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CTD Module 1
1.10 Information relating to paediatrics
This section of Module 1 holds information relating to the applicant’s paediatric development program.
Summary of requirements
|Section||Description||Category 1/COR report-based||Variations to quality only (e.g. Category 3)|
|New registration||Variation||New registration||Variation|
|1.10.1||Information relating to paediatrics||requirement defined by the regulatory activity||not required||not required||not required|
When to include information relating to paediatrics
Include in all regulatory activities to register:
- a new chemical entity
- new combination
- extension of indication
- major variation.
How to prepare information relating to paediatrics
Complete the Paediatric development program form and include it in Module 1.10 of the dossier.
The form includes advice as to whether there is a paediatric development program for this medicine and provides TGA with information, relevant to the Australian application, about the data submitted, paediatric clinical study commitments given and waivers received in the European Union and United States of America.
A paediatric investigation plan (PIP) is a development plan aimed at ensuring that the necessary data are obtained through studies in children, when it is safe to do so, to support the authorisation of a medicine for children. All applications for marketing authorisation for new medicines that were not authorised in the EU before 26 January 2007 have to include the results of studies carried out in children of different ages as described in the PIP. This requirement also applies when a company wants to add a new indication, pharmaceutical form or route of administration for a medicine that is already authorised and patented.
United States of America
The Pediatric Research Equity Act (PREA) authorises the Food and Drug Administration (FDA) to require paediatric studies of drugs or biologics. Under PREA, a paediatric assessment is required for new applications, except when waived or deferred, and is designed to provide data needed to evaluate the safety and efficacy of a drug or biologic and to support dosing and administration for each paediatric subpopulation for which the product has been found safe and effective.
The Best Pharmaceuticals for Children Act (BPCA), enacted in 2002, encourages the manufacturers, or applicants, of drugs that still have marketing exclusivity, that is, are on-patent, to conduct paediatric drug studies, as requested by the FDA. If they do so, FDA may extend for 6 months the period during which no equivalent generic drugs can be marketed.
The TGA has adopted internationally recognised ICH/European guidelines concerning paediatric data generation and facilitating the extrapolation of data from one patient population to another, including:
- Note for guidance on clinical investigation of medicinal products in the paediatric population (CPMP/ICH/2711/99)
- Guideline on the role of pharmacokinetics in the development of medicinal products in the paediatric population (EMEA/CHMP/EWP/147013/2004Corr)
- Guideline on the investigation of medicinal products in the term and preterm neonate (EMEA/536810/2008)
- Guideline on conduct of pharmacovigilance for medicines used by the pediatric population (EMEA/CHMP/PhVWP/235910/2005/rev.1)
- Reflection paper: Formulations of choice for the paediatric population (EMEA/CHMP/PEG/194810/2005)
- Paediatric addendum to CHMP guideline on clinical investigation of medicinal products in the treatment of lipid disorders (EMA/CHMP/494506/2012)
- Paediatric addendum to CHMP guideline on the clinical investigations of medicinal products for the treatment of pulmonary arterial hypertension (EMA/CHMP/213972/2010).