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INNOSC Theranostics and
Pharmacological Sciences Pediatric drug regulations in India

under PREA requirements, it is essential to obtain an
FDA-approved WR before submitting pediatric studies.
The FDA will not grant exclusivity until after receiving
an approved WR submission, which can occur without
requiring sponsor proposals.
Research projects covered by the BPCA or PREA need
to have a pediatric-specific security review done by the
Pediatric Advisory Committee within 18 months of the
FDA approving a label update. Table 3 represents the
41
conventional “standards” for pediatric medication registry. 70
Figure 4. Progress of pediatric drug regulations 64 6. Regulatory mandates and conditions
Abbreviations: AAP: American Academy of Pediatrics; BPCA: Best
Pharmaceuticals for Children Acts; FDA: Food and Drug Administration; 6.1. Plan for pediatric development
FDAMA: Food and Drug Administration Modernization Act; FDASIA:
Food and Drug Administration Safety and Innovation Act; FD&C: 6.1.1. EU
The Federal Food, Drug, and Cosmetics Act; PAC: Premature Atrial The requirement to consent to a pediatric investigational
Contraction; PREA: Pediatric Research Equity Act.
plan or waiver is relevant in the following situations:
(i) For all new products, regardless of whether they
5.4. PREA are safeguarded through patent or supplemental
The PREA mandates that sponsors assess the safeguards protective certificates
and effectiveness of novel items, including pharmaceuticals (ii) When a petition is filed for a new diagnosis, dosages,
and biological agents, in youngsters under particular or mode of administration for approved drugs
circumstances. However, a waiver from the FDA can be protected by a relevant patent or SPC (designed for
granted. The PREA applies to any product registration usage by adult or juvenile classification).
for a novel dosage type, novel effective component, novel These regulations also cover items that have been
dosing schedule, novel mode of administration, or novel granted orphan status inside the EU. The exceptions include
indications. These studies are compulsory but are confined biological products that are hybrid, biosimilar, or generic;
to the approved indications in adults. The submission of they also include homeopathic and ayurvedic remedies, as
an initial Pediatric Study Plan (iPSP) is mandatory for all well as those that are approved under the ethical principle
product development programs subject to PREA. Product of “well-established use.” 42
development programs for biosimilars, unless exempted by
orphan classification, must comply with PREA regulations. 40 It is important to remember that fulfilling a responsibility
in the EU entails incentives. The particular benefits are
At the start of the medication development process, the attainable in the context of accepting a PIP (and carrying out
PSP aims to determine critical juvenile research needs and research). Stated differently, as the EU has a unified legislative
start preparations for these studies. Any marketing proposal framework for both incentives and requirements, adhering
covered by PREA should incorporate an agreed-upon to it qualifies one for a biannual patent extension or a 2 years
preliminary PSP. It is critical to discuss with the FDA if a extension of exclusivity on the market (for items designated
pediatric developmental project is deemed inappropriate. as orphans). In addition, a brand-new category of marketing
The FDA urges sponsors to include all possible permission called pediatric use marketing authorization
juvenile advancement plans in the PSP, even those that (PUMA) was created to promote the advancement of
fall within BPCA, even though a PSP is only necessary approved products for pediatric markets that are currently
for pharmaceutical advancement projects under PREA. not covered by intellectual property rights.
Proposed pediatric study requests (PPSR) may use these Ten years of data exclusivity are awarded to a PUMA
strategies as the foundation to get a WR. As a result, a single for goods created specifically for usage within the juvenile
product might include a WR and a PSP also, enabling both patient following a PIP. 43
required and optional studies as well as the possibility of
BPCA incentives if the product complies with the trials 6.2. Exemptions/waivers
in the WR. It is noteworthy that although exclusivity is 6.2.1. EU
granted under the BPCA utilizing an approved WR, as
opposed to a PREA, the PSP is ineligible to function as The EMA has the power to give an exemption (waiver) that
a PPSR. Furthermore, when seeking pediatric exclusivity applies to some pediatric subsets, such as age groups, or to

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