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Common Commentary on Paediatric Oncology Drug Development Published: Another Step in Optimising Global Regulatory Coordination of Paediatric Development Plans

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Abstract

The European Medicines Agency and the US Food and Drug Administration recently published a common commentary document on paediatric oncology drug development, building on the call for simultaneous submissions of paediatric investigation plans and initial pediatric study plans. The objective of this document is to guide deliberations and permit focused discussions at the monthly paediatric cluster calls, allowing early regulatory coordination of global development plans. The differences in regulations related to timeline are not considered posing a barrier in that regard.

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References

  1. European Medicines Agency. https://www.ema.europa.eu/en/documents/other/common-commentary-ema/fda-common-issues-requested-discussion-respective-agency-ema/pdco-fda-concerning-paediatric-oncology-development-plans-paediatric-investigation-plans-pips_en.pdf. Accessed 30 June 2021.

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Authors and Affiliations

  1. Paediatric Medicines Office, Human Medicines Division, Scientific Evidence Generation Department, European Medicines Agency (EMA), Amsterdam, The Netherlands

    Dominik Karres, Franca Ligas, Giovanni Lesa & Ralph Bax

  2. Oncology Center of Excellence, Office of the Commissioner, Office of Oncologic Diseases, Office of New Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration (FDA), Silver Spring, USA

    Gregory Reaman

  3. Office of Pediatric Therapeutics, Office of the Commissioner, US Food and Drug Administration (FDA), Silver Spring, USA

    Susan McCune, Suzanne Malli & Jean Temeck

Authors
  1. Dominik Karres
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  2. Gregory Reaman
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  3. Franca Ligas
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  4. Giovanni Lesa
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  5. Susan McCune
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  6. Suzanne Malli
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  7. Ralph Bax
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  8. Jean Temeck
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Corresponding author

Correspondence to Dominik Karres.

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Disclaimer The views expressed in this article are the personal views of the authors and may not be understood or quoted as being made on behalf of, or reflecting the position of, the agencies or organizations with which the authors are affiliated.

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Karres, D., Reaman, G., Ligas, F. et al. Common Commentary on Paediatric Oncology Drug Development Published: Another Step in Optimising Global Regulatory Coordination of Paediatric Development Plans. Ther Innov Regul Sci 55, 1109–1110 (2021). https://doi.org/10.1007/s43441-021-00339-z

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  • DOI: https://doi.org/10.1007/s43441-021-00339-z

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