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INNOSC Theranostics and
Pharmacological Sciences Pediatric drug regulations in India

(i) In the US, pediatric exclusivity is obtained through exclusivity period, which is awarded if a pediatric
a different legislative framework than the obligation, indication is provided
as PREA and BPCA are two distinct laws with (viii) About orphan products: Orphan products are
separate legal foundations and procedures. This likewise subject to pediatric exclusion in the US,
distinction may lead to different requirements for unlike in Europe, where there are distinct rewards
pediatric research. However, in the EU, since the (as previously indicated). In addition, it prolongs
specifications and rewards are covered by the same the current patent and marketing durations as
laws and regulations, no further research is required well as orphan exclusivity and Hatch Waxman
to ensure exclusivity Act protection, which are designed to shield novel
(ii) The EU and the US have different legislative pharmaceutical goods from competition from
frameworks. While “condition” is broadly construed generic versions (Figures 5 and 6).
in EU legislation according to their policy on In contrast, sponsors of research involved in a PIP
determining condition(s) for a pediatric research plan/ agreement in the EU are granted a 10-year data protection
waiver (pediatric research plan/waiver scope), the US period under the PUMA. 47
statute limits the requirement to adult indications. The
BPCA exclusivity procedure must be used for some 7. Guidelines and procedural advice for PIP,
pediatric disorders that do not arise in adults PSP, and WR submission, evaluation, and
(iii) The primary benefit is associated with the SPC/ modification procedures and timelines
patent in the EU, while it pertains to security for
patents and exclusivity as outlined in the US Orange 7.1. EU
Book for every medication item that includes the The European Commission Guidelines on the layout and
investigated active component substance of PIP and waiver submissions are the primary
(iv) In the EU, products approved centrally can be regulation accessible in the EU for producers of medical
promoted across every country of markets, but goods concerning pediatric legislation. It was most recently
SPC/patents are granted by every member country, amended in 2014. Additional procedural guidance can be
potentially resulting in variations or absence of SPCs found on the EMA website.
across different member countries. Meanwhile, in
the US, a medication authorized by the FDA can be To streamline overall development and integrate the
marketed nationwide pediatrics program into the adult program, early discussion
(v) The incentive in the US applies solely to the optional of it is essential. Obtaining a PIP before requesting clinical
BPCA-written application regulatory procedure. trial permission for pediatric research is strongly advised.
When research is required due to PREA obligations Within the EU, clinical trials are not EMA, but the appropriate
(e.g., under a PSP), there is no cash reward. However, participating country’s jurisdiction or states where the trial
if a medication falls under both a PSP and WR and would take place are in charge of granting authorization.
consequently has both required and discretionary A member state does not need to validate an earlier PIP
studies included, there is potential eligibility for agreement to obtain authorization. Nevertheless, requesting
incentives if required conditions are met a retrospective PIP after receiving authorization could not
(vi) Incentives in the US are limited to the optional ensure the Pediatric Committee (PDCO)’s consent and might
BPCA-written application regulatory procedure. result in further requirements that waste time and resources. 48
There is no financial incentive when research is PIP applications are submitted by sponsors to the EMA
required as part of PREA responsibilities (such as for assessment by the PDCO. The commission is in charge
under a PSP). However, if a product is covered by of evaluating PIPs from a scientific standpoint and reaching
both a PSP and WR As a result, both necessary and a consensus. Under these plans, sponsors may be permitted
elective studies are incorporated; if prerequisites are to implement all or certain PIP measures following their
satisfied, there may be an opportunity for incentives application for marketing permission for adults, with the
(vii) For any medications containing the active moiety, option for deferrals. The EMA will decide on the approved
a further 6 months of pediatric exclusion is PIP (or complete waiver) within 10 days of obtaining the
permissible in the US but impermissible in the PDCO’s final opinion. Excluding any clock-stop periods —
EU. It is noteworthy that in the US, pediatric that is, the time applicants take to reply to PCDO requests
exclusivity is only applicable for the first 6 months – the EMA has a maximum of 7 months to decide on a PIP.
for all medicines containing the active moiety. Only In actuality, the full process often takes a year because the
the product under study is eligible for the second average interval is roughly 135 days long. 49

Volume 7 Issue 4 (2024) 10 doi: 10.36922/itps.3831