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INNOSC Theranostics and
Pharmacological Sciences Pediatric drug regulations in India

not). Figure 7 represents the schedule of modifications to “clinical assessment reporting system” have been put into
55
regulations for the advancement of pediatric medications. place. 58

9. Pediatric drug regulations in Japan The FDA recently published three guidelines to
encourage the initial advancement of medical devices for
Since there are no legal requirements for the production pediatrics. These include the 2014 Guidance on Pre-
58
of pediatric medication in Japan, the Ministry of Health, market Assessment of Pediatric Medical Devices, the
Labor and Welfare (MHLW) has implemented a range of 2014 Guidance on Providing Information about Pediatric
initiatives since 2000 to encourage its advancement. 56 Uses of Medical Devices, and the 2016 Guidelines for

On December 22, 2014, the “Ethical Guidelines for Using Clinical Data Already Available to Extrapolate
Medical and Health Research Involving Human Subjects” to Pediatric Medical Device Usage. Together with these
(issued by the Ministry of Education, Culture, Sports, initiatives centered on pediatrics, other programs, such
Science and Technology and MHLW) were established as the Breakthrough Device Program, have been initiated
by merging two existing government guidelines: “Ethical by the FDA to encourage innovation in medical devices.
Guidelines for Epidemiologic Research” and “Ethical Furthermore, regulatory authorities such as PMDA in
Guidelines for Clinical Research.” These new ethical Japan have also supported using registry data to enhance
guidelines marked the first instance of incorporating evaluation processes for pediatric medical devices while
regulations on “obtaining assent,” a procedure particularly reducing costs and enhancing efficiency. 59
relevant to children. This development indicates that Japan In addition, three distinctive Japanese projects that are
is taking initial steps toward addressing issues related to expected to greatly improve the development of pediatric
children. medical devices were found through a search on the
New and distinct pathways for regulation, such as PMDA webpage in December 2019: “Conditional Early
the “high-need medical devices,” “system for designating Approval System for Innovative Medical Device Products,”
orphan medical devices,” the “Sakigake strategy,” “fast- “PMDA Science Board on Evaluation of Medical Devices
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break scheme for innovative medical devices,” and in Pediatric Use,” and “Subsidization Program for
“clinical evaluation report system” were introduced to Application of Pediatric Medical Device.” Each initiative’s
assist the advancement of orphan medical devices in goals and achievements were examined using data that
Japan. A significant obstacle in obtaining approval for were made public by the MHLW and the PMDA. The
medical devices targeting rare diseases is meeting clinical Japan Federation for Development of Medical Devices
evaluation requirements. As alternatives to the traditional website was another source of information regarding the
submission procedure needing clinical study data, novel Orphan Medical Equipment Registration System that was
approval routes such as the “fast-break scheme” and the examined. 60

Table 4. Regulatory documents issued in China 71

Guidelines Regulations Important considerations
“Guideline 2014” “Guideline on Pharmacokinetic Studies in Pediatric (i) Pharmacokinetics in the pediatric population: Study design,
Population” methodology, and regulatory considering
“Guideline 2016” “Guideline on Clinical Trials in the Pediatric Population” (i) Monitoring and ensuring the safety of data categorizing patients by age
(ii) Commencement duration for drug administration
(iii) Testing drugs in clinical trials involving children
(iv) Planning clinical trials for pediatric patients
(v) Choosing suitable dosage forms for children
(vi) Conducting clinical trials for rare diseases in the pediatric population
(vii) Ethical factors to consider
“Guideline 2017” “Guideline on Extrapolation from Adults to Pediatric (i) Idea of extending beyond known data
Patients” (ii) Process of predicting based on existing information
(iii) Modeling and simulation
(iv) Fundamental principles and necessary conditions
“Guideline 2020” “Guideline on the Use of Real-World Research to Support (i) Distinctions and suitable integration of experimental in relation to
Development and Regulatory Evaluation for Pediatric conventional randomized controlled clinical studies
Drugs” (ii) Typical circumstances for the application of practical studies in
China’s medicine discovery for children

Volume 7 Issue 4 (2024) 14 doi: 10.36922/itps.3831