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Rationalising Optimal Dosing of Phytotherapeutics For Use In Children: Current Status - Potential Solutions - Actions

Andreas Hensel1, Rudolf Bauer2, Michael Heinrich3

  • 1Institute of Pharmaceutical Biology and Phytochemistry, University of Münster, Germany.

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|March 25, 2024
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Summary
This summary is machine-generated.

Herbal medicinal products (HMPs) for children show promise but face regulatory hurdles. Adapting the regulatory framework and rationalizing dosing are crucial for safe and effective paediatric use of HMPs.

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Area of Science:

  • Pharmacology
  • Paediatric Medicine
  • Regulatory Science

Background:

  • WHO emphasizes children are not small adults, prompting EU paediatric regulations in 2007.
  • Despite regulations, progress in paediatric herbal medicinal products (HMPs) remains limited.
  • A symposium assessed the status and challenges of HMPs for children.

Purpose of the Study:

  • Evaluate the current situation of paediatric HMP use.
  • Identify reasons for the lack of progress.
  • Discuss strategies for proving HMP safety and efficacy in children.

Main Methods:

  • Review of current legislative requirements and European national regulations.
  • Analysis of existing data and consideration of new approaches like real-world data (RWD).
  • Discussion on adapting regulatory frameworks and rationalizing dosing strategies.

Main Results:

  • Paediatric HMPs are effective and safe, but current use doesn't meet legislative standards.
  • Varied national regulations and traditions complicate HMP registration and marketing in Europe.
  • EU herbal monographs offer a common standard, but safety discussions and RWD are emerging considerations.

Conclusions:

  • There's a significant need to revise restrictions on paediatric HMP use.
  • Rationalizing dosing regimes for children is essential.
  • Adapting the regulatory framework and utilizing RWD can improve paediatric HMP development.