Module232025

12/05/2025

Agenda

Regulatory frameworks • USA • UK • Switzerland • Japan • Canada • WHO

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• International Collaboration Efforts

The Organisation for Professionals in Regulatory Affairs

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USA Legislation and regulations with important paediatric drug regulation Impact Legislation Year

• Requires manufacturers to survey existing pediatric data and to labelling • Pediatric‘Extrapolation’ introduced

1994

Pediatric Labeling Rule

• FDA could ask for pediatric trials. • 1 st incentive program: 6 months marketing exclusivity granted to the sponsors, if studies are done in pediatrics • Section 505A of Federal Food, Drug and Cosmetic Act • Financial incentive to voluntarily conduct pediatric trials • FDA and NIH to obtain information to support labelling in pediatric patients • Section 505B of Federal Food, Drug and Cosmetic Act • Requires companies to assess safety and effectiveness of certain products in pediatric patients • 1 st requirement for conduct of pediatric trials in certain drugs

1997

FDA Modernization Act

1998 2002

Pediatric Rule

Best Pharmaceuticals for Children Act (BPCA)

2003

PediatricResearch Equity Act (PREA)

• Reauthorized BPCA and PREA

2007

FDA Amendments Act

The Organisation for Professionals in Regulatory Affairs

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