WHO Technical Report Series, No. 957 - Multiple Choices - World ...

Finally, a review of the roles and responsibilities of the Expert Committeeon Biological Standardization was proposed. It was approximately 10 yearssince the last such review and thus it was important to have such anexternal validation of the direction and output of the Committee. As partof the process comments from the Expert Committee on Specifications forPharmaceutical Preparations would be invited.2.2.3 Blood productsThe Committee was informed about WHO’s work in the area of bloodproducts and related biologicals. More details on the GMP for bloodestablishments can be found in section 6.6.2.2.4 Essential medicinesFurther to the WHO-led initiative “make medicines child size” launchedin December 2007, WHO received a grant from the Bill & Melinda GatesFoundation in October 2008 to work in collaboration with UNICEF in orderto conduct crucial research in the area of children’s medicines. The aim ofthe project was to increase the number of child-size medicines designedand formulated specifically for children. The grant provided support foressential research to:— determine the optimum dosage forms for paediatric medicines (e.g.small tablets, dispersible tablets, powders);— develop dosing guides (e.g. a review of existing priority medicinesand the identification of the appropriate doses for new medicines forchildren); and— develop guidelines for testing of medicines and treatment of use ofmedicines in children, including guidelines on conducting clinical trialsin children.In December 2008 a group of paediatricians, pharmacists, clinicalpharmacologists and representatives of the European Medicines Agency(EMA), International Federation of Pharmaceutical Manufacturers andAssociations (IFPMA), Medicines for Malaria Venture (MMV), NationalInstitutes of Health (NIH), United Nations Children’s Fund (UNICEF) andthe Bill & Melinda Gates Foundation attended a meeting hosted by WHO todiscuss the preferred dosage form of medicines for children. As a result ofthis consultation the dosage forms of medicines most suitable for childrenwere identified, with particular attention paid to conditions prevailing indeveloping countries and future areas of research required in this area (http://www.who.int/childmedicines/progress/Dosage_form_reportDEC2008.pdf).The report of the WHO Subcommittee for the Selection and Use ofMedicines, including the second Essential Medicines List for Children(EMLc), was reviewed and endorsed by the Expert Committee on Selection11