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INNOSC Theranostics and
Pharmacological Sciences Pediatric drug regulations in India

all pediatric subsets, such as full waivers, where a product The legal basis shares many similarities but is not
is subject to the following responsibilities. There are three entirely identical between both regions. For instance, the
established legal justifications: EU regulation does not explicitly permit waiving “highly
(i) If a certain medication or class of medications is impracticable” studies, as seen in rare or very rare diseases;
anticipated to be harmful or ineffectual for pediatric thus, lacking feasibility criteria within its legislation per se
patients compared to the US standards. Furthermore, unlike the
(ii) If the ailment for which the medication(s) is prescribed EU system, which does not grant waivers solely based on
solely affects adults (or only specific pediatric lack of meaningful therapeutic benefit unless there also is
subgroups); and not substantial usage among pediatric patients – contrary
(iii) If the medication(s) does not provide pediatric to what is applicable in the US regulatory framework. 44
patients with appreciable therapeutic advantages over
current therapies. 6.3. Deferrals
When conducting informative studies is impractical The deferral regulations are alike in both areas.
(for instance, in cases of incredibly rare illnesses in children
such as arrhythmia) or in situations when clinical trials 6.3.1. EU
employing the specific drug are unlikely to significantly A PIP that has been agreed upon may permit deferrals for
improve pediatric patient outcomes, the third legal basis part or all of the pediatric investigations and measures.
may be utilized to approve exemptions. Certain items or This means that after requesting a marketing license for
entire classes of medications may be exempt. Any exception adults for the same ailment, these studies may begin and/
can subsequently be changed or revoked if needed in light or end.
of breakthroughs in science and medicine. A waiver that is Deferrals need to have one of the following justifications:
changed or revoked will only become enforceable 3 years (i) Research involving children will take more time to
following the termination date.
complete than research involving adults
6.2.2. US (ii) Technological and scientific justification
(iii) When adult studies should be conducted before
The PREA gives the FDA the authority to disregard or omit beginning research on the pediatric group; and
the need for submitting a juvenile program under certain
conditions for specific age ranges. The FDA can grant (iv) Causes related to general health.
either whole or half waivers of this requirement upon its A precise completion deadline for the research must
initiatives or at an applicant’s proposal. If an applicant be chosen and agreed upon when a delay is granted. If the
seeks a waiver, they must furnish written justification and anticipated date of the adult marketing approval application
supporting evidence for their request. is postponed past the designated date of the pediatric study’s
The legal basis for such waivers is as follows: completion, the juvenile research might be due.
(i) If conducting necessary studies is not feasible or highly 6.3.2. US
impractical (for example, because there are very few
participants) While acknowledging the necessity of a pediatric
(ii) Should there be strong proof that the medication or evaluation, a deferral permits the candidate to provide the
biological substance will be harmful or useless for any research findings following the submission of a new drug
or all juvenile class application (NDA), BLA, or supplemental NDA or BLA.
The FDA may decide to postpone any or all of the pediatric
When a medication or biological substance: trials until a given time after the drug’s adult authorization
(a) does not significantly improve pediatrics’ current or the biologic’s licensing is issued.
therapy; and
(b) is not expected to be utilized by a significant The criteria for granting a deferral include:
number of individuals; (i) If the medication or biological item is ready for adult
authorization before juvenile research is finished
(iii) Furthermore, a waiver may be considered when it is (ii) If childhood studies must be delayed until more
impossible to develop a suitable pediatric formulation security or efficacy data are gathered; and
for certain age groups. If this situation arises, the (iii) If there is a different acceptable reason for deferring (such
waiver will only apply to those specific pediatric age as incomplete advancement of juvenile manufacturing).
groups requiring that particular formulation, with a
detailed explanation outlining why developing such a In both areas, though, economic reasons cannot be
formulation is unfeasible. used as a reason for postponement. 45

Volume 7 Issue 4 (2024) 8 doi: 10.36922/itps.3831