Page 36 - ITPS-7-4

INNOSC Theranostics and
Pharmacological Sciences Pediatric drug regulations in India

on the BPCA-WR procedure, and there is also availability
for a 1999 advisory document that is currently undergoing
revision.

Based on an individual initiative or a request from a
stakeholder, the FDA can issue a WR. To accelerate the
FDA’s issuing of a WR, sponsors are strongly advised to
submit a PPSR to ensure pediatric exclusivity. Sponsors
are advised to refer to the “Guidelines for Industries
Qualifying for Pediatric Exclusion within Section 505A of
the Federal Food, Drug, and Cosmetic Act” for guidance
on what should be included in the PPSR. We are at the
moment revising this policy document. Sponsors must
make sure that their PPSR is submitted with adequate
time (about 120 days) for both FDA review and Pediatric
Review Committee discussion. 50

7.2.3. Variations in documentation submission
When comparing PIP and PSP, the section titles in the PSP
template closely resemble those of the EU PIP model for
intellectual documents (parts B to E), even appearing in
the same order.
The FDA generally requires less detailed background
information on aspects such as a product’s characteristics
and its development in adults, as their technical review
divisions handle all studies and data related to both mature
and juvenile patient development from the opening of an
investigational NDA by the sponsor. Conversely, when
sponsors reach out to EMA with a PIP application in the
EU, they may need to provide more detailed information
since it is often their first interaction with them.
Despite this difference, both regions expect concise,
Figure 5. Guidelines for the development and study of pediatric medications 63 stand-alone applications: In the EU, it is suggested that each
Abbreviations: EMA: European Medical Agency; FDA: Food and Drug scientific document for a PIP application should not exceed
Administration.
40 pages per condition, whereas PSP applications submitted
7.2. US within the US should include between 12 and 60 pages. 51
This information on the advancement of medications 7.3. The initial submission of relationships with
for pediatrics can be found on the FDA website under regulations
“Pediatric Product Development.”
7.3.1. EU
7.2.1. Pediatric study plans EMA has been providing free early pediatric interaction

Furthermore, by consulting the preliminary guideline sessions with sponsors since June 2015 to encourage timely
paper entitled “Content of and Procedure for Submitting conversations about pediatric advancement and the timing
iPSP and Amended iPSP,” sponsors can receive assistance in and substance of PIP submission. Before submitting a PIP,
accomplishing the initial PSP applications. A preliminary this new initiative seeks to enable discussion regarding
PSP template that is similar to the PIP application template addressing pediatric necessities relating to a particular
is also included in this document. product. In addition, to guarantee a quick validation
procedure at the time of application, a professional initial
7.2.2. WR submission discussion can be set up several months before
A frequently asked question (FAQ) concerning the applying for a PIP or waiver. The PIP/waiver application
pediatric exclusivity process is accessible to offer details questions and answers offer guidance.

Volume 7 Issue 4 (2024) 11 doi: 10.36922/itps.3831