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Guidance on the submission, processing and assessment of all completed paediatric studies sponsored by marketing authorisation holders (MAHs).
An overview of the legal requirements for children’s medicines that Marketing Authorisation Holders (MAHs) need to abide by.
Update of indicators for hospital admissions for children with asthma, diabetes, epilepsy, gastroenteritis and respiratory tract infections, overall emergency admissions and A&E attendance for different age groups.
The process for applicants applying for a paediatric investigation plan (PIP) modification or waiver.
These reports explain our assessment of the scientific evidence used to lead to regulatory decisions on the safety of medicines or medicines classes.
By Julia Vitarello
How to apply for a clinical trial including eligibility, phases, model IMPDs, costs and how to make changes to your application.
Safety leaflet on topical corticosteroids and withdrawal reactions to help patients and their carers to use these medicines safely.
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