Discussion on the Technical Development of Pediatric Pharmacovigilance

Abstract

Abstract: This article is based on the theory and the practice of pharmacovigilance(PV), and combined with the essential character of pediatric medication. The writer discusses on the special characteristics of pediatric PV, the role and responsibilities of different stakeholders, PV before authorization of a pediatric indication and PV for products on the market. We try to establish the frame of pediatric PV, and hope this pilot helpful for the practice of PV on special population like children.

Key words: medicines used by the pediatric population, pharmacovigilance, development

CLC Number:

R954

SHEN Lu, DU Xiao-xi. Discussion on the Technical Development of Pediatric Pharmacovigilance[J]. Chinese Journal of Pharmacovigilance, 2011, 8(4): 220-224.

References

[1] ICH.ICH E11 Note for Guidance on the Clinical Investigation of Medicinal Products in the Paediatric Population(CPMP/ICH/2711/99)[EB/OL].2000-01[2010-12-25].http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500002926.pdf.
[2] EMEA CHMP Guideline on Risk Assessment of Medicinal Products on Human Reproduction andLactation: from Data to Labelling(EMEA/CHMP/203927/2005)[EB/OL].2006-03[2010-12-25].http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_gui-deline/2009/09/WC500002926.pdf.
[3] EMEA. CHMP guideline on conduct of pharmacovigilance for medicines used by the pediatric population （EMEA/CHMP/PhVWP/235910/2005- rev.1[EB/OL].2006-03[2011-01-01].http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003764.pdf.
[4] ICH. ICH S5(R2) Note for Guidance on the Detection of Toxicity to Reproduction for Medicinal Products&Toxicity to Male Fertility(CPMP/ICH/386/95)[EB/OL]. 2008-02[2011-01-01].http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003103.pdf.
[5] EMEA CHMP Guideline on the need for Non-Clinical Testing in Juvenile Animals on Human Pharmaceuticals for Paediatric Indicat-ions(EMEA/CHMP/SWP/169215/2005)[EB/OL]. 2008-01[2011-01-01].http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003305.pdf.
[6] Evans W E,Hom Y Y,Bomgaars L,et al. Preponderance of thiopurine-methyltransferase deficiency and heterozygosity among patients intolerant to mercaptopurine or azathiopurine[J].J clinoncol.2001,19(8):2293-2301.
[7] EMEA CHMP Guideline on Risk Management System for Medicinal Products for Human Use(EMEA/CHMP/96268/2005) [EB/OL]. 2005 -11-14[2011-01-01].http://www.ema.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_guideline/2009/10/WC500004888.pdf.
[8] ICH. ICH E2C(R1) Note for Guidance on Clinical Safety Data Management: Periodic Safety Update Reports for Marketed Drugs (CPMP/ICH/288/95) and Addendum [EB/OL]. 1995-12[2011-01-01].http://www.ema.europa.eu/docs/en_GB/document_library/Press_release/2009/12/WC500017234.pdf.
[9] EMEA EWP Guideline on Clinical Trials in Small Populations (CHMP/EWP/83561/2005)[EB/OL].2005-01-27[2011-01-01].http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003766.pdf.
[10] Evans S J, Waller P C, Davis S. Pharmacoepidemiol[J].Drug Saf, 2001,10(6):483-486.

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