EU Regulation (EC) No 1901/2006 - Medicinal Products for Paediatric Use

What it says

The Paediatric Regulation aims to improve the development and availability of medicines for children. It requires applicants for marketing authorization of new medicines to include the results of studies in line with an agreed paediatric investigation plan, unless a waiver or deferral applies. Plans are agreed with the Paediatric Committee, and the Regulation provides rewards such as extension of supplementary protection.

Paraphrased for plain-language clarity. Always verify against the current published regulation text.

What it means in practice

• A paediatric plan must be agreed early, usually by the end of the early human studies.
• Compliance with the agreed plan is checked before an application is validated.
• Waivers and deferrals are possible but have to be justified.

What inspectors look for

• Whether an agreed plan exists and was followed.
• Whether studies in children were conducted to the plan.
• Whether changes to the plan were agreed.

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