Module 1 2021

01/07/2021

No only in the EU is paediatric development required

• FDA- PREA; Paediatric Research Equity Act • PREA gives FDA the authority to require paediatric studies in certain drugs and biological products. Studies must use appropriate formulations for each age group. • The goal of the studies is to obtain paediatric labeling for the product. • Procedure of PREA is different than PIP procedure; • before approval PIP needs to include all measures and details • PREA can be filled during development and after gaining additional knowledge • When studies are needed for the USA and for EU, effort is made for shared requirements; • Regular TC meeting FDA-EMA to PIP’s and PREA’s • Joint workshops with FDA and EMA (and HC, PMDA, TGA…)

The Organisation for Professionals in Regulatory Affairs

29

Challenges and possibilities

The Organisation for Professionals in Regulatory Affairs

30

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