Page 34 - ITPS-7-4

INNOSC Theranostics and
Pharmacological Sciences Pediatric drug regulations in India

Table 3. Conventional “standards” for pediatric medication registry 70
Important subject Potential response
Standardization of terminologies • Encourage cooperation across authorities to promote discourse on the Pediatric Development Plan (PDP)
PDP • Provide recommendations for safety, effectiveness, and efficiency
• Provide general guidance on dose formats
• Give technical guidance on age ranges, particular illnesses, pediatric medication dosages, and parts of research
in underdeveloped nations
• Provide guidelines for the PDP’s assessment and material
• Offer education and development of capacity
Proposal for permission to perform • Gather frequently asked questions on conducting clinical studies, with a focus on developing nations; respond
clinical research to them and offer references to previously published material (such as that from the FDA or EMA)
• Create a reference document
• Create a useful guide with FAQs and answers
Pharmacovigilance • Recognition of interested parties and available resources (networks, databases, etc.)
• Creation of suitable documentation
Authentication for The • Provide guidelines for the assessment of the application dossier’s contents
commercialization • Specify the supporting documentation that should be sent with the marketing authorization application in cases
where a different NMRA has previously evaluated the pediatric plan or dataset
• Create retraining and capacity‑building initiatives for NMRAs
Transparency of the Network’s • Utilize the World Health Organization (WHO)’s website to share knowledge, such as national regulatory
activities documents.
• Send out the Network Newsletter biannually
• Hold network meetings yearly
Advocacy for research on and • Track global network activity (e.g., WHO to secure a time slot for the 2010 ICDRA summit)
development • Reporting network operations (e.g., Ministries of Health)
• Determining the National Center of Excellence for pediatric issues
Abbreviations: EMA: European Medicine Agency; FAQ: Frequently Asked Questions; FDA: Food and Drug Administration; ICDRA: International
Conference of Drug Regulatory Authorities; NMRA: National Medical Regulatory Authority; WHO: World Health Organization.

6.4. Incentives and rewards when the calculated length of the SPC is either negative or
zero.
Financial incentives are linked to the right to intellectual
property in both the US and the EU. This is implemented As opposed to the typical 10-year period provided as
in the EU as a 6-month SPC prolongation, which prolongs part of the orphan reward, designated orphan products in
the patent. In the meantime, the complete product line with the EU receive a separate payment (whether or not they are
an active moiety will have its market protection extended covered by a patent), which includes two additional years
for an additional 6 months in the US. of market exclusivity, regardless of patent status.

Regardless of whether new pediatric indications are Finally, off-patent items that receive a PUMA in the
granted or studies fail to demonstrate efficacy (“negative” EU following the completion of a PIP qualify for an
studies), companies can obtain these financial incentives additional benefit: extended data protection lasting for
in both regions. What matters is that results from these several years.
studies are incorporated into product information
(labeling). Instead of focusing only on successful studies, 6.4.2. US
the emphasis is on rewarding pediatric development The initial term of exclusivity is covered by market security
activities. Both areas value “negative” information, which and can be extended for 6 months for the products
tells us when it is inappropriate to provide medication to a containing the active component. A second exclusivity
child and requires it to be listed on product labels. 46 period would apply only to the particular product under
investigation. In the US, an internal FDA review process
6.4.1. EU is followed. If the submission was issued before September
An SPC is required to be eligible for the primary EU 27, 2007, and contains research defined in the WR, it will
benefit; the patent alone is insufficient. As to the ruling of be evaluated within 90 days. For applications submitted
the European Court of Justice, sponsors can still pursue beyond this date, a decision must be made within 180 days
an SPC to receive the pediatric benefit, even in situations of receipt.

Volume 7 Issue 4 (2024) 9 doi: 10.36922/itps.3831