts about
completing pharmacokinetic trials in adult individuals. 4.5 months.
The EMA accepts the sponsor’s ambiguity and specifies 7.5.2. US
that submissions must coincide with the conclusion of
pharmacokinetic study and preliminary tolerance research Under the US PSP evaluation guidelines, the first PSP
for healthy subjects or patients, or with the beginning of must be examined within 75 days after receipt, according
adult Phase II research (proof-of-concept), but not before to Pediatric Epilepsy Research Consortium regulation.
Phase III studies. Within 90 days of receiving the PSP, the FDA must hold
a meeting or provide the sponsor with a written answer.
7.4.2. US After the meeting with the FDA, the sponsor has 90
Under PREA, the sponsor is required to submit the first calendar days to submit an agreed initial PSP or to receive
PSP within 2 months following the conclusion of the phase written comments from the FDA. The FDA provides
II discussion in the US. The sponsor should submit the written confirmation of its agreement within 30 days after
first PSP as soon as possible, but before starting any phase the agreed initial PSP submission.
III investigations or combining phase II and III research, The review period for a PSP in the US would normally
if there is not an end-of-phase (EOP2) conference. The last 7 months, and the sponsor could begin the process as
sponsor must submit the first PSP application at least soon as 60 days following the EOP2 conference, according
7 months before submitting a marketing application or to the previously outlined protocol. Initiation should
supplementary if no phase III or combination phase II happen before beginning a phase III trial or a combined
and III studies will be completed. It is strongly advised to phase II and III trial (i.e., sooner) if an EOP2 conference is
send an initial PSP before the EOP2 meeting for serious not held. If not, initiation must take place up to 210 days
or fatal disorders with limited pediatric treatment options. before marketing application submission.
This will enable product discussions during the initial IND
stage or during the EOP2 meeting. 52 Regarding WRs in the US, the FDA may not respond
to the sponsor with a suitable answer for up to 120 days
7.5. Method of assessment following the submission of the PPSR.
7.5.1. EU 8. Pediatric drug regulations in China

In the EU, the method of assessment for PIP involves a The Drug Administration Law, which became effective
thorough evaluation and expert advice from the Pediatric on December 01, 2019, clearly outlines the nation’s
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Commission of the EMA. The final decision is made by responsibility to promote and prioritize the creation of
the EMA. The EMA reviews and validates proposed PIPs new forms, dosages, and precise information of pediatric
within 30 days and then provides a review analysis to the medications that align with children’s physiological
PDCO. After receiving a valid proposal, which is delivered characteristics. Regulatory agencies are in the process of
by EMA to sponsors within 10 days of adoption, the PDPC establishing guidelines, enhancing communication and
has 60 or 120 days to adopt its opinion. If there is no technical support, as well as securing high-quality resources
request for reexamination from sponsors within 30 days, for clinical trials related to pediatric drugs. The regulatory
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the advice becomes final and results in an EMA conclusion documents issued in China are represented in Table 4. We
on PIP issuance within a further 10 days. have received a comprehensive list of all oppositional defiant
The maximum review time that an evaluator agency disorders from 2000 up to December 2012 from EMA. This
can take includes: includes designation dates and numbers, indications, and
(i) A validation stage of up to 30 days age categories indicating whether they are intended for
(ii) A specific timeframe for the EMA to review a PIP: use in children or adults (i.e., potential pediatric usage or

Volume 7 Issue 4 (2024) 13 doi: 10.36922/itps.3831