Paediatric Committee

The establishment of the Paediatric Committee within the EMEA. The Paediatric Committee will have expertise in all aspects of research, development, authorisation and use of medicines in children. 

The BNF Joint Formulary Committee as of May 2005 will publish a Paediatric version annually. It will comprise monographs on safe and effective medicines for use in children, even if usage in children is not included in the summary of product characteristics (SPC). 

There is widespread and easy availability of high-dose single and multiple vitamin formulations, often presented as food supplements. This creates a potential for chronic or sporadic intake of high doses of vitamins and the occurrence of unanticipated adverse effects (11,12). The cases often involve children, who may be specially vulnerable to the effects of overdosage. The Canadian Paediatric Society s Nutrition Committee in 1990 issued a warning to physicians, based on an estimate that as many as 10% of healthy Canadian children were being exposed to vitamin polypharmacy and a substantial risk of accidental overdose (13). 

Nutrition Committee, Canadian Paediatric Society. Megavitamin and megamineral therapy in childhood. CMAJ 1990 143(10) 1009-13. 

ESPGAN. 1991. European Society of Paediatric Gastroenterol and Nutrition Committee on Nutrition Comment on the Content and Composition of Lipids in Infant Formulas. Acta Paediatrica Scand. 80 887-896. 

Rieder MJ, Canadian Paediatric Society, Drug Therapy and Hazardous Substances Committee (2011) Drug research and treatment for children in Canada a challenge. Paediatr Child Health 16 560-561... 

International Conference on Harmonisation of Technical Requirements of Pharmaceuticals for Human Use (ICH). Topic Ell Note for Guidance on Clinical Investigation of Medicinal Products in the Paediatric Population. CPMP/ICH/2711/99. London European Agency for the Evaluation of Medicinal Products, 1999 (Draft). Committee for Proprietary Medicinal Products. Note for Guidance on Clinical Investigation of Medicinal Products in Children CPMP/EWP/462/95. London European Agency for the Evaluation of Medicinal Products, 1997. 

EMEA (European Medicines Agency, Committee for Human Medicinal Products). Guideline on the need for non-clinical testing in juvenile animals on human pharmaceuticals for paediatric indications (Draft). 2005. EMEA/CHMP/SWP/169215/ 2005. 

The Ethics Committee, with paediatric expertise or after taking advice in clinical. Article 4.h ... 

Royal College of Paediatrics and Child Health Ethics Advisory Committee (2000). Guidelines for the ethical conduct of medical research involving children. Arch Dis Child 82 177-182. 

WHO Expert Committee on Specifications for Pharmaceutical Preparations (2012) Atmex 5 development of paediatric medicines points to consider in formulation. WHO technical report series no. 970. http //apps.who.int/medicinedocs/dociunents/sl9833en/ sl9833en.pdf... 

BOX 1-1 Key Points of the European Society for Paediatric Gastroenteroiogy, Hepatology, and Nutrition s Committee on Nutrition Commentary on the Nutritional and Safety Assessment of Breast Milk Substitutes and Other Dairy Products for Infants... 

McIntosh, N., Bates, R, Brykczynska, G., Dunstan, G., Goldman, A., Harvey, D., Larcher, V., McCrae, D., McKinnon, A., Patton, M., Saunders, J. and Shelley, R, Guidelines for the ethical conduct of medical research involving children. Royal College of Paediatrics and Child Health Ethics Advisory Committee. Arclt. Dis. Child., 82, 177-182 (2000). 

Committee on Infectious Diseases (1993) Vitamin A treatment of measles. Pediatrics 91 1014-1015 Australian College of Paediatrics (1996) Policy statement. Vitamin A supplementation in measles. J Paediat Child Health 32 209-210... 

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