A special Paediatric Task Force has been created to improve availability of medicines and vaccines for children.
The International Federation of Pharmaceutical Manufacturers and Associations has developed the task force to identify and address opportunities to expand medicine development for children. The task force will work with intergovernmental and non-governmental organisations, including the World Health Organisation, which launched its own ‘Make medicines child size’ campaign last year.
“The IFPMA Paediatric Task Force will enable more focused work between the industry and other stakeholders, to address effectively and concretely the various obstacles to developing more medicines adapted for children, especially for the developing world,” said Alicia Greenidge, Director General of the IFPMA.
Concerns that will be addressed through the task force include: appropriate dosage forms and strengths of medicines for children; encouraging R&D of appropriate medicines for diseases that specifically affect children; and ensuring high quality and ethical standards in clinical trials involving children, including informed consent.
Developed to complement existing national and regional paediatric medicine groups, the IFPMA task force will also provide expert advice on scientific, technical and policy issues and will contribute to the development of effective public policies.
Earlier this year, the IFPMA added a Paediatric Trials Search facility to its Clinical Trials Portal. The new facility is aimed at making it easier to find online information about ongoing and completed trials of new paediatric medicines.
Child medicine regulations
In January last year, a new regulation came into force involving paediatric investigation plans (PIPs). The new rules meant companies seeking approval of a new medicine or for a new indication, route of administration or pharmaceutical form of an existing product, must submit a PIP detailing their strategy for developing the drug for the paediatric population. Meeting the requirements of a PIP entitles the company to a six-month extension of the product’s supplementary protection certificate.
Waivers from PIPs can be obtained if the drug is unlikely to be effective or unsafe in the paediatric population, the disease is only present in the adult population, or the drug has no significant therapeutic benefit over existing paediatric treatments.
