Module232025

12/05/2025

Paediatric Medicines Expert Advisory Group (EAG)

• Remit: advise the CHM (Commission for Human Medicines) on the safety, quality and efficacy of medicines for paediatric use, including all matters relating to the implementation of the Paediatric Regulation • Impartial advice from a wide range of highly-skilled professionals and academics who are senior and well regarded in their respective fields and from a range of appointed lay representatives

• External experts on ad-hoc basis

Patient engagement

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• Current work in progress to extend academic interactions

The Organisation for Professionals in Regulatory Affairs

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Regulatory Framework -Switzerland

TPA (Federal Act of 15 December 2000 on Medicinal Products and Medical Devices (SR 812.21)

• Art. 11 para. 2 a, no. 6 Authorisation application

• Art. 54a Paediatric investigation plan TPO (Ordinance of 21 September 2018 on Therapeutic Products (SR 812.212.21)

Art. 5 Paediatric investigation plan

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Art. 9 para. 5 Authorisation

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• Art. 84 Paediatric investigation plan TPLRO (Ordinance of the Swiss Agency for Therapeutic Products of 9 November 2001 on the Licensing Requirements for Therapeutic Products (SR 812.212.22)

• Art. 13 para. 2 Information for healthcare professionals

The Organisation for Professionals in Regulatory Affairs

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